Pre-exposure prophylaxis (PrEP) is a pill or a shot that can prevent HIV infection. Doxycycline is an antibiotic that, when taken after sex (post-exposure prophylaxis or PEP), can prevent gonorrhea, chlamydia, and syphilis. The PrEP Choice study (maybe called Proxy for “PrEP” and “Doxy”) is asking 2 questions: 1) Does a package of mobile health tools help young gay and bisexual men who have sex with men to choose which type of PrEP to take and to take it as recommended? And 2) When offered doxycycline PEP, who will take it and will they take it as recommended? This research is important because rates of HIV infection and sexually transmitted infections are very high in young gay and bisexual men who have sex with men. We hope to be able to break the cycle of infections by using these highly effective medications to prevent HIV and sexually transmitted infections.ts:
Study Purpose:
The overarching goal of this project is to assess the efficacy and cost of the integrated PrEP Choice tool on PrEP initiation and adherence among young gay, bisexual, and other men who have sex with men (YGBMSM).
Study Design:
Focus Group: There will be 4 iterative focus groups (2 English, 2 Spanish) to elicit preferences on the usability and functionality of the full PrEP Choice package, making modifications to the package based on sequential feedback.
Technical Pilot: A 3-month technical pilot study will be conducted in 20 YGBMSM, including at least 10 Spanish-speaking youth, to optimize functionality and technical performance of PrEP Choice, and to optimize and operationalize its use for the randomized controlled trial.
Randomized Control Trial (RCT): This is an individual-level randomized trial with a wait-list control and provides PrEP for study participants at the study site consortia. Participants will be randomly assigned to either receive the PrEP Choice package or a control (paper brochure describing PrEP options and standard of care counseling) for the first 9 months.
Study Population:
Participants for the iterative focus groups must meet the following criteria:
Inclusion Criteria:
- Age 13-24 years
- Cisgender-male
- Reports anal or vaginal/front-hole sex with a cis-gender man or transgender women in the past 6 months
- Willing and able to provide written informed consent
- HIV-uninfected by self-report
- Owns an iOS or Android mobile phone
- Able to understand, read, and speak English or Spanish
- On PrEP or interested in starting PrEP
Exclusion Criteria:
- Any health condition that may interfere with participation or the ability to provide informed consent
- Employee of the study site
Participants for the technical pilot and RCT must meet the following criteria:
Inclusion Criteria:
- Age 13-24 years
- Cisgender-male
- Reports anal or vaginal/front-hole sex with a cis-gender man or transgender women in the past 6 months
- Willing and able to provide written informed consent
- Owns an iOS or Android mobile phone and able to access all elements of the PrEP Choice package
- HIV negative within 28 days of enrollment
- Creatinine clearance > 60 ml/min
- Hepatitis B surface antigen negative
- Able to understand, read, and speak English or Spanish
- Weighs at least 77lbs
- Not currently on PrEP and interested in learning more about PrEP
Exclusion Criteria:
- Any health condition that may interfere with participation or the ability to provide informed consent
- Currently participating in an interventional trial of PrEP agents, or prior enrollment in HPTN 083 or HPTN 083-01;
- In a mutually monogamous sexual relationship with an HIV-negative partner for the past 12 months
- Any medical, psychiatric, or social condition that in the opinion of the investigator would preclude participation or their ability to remain in the trial for a 3-month period (technical pilot) or an 18-month period (RCT)
- Plan to move away from the site within 3 months (technical pilot) or 18 month (RCT)
- Employee of the study site
Study Size:
The PrEP Choice iterative focus groups will take place in 4 groups of 6-8 people (total 24-32), 2 in English and 2 in Spanish, with up to 3 meetings. The PrEP Choice technical pilot will be conducted in 20 participants, followed for 3 months, all receiving the PrEP Choice package. The PrEP Choice RCT will be conducted in 200 participants, followed for 18 months, with at least 25% each Black, Latinx and 13–19-year-old participants.
Study Duration:
TBD
Treatment Regimen:
- For daily oral PrEP with TDF/FTC, adherence will be measured at quarterly visits as the presence of tenofovir diphosphate (TFV-DP) of >700 fmol/punch on DBS (consistent with taking PrEP 4 or more days per week in the previous month).
- For daily oral PrEP with TAF/FTC, adherence will be measured at quarterly visits as the presence of TFV-DP in DBS of >950 fmol/punch (consistent with taking PrEP 4 or more days per week in the previous month).
- For 2-1-1 PrEP, we will use the approach of the IPERGAY investigators who estimated on-demand tablet intake in the preceding 30 days based upon TFV-DP category. 85 For example, the expected TFV-DP from one encounter in the preceding month (4 TDF/FTC doses) would be >200 but <350 fmol/punch. The expected concentrations for 3 encounters (12 doses) would be >600 but <800 fmol/punch. These relationships were determined from directly observed dosing studies. 86 Participants will be asked about the number of anal/vaginal sex encounters in the past 30 days.
- For CAB-LA, adherence will be measured by administration of CAB-LA every 8 weeks, within 28 days of the expected dosing.
Primary Objectives:
The primary endpoints are PrEP uptake and PrEP adherence over time with any of 4 different PrEP regimens: daily TDF/FTC, daily TAF/FTC, 2-1-1 PrEP with TDF/FTC, and CAB-LA. Comparisons will be made between PrEP uptake in those with access to PrEP Choice vs. control arm over time, based on treatment assignment. PrEP uptake will be measured by dispensing of oral or administration of injectable medication.
Secondary Objectives:
Participants will be asked about PrEP coverage of sex acts in the past month by CASI as a secondary outcome measure, and CAB-LA users will have DBS collected and stored for exploratory analyses (e.g. analysis of CAB drug concentrations in seroconverters).
Participating Sites
TBD
Team Members
Susan Buchbinder, MD
Protocol Chair
San Francisco Department of Public Health
Albert Liu, MD, MPH
Protocol Co-Chair
San Francisco Department of Public Health
Victoria Miller, PhD
The Children’s Hospital of Philadelphia
Dominika Seidman, MD, MAS
University of California San Francisco
Hyman Scott
San Francisco Department of Public Health
Kate Muessig, PhD
Florida State University
Hira Qadir
Westat