HIV/AIDS
Conditions
Keywords
Pre-exposure prophylaxis (PrEP), Home-based monitoring
Brief summary
This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP). Individuals entering into PrEP care at an initial in-person study visit will be randomized to the PrEP@Home system for home-based PrEP care follow-up visits or to the control standard of care for clinic-based follow-up visits. The primary aim of this study is to assess protective levels of PrEP medication for the intervention arm compared to the control arm.
Detailed description
Clinical guidance calls for quarterly follow-up visits for individuals taking PrEP. Yet these visits impose burdens on the healthcare system and on patients that could hinder the persistence of patients in PrEP care. Preliminary data indicate that a home-based care system for PrEP is feasible, and acceptable, and may increase patient willingness to remain in care. This study explores the effect of a home-based PrEP support system on maintenance in PrEP care. The study will enroll 396 participants in a stratified randomized, controlled trial comparing the PrEP@Home intervention arm to the standard of care control arm. The study seeks to explore intervention performance among highly impacted groups and therefore will target a sample that is 50% Black and 50% aged 18-34 years. Individuals in the intervention and control arms will have a baseline study visit, in which patients will be prescribed PrEP. Participants randomized to the intervention arm will receive home care for PrEP at months 3, 6, 9, and 12. Home care will include a mailed package with materials for HIV/sexually transmitted infection (STI)/creatinine specimen self-collection, materials for return shipping, and a link to an electronic, self-report behavioral assessment. Home care will also include access to the intervention version of the study app to facilitate patient-provider and patient-system interactions. Study clinicians will monitor participants' in-home care, and renew prescriptions as indicated. Control arm participants will be linked to a local PrEP provider, where they will be seen for quarterly clinic visits per standard of care. Control participants will have access to the control version of the study app that contains only research elements pertinent to their participation in the control arm of the study.
Interventions
BEHAVIORALPrEP@Home System
The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP). The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects). Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed.
OTHERStandard of Care
Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP).
Sponsors
National Institute of Mental Health (NIMH)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This trial will include 396 participants with 2:1 allocation for the intervention (264) and control (132) conditions. The sample of 396 will target inclusion of 50% Black and 50% younger (aged 18-34) participants.
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Male at birth * Report anal sex with a man in the past 6 months * Are able to complete survey instruments in English * Live in the metropolitan area of a study site * Are willing to provide at least 2 means of alternate contact * Willing to not enroll in another HIV prevention trial * HIV-negative (self-reported and lab confirmed) * Own and willing to use a smartphone for the duration of the study * Willing to download the study app * Willing to take a photo of a PrEP prescription label * Behaviorally indicated for PrEP (per Centers for Disease Control and Prevention (CDC) guidance) or African American men who have sex with men (MSM) who report anal sex in the last six months * PrEP naïve or \< 3 months lifetime experience of PrEP use or stopped taking PrEP \>6 months ago * Willing to take PrEP, including adherence to daily dosing * Willing to use, as needed, study-provided PrEP navigation services to obtain coverage for PrEP medication * Able to work with the study site to develop a plan to cover the financial cost of PrEP if not covered through insurance or Gilead financial assistance * Willing to use a home kit that will include a self-administered collection of urine, rectal and pharyngeal swabs, and finger prick blood.
Exclusion criteria
* Reports having genital reassignment surgery * \<18 or ≥ 50 years of age * Currently enrolled in another HIV prevention trial * Symptoms of acute HIV infection, or being evaluated for acute infection because of recent high-risk exposure * Currently taking PEP * Creatinine clearance \<60 ml/min * Contraindications to taking tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC) * History of hemophilia * Unable to conduct finger prick at a study site * Multiple screening attempts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up | Month 6 | Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). Researchers used decision rules to determine adherence for participants who either reported using both medications in the period or did not report which medication they used. For instance, if a participant had a TFV-DP level above both cut points, they would be considered adherent to treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention in PrEP Care | Up to Month 6 | Retention in PrEP care is based on participant self-report of taking PrEP at least 4 days per week in the last week as measured at the 6 months. |
| Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 12-month Follow-up | Month 12 | Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). For participants who either reported using both medications in the period or did not report which medication they used, the researchers used decision rules to determine adherence. For instance, if a participant had a TDF-DP level above both cutpoints, they would be considered adherent to treatment. |
Countries
United States
Participant flow
Recruitment details
PrEP@Home study participants were recruited predominantly online in the study cities of Atlanta, GA, Boston, MA, Cleveland, OH, Jackson, MS, and St. Louis, MO. Participant enrollment began April 26, 2019, and all follow-up was complete by April 15, 2023. Study completion is defined as enrolled persons completing their online survey.
Participants by arm
| Arm | Count |
|---|---|
| PrEP@Home System The experimental group will be assigned to the remote care system for one year of follow-up PrEP care to include home test kits, behavioral surveillance, and telemedicine visits as needed.
PrEP@Home System: The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit has components for self-collection of urine, rectal and pharyngeal swabs, microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up (FU) visits will be done on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of emtricitabine triphosphate (FTC-TP).
The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly FU visits (sexual risk, illicit substance use, PrEP adherence, side effects).
Study Clinicians will review Lab and survey results and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as needed. | 211 |
| Standard of Care The comparator group will receive active linkage to a local PrEP provider for clinic-based PrEP follow-up. Participants in this study arm will be seen quarterly by a health care provider, per standard of care when taking PrEP.
Standard of Care: Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, emtricitabine triphosphate (FTC-TP). | 107 |
| Total | 318 |
Baseline characteristics
| Characteristic | PrEP@Home System | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 30.12 years STANDARD_DEVIATION 7.16 | 29.31 years STANDARD_DEVIATION 7.38 | 29.58 years STANDARD_DEVIATION 7.3 |
| Age, Customized Between 18-24 years | 63 Participants | 27 Participants | 90 Participants |
| Age, Customized Between 25-34 years | 105 Participants | 57 Participants | 162 Participants |
| Age, Customized Between 35-44 years | 29 Participants | 17 Participants | 46 Participants |
| Age, Customized Between 45-49 years | 14 Participants | 6 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 15 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 192 Participants | 89 Participants | 281 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 69 Participants | 29 Participants | 98 Participants |
| Race/Ethnicity, Customized More than one race | 11 Participants | 9 Participants | 20 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander/Asian | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 4 Participants | 9 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 119 Participants | 53 Participants | 172 Participants |
| Region of Enrollment United States | 211 participants | 107 participants | 318 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 211 Participants | 107 Participants | 318 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 211 | 0 / 107 |
| other Total, other adverse events | 7 / 211 | 1 / 107 |
| serious Total, serious adverse events | 0 / 211 | 0 / 107 |
Outcome results
Primary
Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up
Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). Researchers used decision rules to determine adherence for participants who either reported using both medications in the period or did not report which medication they used. For instance, if a participant had a TFV-DP level above both cut points, they would be considered adherent to treatment.
Time frame: Month 6
Population: This analysis includes participants who submitted a dry blood spot card that had an adequate size of the blood sample for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP@Home System | Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up | 78 Participants |
| Standard of Care | Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up | 39 Participants |
Secondary
Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 12-month Follow-up
Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week). For participants who either reported using both medications in the period or did not report which medication they used, the researchers used decision rules to determine adherence. For instance, if a participant had a TDF-DP level above both cutpoints, they would be considered adherent to treatment.
Time frame: Month 12
Population: This analysis includes participants who submitted a dry blood spot card that had an adequate size of the blood sample for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP@Home System | Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 12-month Follow-up | 56 Participants |
| Standard of Care | Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 12-month Follow-up | 36 Participants |
Secondary
Retention in PrEP Care
Retention in PrEP care is based on participant self-report of taking PrEP at least 4 days per week in the last week as measured at the 6 months.
Time frame: Up to Month 6
Population: Participants with self-report data indicating adherent daily PrEP dosing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP@Home System | Retention in PrEP Care | 132 Participants |
| Standard of Care | Retention in PrEP Care | 55 Participants |