PrEP Intervention for People Who Inject Substances and Use Methamphetamine
San Francisco Department of Public Health
Summary
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.
Description
New HIV infections among people who inject drugs (PWID) are increasing in the United States and San Francisco. Methamphetamine is a driving force in the transmission of HIV. Multiple studies across diverse populations have found methamphetamine use to be independently associated with both injection and sexual risk behaviors for HIV acquisition. Men who have sex with men (MSM) who inject methamphetamine are at particularly elevated risk for HIV from both injection and sexual risk behaviors. Daily, oral pre-exposure prophylaxis (PrEP) is safe and highly effective for HIV prevention when taken c…
Eligibility
- Age range
- 18–65 years
- Sex
- Male
- Healthy volunteers
- Yes
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 pa…
Interventions
- BehavioralVideo 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.
- BehavioralIntegrated 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.
Location
- San Francisco Department of Public HealthSan Francisco, California