PrEP Intervention for People Who Inject Substances and Use Methamphetamine

Who is this study for? Patients with Human Immunodeficiency Virus
What treatments are being studied? Integrated Next-Step Counseling
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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⁃ 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

Locations
United States
California
San Francisco Department of Public Health
RECRUITING
San Francisco
Contact Information
Primary
Phillip Coffin, MD
phillip.coffin@sfdph.org
628-217-6282
Backup
Vanessa McMahan, PhD
vanessa.mcmahan@sfdph.org
628-217-7469
Time Frame
Start Date: 2021-04-30
Estimated Completion Date: 2025-05
Participants
Target number of participants: 140
Treatments
Experimental: Video directly observed therapy with contingency management
Video directly observed therapy with contingency management, in addition to Integrated Next-Step Counseling.
Placebo_comparator: Integrated Next-Step Counseling
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: San Francisco Department of Public Health

This content was sourced from clinicaltrials.gov