PrEP Intervention for People Who Inject Substances and Use Methamphetamine

Description

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

HIV Infections

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Study Overview

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Study Details

Study overview

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.

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

Condition
HIV Infections
Intervention / Treatment

-

Contacts and Locations

San Francisco

San Francisco Department of Public Health, San Francisco, California, United States, 94102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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.
  • 4. Contraindication to tenofovir or emtricitabine-containing products,
  • 5. Creatinine clearance ≤30 mL/min, OR
  • 6. Positive hepatitis B surface antigen test.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

San Francisco Department of Public Health,

Phillip Coffin, PRINCIPAL_INVESTIGATOR, San Francisco Department of Public Health

Study Record Dates

2025-05