NCT04523519CompletedPhase 4
PrEP Intervention for People Who Inject Substances and Use Methamphetamine
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 123 (actual)
- First submitted
- 18 Aug 2020
- Start date
- 30 Apr 2021
- Primary completion date
- 22 Dec 2025
- Lead sponsor
- San Francisco Department of Public Health
- Diseases
- HIV
- NCT number
- NCT04523519
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 123
- From 30 Apr 2021 to the primary completion date, 22 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
Other illness
- Positive hepatitis B surface antigen test.
Lab values
- Creatinine clearance ≤30 mL/min, OR
Other
- Participants are excluded from the study if any of the following criteria apply:
- On PrEP for more than 6 months,
- Unwillingness to use a video app to record oneself taking PrEP, OR
- Contraindication to tenofovir or emtricitabine-containing products,
Who the study is looking for
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Age 18-65 years inclusive,
- Assigned male sex at birth,
- Past 30-day methamphetamine use on 4 or more days, by self-report,
- ≥ 1 positive methamphetamine urine toxicology,
- 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),
- Reports condomless sero-unknown/discordant anal or insertive vaginal sex with a person of any gender in the past 12 months,
- HIV-negative,
- Reliable access to a computer to complete study visits, if participating remotely, AND
- Proficient in English
Age in the registry: 18 years to 65 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Francisco Department of Public Health Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.