Using video therapy to improve PrEP adherence for men who inject methamphetamine

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

This study is testing if using video therapy with rewards can help men who inject methamphetamine stick to their HIV prevention medication better than just counseling alone.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Male
• Sponsor: San Francisco Department of Public Health (Government)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT04523519 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of video directly observed therapy with contingency management (VDOT-CM) in improving adherence to pre-exposure prophylaxis (PrEP) among HIV-negative men assigned male sex at birth who inject methamphetamine. A total of 140 participants will be randomized to receive either VDOT-CM or counseling alone over a 24-week period. The study aims to assess both the efficacy of VDOT-CM in enhancing PrEP adherence and the acceptability of PrEP among the participants. Additionally, it will explore changes in injection and sexual risk behaviors during the study period.

Who should consider this trial

Good fit: Ideal candidates are HIV-negative men assigned male sex at birth, aged 18-65, who have recently used methamphetamine and engaged in sexual risk behaviors.

Not a fit: Patients who have been on PrEP for more than 6 months or are unwilling to use a video app for therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve PrEP adherence among high-risk populations, thereby reducing new HIV infections.

How similar studies have performed: While there have been few studies focusing on PrEP adherence among people who inject drugs, similar approaches have shown promise in other populations, making this a potentially impactful intervention.

Eligibility criteria

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.

Where this trial is running

San Francisco, California

• San Francisco Department of Public Health — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Phillip Coffin — San Francisco Department of Public Health
• Study coordinator: Phillip Coffin, MD

Conditions HIV Infections