Status:
RECRUITING
PrEP Intervention for People Who Inject Substances and Use Methamphetamine
Lead Sponsor:
San Francisco Department of Public Health
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Eligibility:
MALE
18-65 years
Phase:
PHASE4
Brief 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...
Detailed 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 di...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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:
- Contraindication to tenofovir or emtricitabine-containing products,
- Creatinine clearance ≤30 mL/min, OR
- Positive hepatitis B surface antigen test.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04523519
Start Date
April 30 2021
End Date
May 1 2025
Last Update
May 16 2024
Active Locations (1)
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1
San Francisco Department of Public Health
San Francisco, California, United States, 94102