RecruitingPhase 4NCT04523519

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

Sponsor

San Francisco Department of Public Health

Enrollment

140 participants

Start Date

Apr 30, 2021

Study Type

INTERVENTIONAL

Conditions

HIV Infections

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether PrEP (pre-exposure prophylaxis — a daily pill that prevents HIV infection) can be successfully started or improved among men who inject drugs and use methamphetamine, combining HIV prevention with addiction support. **You may be eligible if...** - You are between 18 and 65 years old - You were assigned male sex at birth - You have used methamphetamine on 4 or more days in the past 30 days - You have a positive urine test for methamphetamine - You are either interested in starting PrEP or currently taking PrEP but missing doses **You may NOT be eligible if...** - You are already on PrEP with excellent adherence - You are HIV-positive - You have significant kidney problems that would make PrEP unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.