HIV
Conditions
Keywords
Text Messaging, mHealth, HIV, AIDS, PrEP
Brief summary
TechStep is a three-arm, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative transgender feminine, transgender masculine, and gender non-conforming youth and young adults for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake. Participants are randomized into one of three conditions for a 6-month intervention: Group 1: culturally relevant theory-based text messages (Text+Step); or, Group 2: culturally relevant mobile-enhanced website (WebApp+Step); or, Group 3: informational website control condition with no theoretically based text messages or WebApp.
Detailed description
TechStep is a three-arm, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative transgender feminine, transgender masculine, and gender non-conforming youth and young adults for reducing sexual risk behaviors and increasing PrEP uptake. Transgender youth and young adults are enrolled for 9 months in the RCT. During the RCT, 250 participants will be enrolled and randomized to either: (1) text messaging (n=83), (2) WebApp (n=83), or (3) an informational website control (n=83) condition. Participants will include HIV-negative youth and young adults (ages 15-24) who are self-identified transgender feminine, transgender masculine or gender non-conforming. Participants will be recruited from venues in Boston, Houston, Los Angeles, New York, and Philadelphia. There will be four data collection time points: baseline, 3-, 6-, and 9-month. Visits will be conducted in-person at the venues, online, or some combination of in person or online. An ACASI will be completed using online survey tools. An HIV test, sexually transmitted infection (STI) panel, urine screen for recent illicit drug use, and blood microsampling or dried blood spot, for those who report PrEP uptake, to verify PrEP adherence will be collected in-person at the participants local venue, or via mailed self-collection kits. Process data of each participant activity at each step of the intervention, as well as the control intervention, will be collected. The study aims to measure the effects of the information-only (Info) arm compared to a text messaging intervention (Text+Step) to a WebApp intervention (WebApp+Step) for reducing sexual risk behaviors and increasing PrEP uptake.
Interventions
BEHAVIORALText Messaging (Text+Step)
Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
BEHAVIORALWebApp (App+Step)
Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
BEHAVIORALInformation/No Step
Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Sponsors
San Diego State University
University of North Carolina
Emory University
Baylor College of Medicine
Children's Hospital of Philadelphia
The Fenway Institute
Hunter College of City University of New York
Children's Hospital Los Angeles
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Report vaginal or anal sex (either insertive or receptive; excluding sex toys) with another person in the previous 12 months; * Confirmed negative HIV test; * Availability to meet with research staff in person or online at either the Baylor College of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, the PRIDE Health Research Consortium in New York City, or the Fenway Institute in Boston * Have a mobile device with short messaging service (SMS; i.e. texting) and Internet access capabilities; and * Read and speak English (since the intervention is built in English)
Exclusion criteria
* Does not report vaginal or anal sex (either insertive or receptive; excluding sex toys) with another person in the previous 12 months; * Reactive or indeterminate HIV test; * Unable to meet with research staff in person or online at either the Baylor College of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, the PRIDE Health Research Consortium in New York City, or the Fenway Institute in Boston * Does not have a mobile device with SMS and Internet access capabilities; * Unable to read and speak English (since the intervention is built and delivered in English) * Unwilling or unable to comply with protocol requirements; * Unable to understand the Informed Consent/Assent Form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Condomless Intercourse Events | 9 Months | Participants will report the frequency of condomless sexual intercourse events they have engaged in for the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up. |
| Condomless Intercourse Events While High on Drugs/Alcohol | 9 Months | Participants will report the number of condomless sexual intercourse events they have engaged in while high on drugs or alcohol during their three most recent sexual encounters in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up. |
| Condomless Intercourse Events During Sex Work | 9 Months | Participants will report the number of exchange partners in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up. |
| HIV Seroconversion | 9 Months | HIV tests will be collected at each time point. Incident infections will be recorded. |
| Incident STIs | 9 Months | Participants will be tested for gonorrhea and chlamydia via throat, rectal, and urogenital swab specimen collection, as well as via urine samples at each time point. Incident STIs will be recorded. |
Countries
United States
Participant flow
Pre-assignment details
A confirmed negative HIV test was required to enroll in the study. Participants who used a remote enrollment option were offered at-home STI testing which included an HIV test. Participants who did not return at least the HIV test portion of the kit were subsequently and retroactively ineligible for the study, withdrawn, and not considered randomized.
Participants by arm
| Arm | Count |
|---|---|
| Text+Step The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. | 82 |
| WebApp+Step The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. | 87 |
| Information The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons. | 85 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 7 | 13 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 4 |
Baseline characteristics
| Characteristic | Text+Step | WebApp+Step | Information | Total |
|---|---|---|---|---|
| Age, Continuous | 20.88 years STANDARD_DEVIATION 2.08 | 21.21 years STANDARD_DEVIATION 1.87 | 21.57 years STANDARD_DEVIATION 1.83 | 21.22 years STANDARD_DEVIATION 1.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 20 Participants | 20 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 66 Participants | 63 Participants | 189 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 11 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 7 Participants | 4 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 15 Participants | 14 Participants | 45 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) White | 46 Participants | 51 Participants | 47 Participants | 144 Participants |
| Region of Enrollment United States | 82 participants | 87 participants | 85 participants | 254 participants |
| Sex/Gender, Customized nonbinary (assigned female at birth) | 39 Participants | 40 Participants | 34 Participants | 113 Participants |
| Sex/Gender, Customized nonbinary (assigned male at birth) | 13 Participants | 7 Participants | 13 Participants | 33 Participants |
| Sex/Gender, Customized trans feminine | 5 Participants | 7 Participants | 8 Participants | 20 Participants |
| Sex/Gender, Customized trans masculine | 25 Participants | 33 Participants | 30 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 82 | 0 / 87 |
| other Total, other adverse events | 2 / 85 | 1 / 82 | 3 / 87 |
| serious Total, serious adverse events | 0 / 85 | 0 / 82 | 0 / 87 |
Outcome results
Primary
Condomless Intercourse Events
Participants will report the frequency of condomless sexual intercourse events they have engaged in for the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
Time frame: 9 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Text+Step | Condomless Intercourse Events | 3.14 Expected events |
| WebApp+Step | Condomless Intercourse Events | 3.17 Expected events |
| Information | Condomless Intercourse Events | 3.68 Expected events |
p-value: 0.14195% CI: [-1.26, 0.18]Longitudinal Targeted Maximum Likelihood
p-value: 0.12395% CI: [-1.16, 0.14]Longitudinal Targeted Maximum Likelihood
Primary
Condomless Intercourse Events During Sex Work
Participants will report the number of exchange partners in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
Time frame: 9 Months
Population: Participants who answered the relevant survey questions necessary to assess the 3-month step-up criteria were included in the analytical sample.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Text+Step | Condomless Intercourse Events During Sex Work | 0 Expected events |
| WebApp+Step | Condomless Intercourse Events During Sex Work | 0.03 Expected events |
| Information | Condomless Intercourse Events During Sex Work | 0 Expected events |
Primary
Condomless Intercourse Events While High on Drugs/Alcohol
Participants will report the number of condomless sexual intercourse events they have engaged in while high on drugs or alcohol during their three most recent sexual encounters in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
Time frame: 9 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Text+Step | Condomless Intercourse Events While High on Drugs/Alcohol | 1.04 Expected events |
| WebApp+Step | Condomless Intercourse Events While High on Drugs/Alcohol | 0.79 Expected events |
| Information | Condomless Intercourse Events While High on Drugs/Alcohol | 1.02 Expected events |
p-value: 0.12795% CI: [-0.56, 0.07]Longitudinal Targeted Maximum Likelihood
p-value: 0.89995% CI: [-0.34, 0.3]Longitudinal Targeted Maximum Likelihood
Primary
HIV Seroconversion
HIV tests will be collected at each time point. Incident infections will be recorded.
Time frame: 9 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text+Step | HIV Seroconversion | 0 Participants |
| WebApp+Step | HIV Seroconversion | 0 Participants |
| Information | HIV Seroconversion | 0 Participants |
Primary
Incident STIs
Participants will be tested for gonorrhea and chlamydia via throat, rectal, and urogenital swab specimen collection, as well as via urine samples at each time point. Incident STIs will be recorded.
Time frame: 9 Months
Population: Participants who answered the relevant survey questions necessary to assess the 3-month step-up criteria were included in the analytical sample.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Text+Step | Incident STIs | 0.06 Expected infections |
| WebApp+Step | Incident STIs | 0.02 Expected infections |
| Information | Incident STIs | 0.04 Expected infections |