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Pre-Exposure Prophylaxis for Transgender Women in the US and South America

HPTN 091: Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation for Transgender Women in the Americas: A Vanguard Study

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04742491
Enrollment
304
Registered
2021-02-08
Start date
2021-03-26
Completion date
2024-08-16
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention

Keywords

Transgender women, TGW

Brief summary

A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention co-located with gender-affirming transgender care (hormonal therapy and medical monitoring) and Peer Health Navigation (PHN) using Strengths-Based Case Management (SBCM) professional supervision. Multi-site, open-label study with each participant randomized 1:1 to Immediate Intervention vs. 6-month Deferred Intervention Arms. Both arms will be provided PrEP and sexually transmitted infection (STI) screening and treatment. Participants in the Immediate Intervention Arm will receive co-located gender-affirming medical care and PHN using SBCM starting at the Enrollment Visit. Participants in the Deferred Intervention Arm will receive linkage to external gender-affirming medical care and case management services during the deferred period and will transition to the study intervention six months following the Enrollment Visit.

Detailed description

entered elsewhere

Interventions

DRUGImmediate Intervention Arm

Truvada, Descovy in the United States; Truvada in Brazil

DRUGDeferred Intervention Arm

Truvada, Descovy in the United States; Truvada in Brazil

Sponsors

Gilead Sciences
CollaboratorINDUSTRY
HIV Prevention Trials Network
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Intermediate Intervention Arm vs. Deferred Intervention Arm

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* TGW (assigned male at birth, trans-feminine spectrum - as defined in the SSP Manual - by self-report) who meet all of the following criteria are eligible for inclusion in this study. * Eighteen years or older at the time of screening. * Willing and able to provide informed consent for the study. * Interest in PrEP - as defined in the SSP Manual. * Non-reactive HIV test results at Screening and Enrollment. * Available to return for all study visits and within site catchment area, as defined per site's Standard Operating Procedures (SOP). * At risk for sexually acquiring HIV infection based on self-report of at least one of the following: 1. Any anal or vaginal sex with one or more serodiscordant or HIV-unknown serostatus sexual partners in the previous 3 months, regardless of condom use. 2. Anal or vaginal sex in exchange for money, food, shelter, or other goods or favors in the previous 3 months. 3. History of STI(s) in the past 6 months. * Willing to undergo all required study procedures. * General good health, as evidenced by the following laboratory values: 1. Calculated creatinine clearance ≥ 60 mL/minute using the Cockcroft-Gault equation. 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN.) 3. HBV surface antigen (HBsAg) negative. Note: Otherwise eligible participants with laboratory results outside the above-mentioned values, with the exception of those with reactive HIV test, can be re-tested during the screening window. Participants with reactive HIV tests will not be able to rescreen. Note: Participants who practice receptive vaginal sex cannot be provided Descovy® as it is not approved for this indication.

Exclusion criteria

1. Any reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed. 2. Plans to move away from the site area within the next 18 months. 3. Co-enrollment in any other research study that may interfere with this study (as provided by self-report or other available documentation). Exceptions may be made after consultation with the Clinical Management Committee (CMC). 4. Current or chronic history of liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy). 5. History of deep vein thrombosis, pulmonary embolism, and/or clotting disorder. 6. Active or planned use of medications with significant drug interactions as described in the Package Insert for Truvada® or Descovy®, per clinician's discretion (provided by selfreport or obtained from medical history or medical records). See Section 5.8 for a full list of drug interactions. 7. Any other condition, including but not limited to alcohol or substance abuse and uncontrolled medical condition and/or allergies, that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements.

Design outcomes

Primary

MeasureTime frameDescription
PrEP Uptake0-18 monthsTime to PrEP initiation is defined as the duration from enrollment to the PrEP start date.
PrEP Adherence0-18 monthsSelf-reported adherence to daily PrEP by study visit
Acceptability and Feasibility of Co-located Services0-18 monthsNumber of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits.
Participant Retention at Weeks 26, 52 and 78Weeks 26, 52, 78Participant retention at weeks 26, 52 and 78 by study arm. Retention defined as the number of participants who completed the visit divided by the number of participants who are expected or have completed the visit.
Acceptability and Feasibility of Peer Health Navigation0-18 monthsThe average number of peer health navigator encounters.
PrEP Persistent0-18 monthsPrEP persistent is defined as the proportion of study visits where a participant demonstrates high adherence to PrEP among those who initiated PrEP at the study clinic. High adherence at a visit is based on drug concentrations in dried blood spots (DBS): Truvada (TDF/FTC): TFV-DP ≥ 900 fmol/punch Descovy (TAF/FTC): TFV-DP ≥ 950 fmol/punch PrEP persistent reflects sustained high PrEP adherence across multiple visits over time, rather than high PrEP adherence at a single point.

Secondary

MeasureTime frameDescription
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake0-18 monthsPrEP uptake is defined as whether the participant initiated PrEP at the study clinic during the study cycle.
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits.0-18 monthsThe number of study visits at which participants were highly adherent to PrEP, among those who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS): Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch Arm-level results are presented as the total number of visits at which participants in each arm were highly adherent to PrEP, reported as the number and percentage of visits.
Examining Changes in Sexual Risk-taking Behavior0-18 monthsDescribing condom use with HIV+ people, measured by assessments at enrollment and quarterly through Week 78.
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research0-18 monthsAn overall composite flag (Yes/No) for interest in future HIV research was created at the end of study using participant responses collected at enrollment, weeks 26, 52, and 78. Those who showed interest in future HIV research (Yes) were reported in the outcome measure data table.
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence0-18 monthsPrEP persistence is defined as the proportion of study visits at which a participant demonstrates high adherence to PrEP among participants who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS): Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch PrEP persistence reflects sustained high adherence across multiple visits over time per participant, rather than overall high adherence at all time points. For each participant, this proportion was converted to a percentage; arm-level results are presented as the mean of participant-level percentages in each arm in the outcome measure data table.
Prevalence of STI Infection (GC, CT, Syphilis) at Baseline0 monthsTo determine baseline prevalence of STIs (Neisseria gonorrhoeae \[GC\], Chlamydia trachomatis \[CT\], and Treponema pallidum (syphilis)) by study arm
Estimate Prevalence of Baseline Laboratory Values.0 monthsTo obtain baseline laboratory data to evaluate the cohort's suitability for future PrEP intervention studies (e.g., prevalence of renal insufficiency, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, etc.). Logistic regression models will be used for estimating prevalence of baseline conditions.
Gender-Affirming Hormone Therapy by Visit0-18 monthsTaken hormones for gender identity/transition
Annual Incidence of HIV Infections0-18 monthsThe number of incident HIV infections at each time point by arm. Note: The HIV infection reported at Week 26 occurred during an interim visit between Week 26 and Week 39.
Incidence of STI Infection (GC, CT, Syphilis)0-18 monthsTo determine annual incidence of STIs (Neisseria gonorrhoeae \[GC\], Chlamydia trachomatis \[CT\], and Treponema pallidum (syphilis)) and to examine changes in STI over time by study arm.

Countries

Brazil, United States

Participant flow

Pre-assignment details

All enrolled participants were randomized to study arms.

Participants by arm

ArmCount
Immediate Intervention Arm
PrEP, GAHT and peer-health management was provided from enrollment to study exit.
149
Deferred Intervention Arm
PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
155
Total304

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath20
Overall StudyLost to Follow-up68
Overall StudyOne or more reactive HIV test results or acute HIV infection suspected21
Overall StudyOther reasons34
Overall StudyParticipant refused further participation27
Overall StudyParticipant unable to adhere to visit schedule34
Overall StudyParticipant unwilling or unable to comply with required study procedures11
Overall StudyWithdrawal by Subject42

Baseline characteristics

CharacteristicImmediate Intervention ArmDeferred Intervention ArmTotal
Age, Continuous30.3 years
STANDARD_DEVIATION 8.8
30.9 years
STANDARD_DEVIATION 8.8
30.6 years
STANDARD_DEVIATION 8.8
Age, Customized
25 and below
57 Participants47 Participants104 Participants
Age, Customized
26 and above
92 Participants108 Participants200 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
82 Participants81 Participants163 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
62 Participants72 Participants134 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants2 Participants7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants4 Participants6 Participants
Race (NIH/OMB)
Asian
2 Participants7 Participants9 Participants
Race (NIH/OMB)
Black or African American
46 Participants50 Participants96 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
45 Participants40 Participants85 Participants
Race (NIH/OMB)
White
53 Participants54 Participants107 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
149 Participants155 Participants304 Participants
Sex/Gender, Customized
Gender
Another gender identity
4 Participants5 Participants9 Participants
Sex/Gender, Customized
Gender
Female
28 Participants20 Participants48 Participants
Sex/Gender, Customized
Gender
Gender nonbinary/Genderfluid/Gender Nonconforming
3 Participants9 Participants12 Participants
Sex/Gender, Customized
Gender
Missing
0 Participants1 Participants1 Participants
Sex/Gender, Customized
Gender
Multiple gender identities selected
49 Participants44 Participants93 Participants
Sex/Gender, Customized
Gender
Prefer not to answer
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Gender
Transgender Female/Transgender Woman
65 Participants76 Participants141 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
2 / 1490 / 1550 / 155
other
Total, other adverse events
25 / 14912 / 15518 / 155
serious
Total, serious adverse events
13 / 1493 / 1553 / 155

Outcome results

Primary

Acceptability and Feasibility of Co-located Services

Number of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits.

Time frame: 0-18 months

Population: Enrolled participants. Deferred arm participants receive co-located services at 6 months.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 26109 Participants
Immediate Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 52114 Participants
Immediate Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 13106 Participants
Immediate Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 65115 Participants
Immediate Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 39113 Participants
Immediate Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 78116 Participants
Immediate Intervention ArmAcceptability and Feasibility of Co-located ServicesEnrollment68 Participants
Deferred Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 7893 Participants
Deferred Intervention ArmAcceptability and Feasibility of Co-located ServicesEnrollment0 Participants
Deferred Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 130 Participants
Deferred Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 2666 Participants
Deferred Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 3990 Participants
Deferred Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 5293 Participants
Deferred Intervention ArmAcceptability and Feasibility of Co-located ServicesWeek 6593 Participants
Primary

Acceptability and Feasibility of Co-located Services

Percentage of participants who report desire for co-located services at the end of the study

Time frame: 0-18 months

Population: Participants with a non-missing response to the CASI question concerning desire for co-located services at the end of the study.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmAcceptability and Feasibility of Co-located Services106 Participants
Deferred Intervention ArmAcceptability and Feasibility of Co-located Services107 Participants
p-value: 0.895% CI: [65.89, 80.3]Chi-squared
p-value: 0.895% CI: [64.59, 79.04]Chi-squared
Primary

Acceptability and Feasibility of Peer Health Navigation

Number of each type of peer health navigation encounter.

Time frame: 0-18 months

Population: Total number of peer health navigation encounters by arm.

ArmMeasureGroupValue (COUNT_OF_UNITS)
Immediate Intervention ArmAcceptability and Feasibility of Peer Health NavigationEmail0 Encounters
Immediate Intervention ArmAcceptability and Feasibility of Peer Health NavigationPhone258 Encounters
Immediate Intervention ArmAcceptability and Feasibility of Peer Health NavigationText16 Encounters
Immediate Intervention ArmAcceptability and Feasibility of Peer Health NavigationVideo encounter46 Encounters
Immediate Intervention ArmAcceptability and Feasibility of Peer Health NavigationIn-person519 Encounters
Deferred Intervention ArmAcceptability and Feasibility of Peer Health NavigationVideo encounter47 Encounters
Deferred Intervention ArmAcceptability and Feasibility of Peer Health NavigationIn-person427 Encounters
Deferred Intervention ArmAcceptability and Feasibility of Peer Health NavigationEmail0 Encounters
Deferred Intervention ArmAcceptability and Feasibility of Peer Health NavigationText7 Encounters
Deferred Intervention ArmAcceptability and Feasibility of Peer Health NavigationPhone256 Encounters
Primary

Acceptability and Feasibility of Peer Health Navigation

The average number of peer health navigator encounters.

Time frame: 0-18 months

Population: Enrolled population

ArmMeasureValue (MEAN)Dispersion
Immediate Intervention ArmAcceptability and Feasibility of Peer Health Navigation5.7 encountersStandard Deviation 1.6
Deferred Intervention ArmAcceptability and Feasibility of Peer Health Navigation5.5 encountersStandard Deviation 1.2
Primary

Participant Retention at Weeks 26, 52 and 78

Participant retention at weeks 26, 52 and 78 by study arm. Retention defined as the number of participants who completed the visit divided by the number of participants who are expected or have completed the visit.

Time frame: Weeks 26, 52, 78

Population: The denominators in the table differ from the overall number analyzed because the denominator excludes any participants who have terminated from the study or seroconverted at the time of the visit.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmParticipant Retention at Weeks 26, 52 and 78Week 26125 Participants
Immediate Intervention ArmParticipant Retention at Weeks 26, 52 and 78Week 52115 Participants
Immediate Intervention ArmParticipant Retention at Weeks 26, 52 and 78Week 78126 Participants
Deferred Intervention ArmParticipant Retention at Weeks 26, 52 and 78Week 26135 Participants
Deferred Intervention ArmParticipant Retention at Weeks 26, 52 and 78Week 52123 Participants
Deferred Intervention ArmParticipant Retention at Weeks 26, 52 and 78Week 78128 Participants
Primary

PrEP Adherence

The average number of days to first PrEP permanent discontinuation.

Time frame: 0-18 months

Population: Participants who initiated PrEP and had at least one permanent discontinuation prior to study exit or termination.

ArmMeasureValue (MEAN)Dispersion
Immediate Intervention ArmPrEP Adherence364.1 daysStandard Deviation 185.2
Deferred Intervention ArmPrEP Adherence361.1 daysStandard Deviation 255.2
Primary

PrEP Adherence

The median number of days to first PrEP permanent discontinuation.

Time frame: 0-18 months

Population: Participants who initiated PrEP and had at least one permanent discontinuation prior to study exit or termination.

ArmMeasureValue (MEDIAN)
Immediate Intervention ArmPrEP Adherence373 days
Deferred Intervention ArmPrEP Adherence409 days
Primary

PrEP Adherence

Participants with different levels of TFV-DP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.

Time frame: 0-18 months

Population: TFVDP levels of participants who obtained PrEP at the study clinic.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmPrEP AdherenceWeek 137 doses per week35 Participants
Immediate Intervention ArmPrEP AdherenceWeek 394-6 doses per week22 Participants
Immediate Intervention ArmPrEP AdherenceWeek 13Unquantifiable19 Participants
Immediate Intervention ArmPrEP AdherenceWeek 397 doses per week22 Participants
Immediate Intervention ArmPrEP AdherenceWeek 26Unquantifiable21 Participants
Immediate Intervention ArmPrEP AdherenceWeek 52Unquantifiable29 Participants
Immediate Intervention ArmPrEP AdherenceEnrollment4-6 doses per week5 Participants
Immediate Intervention ArmPrEP AdherenceWeek 52Less than 2 doses per week18 Participants
Immediate Intervention ArmPrEP AdherenceWeek 26Less than 2 doses per week23 Participants
Immediate Intervention ArmPrEP AdherenceWeek 522-3 doses per week14 Participants
Immediate Intervention ArmPrEP AdherenceWeek 13Less than 2 doses per week23 Participants
Immediate Intervention ArmPrEP AdherenceWeek 524-6 doses per week19 Participants
Immediate Intervention ArmPrEP AdherenceWeek 262-3 doses per week8 Participants
Immediate Intervention ArmPrEP AdherenceWeek 527 doses per week20 Participants
Immediate Intervention ArmPrEP AdherenceEnrollment2-3 doses per week5 Participants
Immediate Intervention ArmPrEP AdherenceWeek 65Unquantifiable27 Participants
Immediate Intervention ArmPrEP AdherenceWeek 264-6 doses per week32 Participants
Immediate Intervention ArmPrEP AdherenceWeek 65Less than 2 doses per week19 Participants
Immediate Intervention ArmPrEP AdherenceWeek 132-3 doses per week6 Participants
Immediate Intervention ArmPrEP AdherenceWeek 652-3 doses per week12 Participants
Immediate Intervention ArmPrEP AdherenceWeek 267 doses per week24 Participants
Immediate Intervention ArmPrEP AdherenceWeek 654-6 doses per week17 Participants
Immediate Intervention ArmPrEP AdherenceEnrollment7 doses per week5 Participants
Immediate Intervention ArmPrEP AdherenceWeek 657 doses per week23 Participants
Immediate Intervention ArmPrEP AdherenceWeek 39Unquantifiable31 Participants
Immediate Intervention ArmPrEP AdherenceWeek 78Unquantifiable39 Participants
Immediate Intervention ArmPrEP AdherenceWeek 134-6 doses per week28 Participants
Immediate Intervention ArmPrEP AdherenceWeek 78Less than 2 doses per week22 Participants
Immediate Intervention ArmPrEP AdherenceWeek 39Less than 2 doses per week19 Participants
Immediate Intervention ArmPrEP AdherenceWeek 782-3 doses per week10 Participants
Immediate Intervention ArmPrEP AdherenceEnrollmentLess than 2 doses per week10 Participants
Immediate Intervention ArmPrEP AdherenceWeek 784-6 doses per week16 Participants
Immediate Intervention ArmPrEP AdherenceWeek 392-3 doses per week6 Participants
Immediate Intervention ArmPrEP AdherenceWeek 787 doses per week23 Participants
Immediate Intervention ArmPrEP AdherenceEnrollmentUnquantifiable80 Participants
Deferred Intervention ArmPrEP AdherenceWeek 787 doses per week27 Participants
Deferred Intervention ArmPrEP AdherenceEnrollmentUnquantifiable83 Participants
Deferred Intervention ArmPrEP AdherenceEnrollmentLess than 2 doses per week15 Participants
Deferred Intervention ArmPrEP AdherenceEnrollment2-3 doses per week3 Participants
Deferred Intervention ArmPrEP AdherenceEnrollment4-6 doses per week12 Participants
Deferred Intervention ArmPrEP AdherenceEnrollment7 doses per week4 Participants
Deferred Intervention ArmPrEP AdherenceWeek 13Unquantifiable10 Participants
Deferred Intervention ArmPrEP AdherenceWeek 13Less than 2 doses per week25 Participants
Deferred Intervention ArmPrEP AdherenceWeek 132-3 doses per week10 Participants
Deferred Intervention ArmPrEP AdherenceWeek 134-6 doses per week27 Participants
Deferred Intervention ArmPrEP AdherenceWeek 137 doses per week43 Participants
Deferred Intervention ArmPrEP AdherenceWeek 26Unquantifiable20 Participants
Deferred Intervention ArmPrEP AdherenceWeek 26Less than 2 doses per week28 Participants
Deferred Intervention ArmPrEP AdherenceWeek 262-3 doses per week12 Participants
Deferred Intervention ArmPrEP AdherenceWeek 264-6 doses per week26 Participants
Deferred Intervention ArmPrEP AdherenceWeek 267 doses per week34 Participants
Deferred Intervention ArmPrEP AdherenceWeek 39Unquantifiable23 Participants
Deferred Intervention ArmPrEP AdherenceWeek 39Less than 2 doses per week19 Participants
Deferred Intervention ArmPrEP AdherenceWeek 392-3 doses per week9 Participants
Deferred Intervention ArmPrEP AdherenceWeek 394-6 doses per week27 Participants
Deferred Intervention ArmPrEP AdherenceWeek 397 doses per week34 Participants
Deferred Intervention ArmPrEP AdherenceWeek 52Unquantifiable22 Participants
Deferred Intervention ArmPrEP AdherenceWeek 52Less than 2 doses per week17 Participants
Deferred Intervention ArmPrEP AdherenceWeek 522-3 doses per week8 Participants
Deferred Intervention ArmPrEP AdherenceWeek 524-6 doses per week32 Participants
Deferred Intervention ArmPrEP AdherenceWeek 527 doses per week31 Participants
Deferred Intervention ArmPrEP AdherenceWeek 65Unquantifiable21 Participants
Deferred Intervention ArmPrEP AdherenceWeek 65Less than 2 doses per week26 Participants
Deferred Intervention ArmPrEP AdherenceWeek 652-3 doses per week9 Participants
Deferred Intervention ArmPrEP AdherenceWeek 654-6 doses per week22 Participants
Deferred Intervention ArmPrEP AdherenceWeek 657 doses per week35 Participants
Deferred Intervention ArmPrEP AdherenceWeek 78Unquantifiable32 Participants
Deferred Intervention ArmPrEP AdherenceWeek 78Less than 2 doses per week20 Participants
Deferred Intervention ArmPrEP AdherenceWeek 782-3 doses per week12 Participants
Deferred Intervention ArmPrEP AdherenceWeek 784-6 doses per week23 Participants
Primary

PrEP Adherence

Participants with different levels FTC-TP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.

Time frame: 0-18 months

Population: FTC-TP levels of participants who obtained PrEP at the study clinic.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmPrEP AdherenceWeek 6555 Participants
Immediate Intervention ArmPrEP AdherenceEnrollment15 Participants
Immediate Intervention ArmPrEP AdherenceWeek 1373 Participants
Immediate Intervention ArmPrEP AdherenceWeek 2667 Participants
Immediate Intervention ArmPrEP AdherenceWeek 3951 Participants
Immediate Intervention ArmPrEP AdherenceWeek 5252 Participants
Immediate Intervention ArmPrEP AdherenceWeek 7851 Participants
Deferred Intervention ArmPrEP AdherenceWeek 6570 Participants
Deferred Intervention ArmPrEP AdherenceWeek 3975 Participants
Deferred Intervention ArmPrEP AdherenceEnrollment20 Participants
Deferred Intervention ArmPrEP AdherenceWeek 7859 Participants
Deferred Intervention ArmPrEP AdherenceWeek 1387 Participants
Deferred Intervention ArmPrEP AdherenceWeek 5275 Participants
Deferred Intervention ArmPrEP AdherenceWeek 2674 Participants
Primary

PrEP Adherence

Self-reported adherence to daily PrEP by study visit

Time frame: 0-18 months

Population: Number of participants who completed CASI at each study visit. Due to missingness, this number may be lower than the number of participants enrolled in the study.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmPrEP AdherenceWeek 13Missing30 Participants
Immediate Intervention ArmPrEP AdherenceWeek 397 doses per week61 Participants
Immediate Intervention ArmPrEP AdherenceWeek 13< 2 doses per week3 Participants
Immediate Intervention ArmPrEP AdherenceWeek 39Missing30 Participants
Immediate Intervention ArmPrEP AdherenceWeek 26< 2 doses per week7 Participants
Immediate Intervention ArmPrEP AdherenceWeek 52< 2 doses per week4 Participants
Immediate Intervention ArmPrEP AdherenceEnrollment7 doses per week19 Participants
Immediate Intervention ArmPrEP AdherenceWeek 522-3 doses per week3 Participants
Immediate Intervention ArmPrEP AdherenceWeek 262-3 doses per week7 Participants
Immediate Intervention ArmPrEP AdherenceWeek 524-6 doses per week18 Participants
Immediate Intervention ArmPrEP AdherenceWeek 132-3 doses per week2 Participants
Immediate Intervention ArmPrEP AdherenceWeek 527 doses per week53 Participants
Immediate Intervention ArmPrEP AdherenceWeek 264-6 doses per week12 Participants
Immediate Intervention ArmPrEP AdherenceWeek 52Missing37 Participants
Immediate Intervention ArmPrEP AdherenceEnrollment4-6 doses per week6 Participants
Immediate Intervention ArmPrEP AdherenceWeek 65< 2 doses per week2 Participants
Immediate Intervention ArmPrEP AdherenceWeek 267 doses per week76 Participants
Immediate Intervention ArmPrEP AdherenceWeek 652-3 doses per week1 Participants
Immediate Intervention ArmPrEP AdherenceWeek 134-6 doses per week19 Participants
Immediate Intervention ArmPrEP AdherenceWeek 654-6 doses per week16 Participants
Immediate Intervention ArmPrEP AdherenceWeek 26Missing22 Participants
Immediate Intervention ArmPrEP AdherenceWeek 657 doses per week57 Participants
Immediate Intervention ArmPrEP AdherenceEnrollmentMissing118 Participants
Immediate Intervention ArmPrEP AdherenceWeek 65Missing33 Participants
Immediate Intervention ArmPrEP AdherenceWeek 39< 2 doses per week4 Participants
Immediate Intervention ArmPrEP AdherenceWeek 78< 2 doses per week3 Participants
Immediate Intervention ArmPrEP AdherenceWeek 137 doses per week79 Participants
Immediate Intervention ArmPrEP AdherenceWeek 782-3 doses per week7 Participants
Immediate Intervention ArmPrEP AdherenceWeek 392-3 doses per week3 Participants
Immediate Intervention ArmPrEP AdherenceWeek 784-6 doses per week17 Participants
Immediate Intervention ArmPrEP AdherenceEnrollment2-3 doses per week2 Participants
Immediate Intervention ArmPrEP AdherenceWeek 787 doses per week51 Participants
Immediate Intervention ArmPrEP AdherenceWeek 394-6 doses per week16 Participants
Immediate Intervention ArmPrEP AdherenceWeek 78Missing47 Participants
Immediate Intervention ArmPrEP AdherenceEnrollment< 2 doses per week2 Participants
Deferred Intervention ArmPrEP AdherenceWeek 78Missing36 Participants
Deferred Intervention ArmPrEP AdherenceEnrollment< 2 doses per week1 Participants
Deferred Intervention ArmPrEP AdherenceEnrollment2-3 doses per week3 Participants
Deferred Intervention ArmPrEP AdherenceEnrollment4-6 doses per week4 Participants
Deferred Intervention ArmPrEP AdherenceEnrollment7 doses per week20 Participants
Deferred Intervention ArmPrEP AdherenceEnrollmentMissing125 Participants
Deferred Intervention ArmPrEP AdherenceWeek 13< 2 doses per week8 Participants
Deferred Intervention ArmPrEP AdherenceWeek 132-3 doses per week3 Participants
Deferred Intervention ArmPrEP AdherenceWeek 134-6 doses per week27 Participants
Deferred Intervention ArmPrEP AdherenceWeek 137 doses per week75 Participants
Deferred Intervention ArmPrEP AdherenceWeek 13Missing26 Participants
Deferred Intervention ArmPrEP AdherenceWeek 26< 2 doses per week7 Participants
Deferred Intervention ArmPrEP AdherenceWeek 262-3 doses per week2 Participants
Deferred Intervention ArmPrEP AdherenceWeek 264-6 doses per week21 Participants
Deferred Intervention ArmPrEP AdherenceWeek 267 doses per week72 Participants
Deferred Intervention ArmPrEP AdherenceWeek 26Missing29 Participants
Deferred Intervention ArmPrEP AdherenceWeek 39< 2 doses per week4 Participants
Deferred Intervention ArmPrEP AdherenceWeek 392-3 doses per week5 Participants
Deferred Intervention ArmPrEP AdherenceWeek 394-6 doses per week23 Participants
Deferred Intervention ArmPrEP AdherenceWeek 397 doses per week71 Participants
Deferred Intervention ArmPrEP AdherenceWeek 39Missing25 Participants
Deferred Intervention ArmPrEP AdherenceWeek 52< 2 doses per week5 Participants
Deferred Intervention ArmPrEP AdherenceWeek 522-3 doses per week5 Participants
Deferred Intervention ArmPrEP AdherenceWeek 524-6 doses per week16 Participants
Deferred Intervention ArmPrEP AdherenceWeek 527 doses per week63 Participants
Deferred Intervention ArmPrEP AdherenceWeek 52Missing31 Participants
Deferred Intervention ArmPrEP AdherenceWeek 65< 2 doses per week5 Participants
Deferred Intervention ArmPrEP AdherenceWeek 652-3 doses per week5 Participants
Deferred Intervention ArmPrEP AdherenceWeek 654-6 doses per week21 Participants
Deferred Intervention ArmPrEP AdherenceWeek 657 doses per week61 Participants
Deferred Intervention ArmPrEP AdherenceWeek 65Missing30 Participants
Deferred Intervention ArmPrEP AdherenceWeek 78< 2 doses per week9 Participants
Deferred Intervention ArmPrEP AdherenceWeek 782-3 doses per week7 Participants
Deferred Intervention ArmPrEP AdherenceWeek 784-6 doses per week16 Participants
Deferred Intervention ArmPrEP AdherenceWeek 787 doses per week61 Participants
Primary

PrEP Adherence

The proportion of TGW determined to be adherent at the Week 26 visit was compared by study arm. PrEP adherence was defined as having a detectable concentration of PrEP (Truvada or Descovy) in DBS sample.

Time frame: Week 26

Population: Participants who obtained PrEP at the study clinic.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmPrEP Adherence87 Participants
Deferred Intervention ArmPrEP Adherence100 Participants
p-value: 0.59Binomial Distribution
Primary

PrEP Persistent

PrEP persistent is defined as the proportion of study visits where a participant demonstrates high adherence to PrEP among those who initiated PrEP at the study clinic. High adherence at a visit is based on drug concentrations in dried blood spots (DBS): Truvada (TDF/FTC): TFV-DP ≥ 900 fmol/punch Descovy (TAF/FTC): TFV-DP ≥ 950 fmol/punch PrEP persistent reflects sustained high PrEP adherence across multiple visits over time, rather than high PrEP adherence at a single point.

Time frame: 0-18 months

Population: Participants who obtained PrEP at the study clinic.

ArmMeasureValue (MEAN)Dispersion
Immediate Intervention ArmPrEP Persistent41.7 percent of visitsStandard Deviation 40.9
Deferred Intervention ArmPrEP Persistent50.5 percent of visitsStandard Deviation 43.2
Primary

PrEP Uptake

Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date.

Time frame: 0-18 months

Population: Limited to participants who obtained PrEP at the study clinic

ArmMeasureValue (MEAN)Dispersion
Immediate Intervention ArmPrEP Uptake16.2 daysStandard Deviation 66.7
Deferred Intervention ArmPrEP Uptake11.4 daysStandard Deviation 4.3
Primary

PrEP Uptake

Comparison of PrEP uptake between study arms at the end of Week 26. PrEP uptake is defined as whether the participant initiated PrEP at the study clinic..

Time frame: Week 26

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmPrEP Uptake127 Participants
Deferred Intervention ArmPrEP Uptake135 Participants
p-value: 0.638195% CI: [79.54, 90.93]Binomial Distribution
p-value: 0.638195% CI: [81.82, 92.37]Binomial Distribution
Secondary

Annual Incidence of HIV Infections

The number of incident HIV infections at each time point by arm. Note: The HIV infection reported at Week 26 occurred during an interim visit between Week 26 and Week 39.

Time frame: 0-18 months

Population: Enrolled participants

ArmMeasureGroupValue (NUMBER)
Immediate Intervention ArmAnnual Incidence of HIV InfectionsWeek 520 participants
Immediate Intervention ArmAnnual Incidence of HIV InfectionsWeek 392 participants
Immediate Intervention ArmAnnual Incidence of HIV InfectionsWeek 130 participants
Immediate Intervention ArmAnnual Incidence of HIV InfectionsWeek 650 participants
Immediate Intervention ArmAnnual Incidence of HIV InfectionsEnrollment0 participants
Immediate Intervention ArmAnnual Incidence of HIV InfectionsWeek 782 participants
Immediate Intervention ArmAnnual Incidence of HIV InfectionsWeek 261 participants
Deferred Intervention ArmAnnual Incidence of HIV InfectionsWeek 780 participants
Deferred Intervention ArmAnnual Incidence of HIV InfectionsEnrollment0 participants
Deferred Intervention ArmAnnual Incidence of HIV InfectionsWeek 130 participants
Deferred Intervention ArmAnnual Incidence of HIV InfectionsWeek 260 participants
Deferred Intervention ArmAnnual Incidence of HIV InfectionsWeek 520 participants
Deferred Intervention ArmAnnual Incidence of HIV InfectionsWeek 650 participants
Deferred Intervention ArmAnnual Incidence of HIV InfectionsWeek 391 participants
Comparison: Poisson regression models with person time were used to estimate HIV incidence for the immediate intervention arm.95% CI: [0.72, 5.12]
Comparison: Poisson regression models with person time was used to estimate HIV incidence for the deferred intervention arm.95% CI: [0.07, 3.39]
Secondary

Estimate Prevalence of Baseline Laboratory Values.

To obtain baseline laboratory data to evaluate the cohort's suitability for future PrEP intervention studies (e.g., prevalence of renal insufficiency, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, etc.). Logistic regression models will be used for estimating prevalence of baseline conditions.

Time frame: 0 months

Population: Enrolled participants. There is insufficient data (below the lower limit of quantification) to perform valid logistic regression modelling on participants with Hepatitis B or renal insufficiency at baseline.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmEstimate Prevalence of Baseline Laboratory Values.Hepatitis B Infection0 Participants
Immediate Intervention ArmEstimate Prevalence of Baseline Laboratory Values.Hepatitis C Infection2 Participants
Immediate Intervention ArmEstimate Prevalence of Baseline Laboratory Values.Renal Insufficiency0 Participants
Deferred Intervention ArmEstimate Prevalence of Baseline Laboratory Values.Hepatitis B Infection1 Participants
Deferred Intervention ArmEstimate Prevalence of Baseline Laboratory Values.Hepatitis C Infection3 Participants
Deferred Intervention ArmEstimate Prevalence of Baseline Laboratory Values.Renal Insufficiency0 Participants
Comparison: Logistic regression results of Hepatitis C infection at baseline.p-value: 0.6995% CI: [0.24, 8.81]Regression, Logistic
Secondary

Examining Changes in Sexual Risk-taking Behavior

Frequency of being high on drugs/drunk during sex, measured by assessments at enrollment and quarterly through Week 78.

Time frame: 0-18 months

Population: Number of participants who completed CASI questionnaire per visit.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentLess than half the time34 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAbout half the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMore than half of the time12 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAll of the time7 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentPrefer not to answer1 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No sex11 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Oral sex only10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13None of the time72 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Less than half the time19 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13About half the time9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13More than half of the time4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13All of the time7 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Prefer not to answer1 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No sex18 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Oral sex only17 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26None of the time57 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Less than half the time21 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26About half the time2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26More than half of the time2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26All of the time5 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Prefer not to answer2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No sex13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Oral sex only13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39None of the time51 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Less than half the time18 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39About half the time8 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39More than half of the time5 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39All of the time3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Prefer not to answer3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Missing4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No sex18 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Oral sex only2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52None of the time54 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Less than half the time21 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52About half the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52More than half of the time3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52All of the time4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Prefer not to answer3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Missing4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No sex16 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Oral sex only6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65None of the time58 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Less than half the time15 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65About half the time5 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65More than half of the time2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65All of the time2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Prefer not to answer1 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Missing9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No sex23 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Oral sex only2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78None of the time57 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Less than half the time18 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78About half the time5 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78More than half of the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78All of the time4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Prefer not to answer1 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMissing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo sex9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentOral sex only10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNone of the time68 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Prefer not to answer1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentLess than half the time40 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65More than half of the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAbout half the time13 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Missing6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMore than half of the time15 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78About half the time11 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAll of the time10 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No sex12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentPrefer not to answer3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65All of the time4 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Missing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Oral sex only9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No sex16 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMissing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Oral sex only8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52None of the time47 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13None of the time53 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Prefer not to answer4 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Less than half the time27 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Less than half the time25 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13About half the time16 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78More than half of the time5 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13More than half of the time12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52About half the time8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13All of the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Missing4 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Prefer not to answer3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52More than half of the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Missing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentOral sex only7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No sex14 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52All of the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Oral sex only9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No sex20 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26None of the time54 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Prefer not to answer1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Less than half the time33 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78All of the time4 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26About half the time8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Missing7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26More than half of the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Oral sex only0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26All of the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No sex18 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Prefer not to answer0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo sex12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Missing2 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Oral sex only2 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No sex13 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78None of the time55 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Oral sex only9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65None of the time51 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39None of the time51 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Prefer not to answer1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Less than half the time28 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Less than half the time22 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39About half the time11 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Less than half the time29 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39More than half of the time7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65About half the time11 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39All of the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNone of the time52 Participants
Secondary

Examining Changes in Sexual Risk-taking Behavior

Had sex for money/drugs/housing/food/other things, measured by assessments at enrollment and quarterly through Week 78.

Time frame: 0-18 months

Population: Number of participants who completed CASI questionnaire per visit.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Prefer not to answer1 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Prefer not to answer3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMissing147 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentYes0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentPrefer not to answer0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No90 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Yes40 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Prefer not to answer3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No85 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Prefer not to answer3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No83 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Yes29 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Prefer not to answer2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Missing2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No75 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Yes37 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Yes36 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No77 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Yes29 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No90 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Yes32 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Prefer not to answer3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Missing0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Yes24 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Yes21 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Prefer not to answer5 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Prefer not to answer2 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No104 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMissing153 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Missing0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Yes21 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentYes0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Missing0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentPrefer not to answer0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Prefer not to answer3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Missing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Yes19 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No101 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Missing0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Yes32 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No99 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Prefer not to answer5 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No92 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Missing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No107 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No101 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Yes23 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Prefer not to answer5 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Prefer not to answer3 Participants
Secondary

Examining Changes in Sexual Risk-taking Behavior

Describing condom use with HIV unknown people, measured by assessments at enrollment and quarterly through Week 78.

Time frame: 0-18 months

Population: The numbers presented in Overall Number of Participants Analyzed represent the total number of participants enrolled in the study. For each visit (row), only participants who completed the CASI questionnaire were included in the analysis. For both questions condom use with HIV+ people and condom use with HIV unknown people analyses were restricted to participants who completed the CASI questionnaire at that visit.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39None of the time13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13More than half of the time16 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Less than half the time10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39About half the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13All of the time19 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39More than half of the time9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentLess than half the time20 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39All of the time13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Missing4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No sex11 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No sex18 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No sex18 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Oral sex only2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMissing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No sex with anyone whose HIV status was unknown40 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo sex with anyone whose HIV status was unknown30 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52None of the time11 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Oral sex only17 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Less than half the time8 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Oral sex only10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52About half the time5 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No sex with anyone whose HIV status was unknown28 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52More than half of the time13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAbout half the time13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52All of the time14 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26None of the time14 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Missing4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentOral sex only10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No sex16 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Less than half the time11 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Oral sex only6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No sex with anyone whose HIV status was unknown42 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No sex with anyone whose HIV status was unknown34 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65None of the time16 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26About half the time7 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Less than half the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMore than half of the time18 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65About half the time2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26More than half of the time13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65More than half of the time7 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13None of the time24 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65All of the time10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26All of the time16 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Missing9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNone of the time20 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No sex23 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Oral sex only2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Less than half the time9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No sex with anyone whose HIV status was unknown44 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No sex13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78None of the time15 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAll of the time27 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Less than half the time11 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Oral sex only13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78About half the time2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13About half the time10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78More than half of the time9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No sex with anyone whose HIV status was unknown37 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78All of the time10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo sex9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Oral sex only9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMissing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo sex12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentOral sex only7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo sex with anyone whose HIV status was unknown37 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNone of the time17 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentLess than half the time19 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAbout half the time9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMore than half of the time22 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAll of the time29 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Missing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No sex16 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Oral sex only8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Oral sex only2 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No sex with anyone whose HIV status was unknown34 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13None of the time19 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Less than half the time15 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13About half the time5 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13More than half of the time19 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13All of the time22 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Missing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No sex14 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Oral sex only9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No sex with anyone whose HIV status was unknown40 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26None of the time21 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Less than half the time13 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26About half the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26More than half of the time10 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26All of the time17 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Missing2 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No sex13 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Oral sex only9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No sex with anyone whose HIV status was unknown50 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39None of the time10 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Less than half the time10 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39About half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39More than half of the time10 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39All of the time21 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Missing6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No sex12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No sex with anyone whose HIV status was unknown53 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52None of the time9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Less than half the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52About half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52More than half of the time4 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52All of the time18 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Missing7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No sex18 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No sex with anyone whose HIV status was unknown46 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65None of the time15 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Less than half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65About half the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65More than half of the time9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65All of the time16 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Missing4 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No sex20 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Oral sex only0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No sex with anyone whose HIV status was unknown53 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78None of the time15 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Less than half the time5 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78About half the time7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78More than half of the time8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78All of the time17 Participants
Secondary

Examining Changes in Sexual Risk-taking Behavior

Describing condom use with HIV+ people, measured by assessments at enrollment and quarterly through Week 78.

Time frame: 0-18 months

Population: The numbers presented in Overall Number of Participants Analyzed represent the total number of participants enrolled in the study. For each visit (row), only participants who completed the CASI questionnaire were included in the analysis. For both questions condom use with HIV+ people and condom use with HIV unknown people analyses were restricted to participants who completed the CASI questionnaire at that visit.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39None of the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMissing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Less than half the time3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13More than half the time9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39About half the time2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAll of the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39More than half the time4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13All of the time8 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39All of the time5 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNone of the time11 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Missing4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No sex18 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Oral sex only2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No sex18 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52I did not have sex with anyone whom I knew was HIV+65 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentOral sex only10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52None of the time7 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Oral sex only17 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Less than half the time4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No sex11 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52About half the time1 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26I did not have sex with anyone whom I knew was HIV+69 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52More than half the time5 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentLess than half the time3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52All of the time9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26None of the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Missing4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Oral sex only10 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No sex16 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Less than half the time3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Oral sex only6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo sex9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65I did not have sex with anyone whom I knew was HIV+62 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26About half the time3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65None of the time5 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13I did not have sex with anyone whom I knew was HIV+81 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Less than half the time4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26More than half the time1 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65About half the time2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAbout half the time2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65More than half the time3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26All of the time7 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65All of the time7 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13None of the time7 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Missing9 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Missing0 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No sex23 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentI did not have sex with anyone whom I knew was HIV+101 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Oral sex only2 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No sex13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78I did not have sex with anyone whom I knew was HIV+70 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Less than half the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78None of the time4 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Oral sex only13 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Less than half the time3 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMore than half the time5 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78About half the time6 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39I did not have sex with anyone whom I knew was HIV+68 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78More than half the time1 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13About half the time1 Participants
Immediate Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78All of the time7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78All of the time8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMissing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNo sex12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentOral sex only7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentI did not have sex with anyone whom I knew was HIV+88 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentNone of the time19 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentLess than half the time7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAbout half the time4 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentMore than half the time4 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorEnrollmentAll of the time11 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Missing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13No sex16 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Oral sex only8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13I did not have sex with anyone whom I knew was HIV+87 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13None of the time8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13Less than half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13About half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13More than half the time1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 13All of the time12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Missing1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26No sex14 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Oral sex only9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26I did not have sex with anyone whom I knew was HIV+80 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26None of the time8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26Less than half the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26About half the time1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26More than half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 26All of the time9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Missing2 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39No sex13 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Oral sex only9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39I did not have sex with anyone whom I knew was HIV+75 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39None of the time12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39Less than half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39About half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39More than half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 39All of the time8 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Missing6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52No sex12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Oral sex only9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52I did not have sex with anyone whom I knew was HIV+67 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52None of the time12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52Less than half the time5 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52About half the time2 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52More than half the time1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 52All of the time6 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Missing7 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65No sex18 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Oral sex only2 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65I did not have sex with anyone whom I knew was HIV+70 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65None of the time9 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65Less than half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65About half the time1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65More than half the time0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 65All of the time12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Missing4 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78No sex20 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Oral sex only0 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78I did not have sex with anyone whom I knew was HIV+79 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78None of the time12 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78Less than half the time3 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78About half the time1 Participants
Deferred Intervention ArmExamining Changes in Sexual Risk-taking BehaviorWeek 78More than half the time2 Participants
Secondary

Gender-Affirming Hormone Therapy by Visit

Taken hormones for gender identity/transition

Time frame: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 2693 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 5286 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 1391 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 6582 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 3985 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 7893 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment96 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 7896 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment101 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 1396 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 2693 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 3996 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 5293 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 6590 Participants
Secondary

Gender-Affirming Hormone Therapy by Visit

Ever had vaginoplasty/labiaplasty/SRS/GRS/GCS

Time frame: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 261 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 521 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 131 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 651 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 391 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 782 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment7 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 781 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment7 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 130 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 260 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 391 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 520 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 650 Participants
Secondary

Gender-Affirming Hormone Therapy by Visit

Ever had breast augmentation/surgery

Time frame: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 265 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 525 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 133 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 654 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 393 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 781 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment36 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 781 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment25 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 131 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 261 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 391 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 520 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 650 Participants
Secondary

Gender-Affirming Hormone Therapy by Visit

Ever had a substance (like silicone or other fillers) injected to fill out face or make figure look more womanly

Time frame: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 265 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 526 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 132 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 653 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 395 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 784 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment27 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 785 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment29 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 135 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 264 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 393 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 527 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 653 Participants
Secondary

Gender-Affirming Hormone Therapy by Visit

Where do you currently get your hormones?

Time frame: 0-18 months

Population: Number of participants who reported they were currently taking hormones.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentSome other source6 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Medical providers and from friends, online, or other sources14 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Some other source6 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Only from friends, online, or other non-licensed sources3 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentMedical providers and from friends, online, or other sources14 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Some other source2 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Missing0 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Missing0 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Only from medical providers69 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Missing0 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Medical providers and from friends, online, or other sources10 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Only from medical providers68 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Only from friends, online, or other non-licensed sources4 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentOnly from medical providers47 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Medical providers and from friends, online, or other sources13 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Missing0 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Only from medical providers70 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Only from medical providers59 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Only from friends, online, or other non-licensed sources1 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Medical providers and from friends, online, or other sources17 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentOnly from friends, online, or other non-licensed sources16 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Only from friends, online, or other non-licensed sources2 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Some other source7 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Some other source1 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Medical providers and from friends, online, or other sources11 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Missing0 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentMissing0 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Only from medical providers68 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Missing0 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Medical providers and from friends, online, or other sources17 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Only from friends, online, or other non-licensed sources1 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Only from friends, online, or other non-licensed sources5 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Only from medical providers65 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Some other source0 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Some other source2 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Some other source0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentMissing0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentOnly from medical providers50 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentMedical providers and from friends, online, or other sources11 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentOnly from friends, online, or other non-licensed sources21 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollmentSome other source8 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Missing0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Only from medical providers72 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Medical providers and from friends, online, or other sources13 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Only from friends, online, or other non-licensed sources3 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 13Some other source4 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Missing0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Only from medical providers80 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Medical providers and from friends, online, or other sources7 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Only from friends, online, or other non-licensed sources4 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Some other source3 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 26Some other source0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Missing0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Only from medical providers78 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Medical providers and from friends, online, or other sources9 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 39Only from friends, online, or other non-licensed sources0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Missing0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Only from medical providers74 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Medical providers and from friends, online, or other sources13 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Only from friends, online, or other non-licensed sources1 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 52Some other source0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Missing0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Only from medical providers70 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Medical providers and from friends, online, or other sources17 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Only from friends, online, or other non-licensed sources1 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 65Some other source0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Missing0 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Only from medical providers71 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Medical providers and from friends, online, or other sources18 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 78Only from friends, online, or other non-licensed sources2 Participants
Secondary

Gender-Affirming Hormone Therapy by Visit

Currently taking hormones for gender identity/transition

Time frame: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 2689 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 5285 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment83 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 6579 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 3984 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 7890 Participants
Immediate Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 1388 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 7891 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitEnrollment90 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 1392 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 2691 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 3990 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 5288 Participants
Deferred Intervention ArmGender-Affirming Hormone Therapy by VisitWeek 6588 Participants
Secondary

Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits.

The number of study visits at which participants were highly adherent to PrEP, among those who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS): Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch Arm-level results are presented as the total number of visits at which participants in each arm were highly adherent to PrEP, reported as the number and percentage of visits.

Time frame: 0-18 months

Population: A total of 268 participants initiated PrEP at the study clinic. High PrEP adherence was assessed across 1,533 study visits.

ArmMeasureValue (COUNT_OF_UNITS)
Immediate Intervention ArmIdentify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits.291 Visits
Deferred Intervention ArmIdentify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits.377 Visits
Comparison: Multivariable GEE modeling the probability of high PrEP adherence with predictor emotional violence adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to visits with complete data (1518 of 1533 visits). This section provides p-values and odds ratio estimates for emotional violence.p-value: 0.895% CI: [0.64, 1.4]GEE
Comparison: Multivariable GEE modeling the probability of high PrEP adherence with predictor emotional violence adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to visits with complete data (1518 of 1533 visits). This section provides p-values and odds ratio estimates for emotional violence.p-value: 0.00495% CI: [1.35, 4.92]GEE
Secondary

Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research

An overall composite flag (Yes/No) for interest in future HIV research was created at the end of study using participant responses collected at enrollment, weeks 26, 52, and 78. Those who showed interest in future HIV research (Yes) were reported in the outcome measure data table.

Time frame: 0-18 months

Population: All enrolled participants.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmIdentify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research149 Participants
Deferred Intervention ArmIdentify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research153 Participants
Secondary

Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence

PrEP persistence is defined as the proportion of study visits at which a participant demonstrates high adherence to PrEP among participants who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS): Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch PrEP persistence reflects sustained high adherence across multiple visits over time per participant, rather than overall high adherence at all time points. For each participant, this proportion was converted to a percentage; arm-level results are presented as the mean of participant-level percentages in each arm in the outcome measure data table.

Time frame: 0-18 months

Population: Participants who obtained PrEP at the study clinic.

ArmMeasureValue (MEAN)Dispersion
Immediate Intervention ArmIdentify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence41.7 Percentage of VisitsStandard Error 40.9
Deferred Intervention ArmIdentify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence50.5 Percentage of VisitsStandard Error 43.2
Comparison: Multivariable linear regression of PrEP persistence with predictors highest level of education and emotional violence adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for highest level of education.p-value: 0.0895% CI: [-0.39, 0.02]Regression, Linear
Comparison: Multivariable linear regression of PrEP persistence with predictors highest level of education, and emotional violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for the highest level of education.p-value: 0.0695% CI: [-0.22, 0.003]Regression, Linear
Comparison: Multivariable linear regression of PrEP persistence with predictors highest level of education, and emotional violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for emotional violence.p-value: 0.7695% CI: [-0.12, 0.09]Regression, Linear
Comparison: Multivariable linear regression of PrEP persistence with predictors highest level of education, and emotional violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for emotional violence.p-value: 0.0995% CI: [-0.06, 0.78]Regression, Linear
Secondary

Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake

PrEP uptake is defined as whether the participant initiated PrEP at the study clinic during the study cycle.

Time frame: 0-18 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmIdentify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake131 Participants
Deferred Intervention ArmIdentify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake137 Participants
Comparison: Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section presents p-values and odds ratios for age.p-value: 0.0895% CI: [0.89, 6.69]Regression, Logistic
Comparison: Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section provides p-values and odds ratio estimates for education.p-value: 0.3795% CI: [0.05, 3.16]Regression, Logistic
Comparison: Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section provides p-values and odds ratio estimates for education.p-value: 0.0495% CI: [0.17, 0.98]Regression, Logistic
Comparison: Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section provides p-values and odds ratio estimates for physical violence.p-value: 0.0795% CI: [0.98, 5.28]Regression, Logistic
Comparison: Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304).This section provides p-values and odds ratio estimates for physical violence.p-value: 0.9795% CI: [0.001, 999.99]Regression, Logistic
Secondary

Incidence of STI Infection (GC, CT, Syphilis)

To determine annual incidence of STIs (Neisseria gonorrhoeae \[GC\], Chlamydia trachomatis \[CT\], and Treponema pallidum (syphilis)) and to examine changes in STI over time by study arm.

Time frame: 0-18 months

Population: Enrolled participants

ArmMeasureGroupValue (NUMBER)
Immediate Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 657 participants
Immediate Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 788 participants
Immediate Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Number of STI infections (first incidence)51 participants
Immediate Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 138 participants
Immediate Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 2617 participants
Immediate Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 394 participants
Immediate Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 527 participants
Deferred Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 656 participants
Deferred Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 2610 participants
Deferred Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 785 participants
Deferred Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 521 participants
Deferred Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Number of STI infections (first incidence)51 participants
Deferred Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 398 participants
Deferred Intervention ArmIncidence of STI Infection (GC, CT, Syphilis)Week 1321 participants
Comparison: Incidence rate of STIs for immediate intervention armp-value: 0.9395% CI: [23.86, 41.51]Poisson Regression
Comparison: Incidence rate of STIs for deferred intervention armp-value: 0.9395% CI: [23.92, 42.83]Poisson Regression
Comparison: Poisson regression was used to compare the incidence rate of STIs by arm.p-value: 0.9395% CI: [25.96, 38.8]Poisson Regression
Secondary

Prevalence of STI Infection (GC, CT, Syphilis) at Baseline

To determine baseline prevalence of STIs (Neisseria gonorrhoeae \[GC\], Chlamydia trachomatis \[CT\], and Treponema pallidum (syphilis)) by study arm

Time frame: 0 months

Population: Enrolled participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Immediate Intervention ArmPrevalence of STI Infection (GC, CT, Syphilis) at BaselineGonorrhea15 Participants
Immediate Intervention ArmPrevalence of STI Infection (GC, CT, Syphilis) at BaselineChlamydia Trachomatis15 Participants
Immediate Intervention ArmPrevalence of STI Infection (GC, CT, Syphilis) at BaselineSyphilis (Positive/Reactive)38 Participants
Deferred Intervention ArmPrevalence of STI Infection (GC, CT, Syphilis) at BaselineGonorrhea15 Participants
Deferred Intervention ArmPrevalence of STI Infection (GC, CT, Syphilis) at BaselineChlamydia Trachomatis15 Participants
Deferred Intervention ArmPrevalence of STI Infection (GC, CT, Syphilis) at BaselineSyphilis (Positive/Reactive)32 Participants
Comparison: Calculating the odds of Gonorrhea.p-value: 0.9195% CI: [0.45, 2.03]Regression, Logistic
Comparison: Calculating the odds of Chlamydia Trachomatis.p-value: 0.9195% CI: [0.45, 2.03]Regression, Logistic
Comparison: Calculating the odds of a syphilis positive/reactive test.p-value: 0.3295% CI: [0.45, 1.3]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026