Actively Recruiting
PrEP Intervention for People Who Inject Substances and Use Methamphetamine
Led by San Francisco Department of Public Health · Updated on 2024-05-16
140
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
San Francisco Department of Public Health
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PrEP Intervention for People Who Inject Substances and Use Methamphetamine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years inclusive
- Assigned male sex at birth
- Methamphetamine use on 4 or more days in the past 30 days by self-report
- At least 1 positive methamphetamine urine test
- Interested in initiating PrEP or currently on daily PrEP with sub-optimal adherence (missing at least one dose in past 30 days)
- Condomless sero-unknown or discordant anal or insertive vaginal sex with a person of any gender in the past 12 months
- HIV-negative
- Reliable access to a computer for study visits if participating remotely
- Proficient in English
You will not qualify if you...
- On PrEP for more than 6 months
- Unwilling to use a video app to record taking PrEP
- Any condition that investigators believe would risk safety or prevent successful trial completion
- For participants receiving PrEP from study team: contraindication to tenofovir or emtricitabine-containing products
- Creatinine clearance less than or equal to 30 mL/min
- Positive hepatitis B surface antigen test
AI-Screening
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Trial Site Locations
Total: 1 location
1
San Francisco Department of Public Health
San Francisco, California, United States, 94102
Actively Recruiting
Research Team
P
Phillip Coffin, MD
CONTACT
V
Vanessa McMahan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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