RECRUITINGPhase 4INTERVENTIONAL

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

About This Trial

In this study, "PrEP Intervention for people who Inject Substances and Use Methamphetamine" (PRIME), we propose to assess if using video directly observed therapy with real-time contingency management (VDOT-CM) may help people assigned male sex at birth who inject methamphetamine adhere to PrEP. We will randomize 140 adults who use methamphetamine, are HIV-negative, and have recently engaged in a sexual HIV risk behavior to VDOT-CM or counseling alone for 24 weeks. The study aims are to (1) determine the efficacy of VDOT-CM compared to counseling alone for PrEP adherence, (2) evaluate the acceptability of PrEP and adherence support strategies among the cohort, and (3) compare injection or chemsex and sexual HIV risk behavior before and during PrEP use. We hypothesize that participants randomized to VDOT-CM will have superior adherence to PrEP. We also hypothesize that participants will describe barriers to and facilitators of PrEP adherence, and those who are randomized to VDOT-CM will consider it an acceptable PrEP adherence support strategy. Finally, we do not expect to find increased injection, chemsex, or sexual risk behaviors for HIV among study participants after they begin taking PrEP.

Who May Be Eligible (Plain English)

Who May Qualify: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Age 18-65 years inclusive, 2. Assigned male sex at birth, 3. Past 30-day methamphetamine use on 4 or more days, by self-report, 4. ≥ 1 positive methamphetamine urine toxicology, 5. Either interested in initiating PrEP OR currently on daily PrEP with sub-optimal adherence (measured as missing at least one dose of one's PrEP in the past 30 days, by self-report), 6. Reports condomless sero-unknown/discordant anal or insertive vaginal sex with a person of any gender in the past 12 months, 7. HIV-negative, 8. Reliable access to a computer to complete study visits, if participating remotely, AND 9. Proficient in English Who Should NOT Join This Trial: Participants are excluded from the study if any of the following criteria apply: 1. On PrEP for more than 6 months, 2. Unwillingness to use a video app to record oneself taking PrEP, OR 3. Any other circumstances that, in the opinion of the investigators, would compromise participant safety and/or successful completion of the trial. For participants receiving PrEP from the study team, exclusion criteria will include the following: 4. Contraindication to tenofovir or emtricitabine-containing products, 5. Creatinine clearance ≤30 mL/min, OR 6. Positive hepatitis B surface antigen test. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Age 18-65 years inclusive, 2. Assigned male sex at birth, 3. Past 30-day methamphetamine use on 4 or more days, by self-report, 4. ≥ 1 positive methamphetamine urine toxicology, 5. Either interested in initiating PrEP OR currently on daily PrEP with sub-optimal adherence (measured as missing at least one dose of one's PrEP in the past 30 days, by self-report), 6. Reports condomless sero-unknown/discordant anal or insertive vaginal sex with a person of any gender in the past 12 months, 7. HIV-negative, 8. Reliable access to a computer to complete study visits, if participating remotely, AND 9. Proficient in English Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. On PrEP for more than 6 months, 2. Unwillingness to use a video app to record oneself taking PrEP, OR 3. Any other circumstances that, in the opinion of the investigators, would compromise participant safety and/or successful completion of the trial. For participants receiving PrEP from the study team, exclusion criteria will include the following: 4. Contraindication to tenofovir or emtricitabine-containing products, 5. Creatinine clearance ≤30 mL/min, OR 6. Positive hepatitis B surface antigen test.

Treatments Being Tested

BEHAVIORAL

Video directly observed therapy with contingency management

PrEP adherence will be assessed by visual recognition software during video capture and reviewed for confirmation by study staff, ensuring that videos demonstrate study medication dosing by participant. Participants will receive small financial incentives upon confirmation of dosing.

BEHAVIORAL

Integrated Next-Step Counseling

Integrated Next-Step Counseling combines support for behavioral strategies that reduce sexual and injection-related HIV risk and do not involve PrEP, with strategies to support PrEP adherence in brief, client-centered conversations.

Locations (1)

San Francisco Department of Public Health

San Francisco, California, United States