RECRUITING

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

Quick Facts

Study Start:2021-04-30
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04523519

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-65 years inclusive,
  2. 2. Assigned male sex at birth,
  3. 3. Past 30-day methamphetamine use on 4 or more days, by self-report,
  4. 4. ≥ 1 positive methamphetamine urine toxicology,
  5. 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. 6. Reports condomless sero-unknown/discordant anal or insertive vaginal sex with a person of any gender in the past 12 months,
  7. 7. HIV-negative,
  8. 8. Reliable access to a computer to complete study visits, if participating remotely, AND
  9. 9. Proficient in English
  1. 1. On PrEP for more than 6 months,
  2. 2. Unwillingness to use a video app to record oneself taking PrEP, OR
  3. 3. Any other circumstances that, in the opinion of the investigators, would compromise participant safety and/or successful completion of the trial.
  4. 4. Contraindication to tenofovir or emtricitabine-containing products,
  5. 5. Creatinine clearance ≤30 mL/min, OR
  6. 6. Positive hepatitis B surface antigen test.

Contacts and Locations

Study Contact

Phillip Coffin, MD
CONTACT
628-217-6282
phillip.coffin@sfdph.org
Vanessa McMahan, PhD
CONTACT
628-217-7469
vanessa.mcmahan@sfdph.org

Principal Investigator

Phillip Coffin
PRINCIPAL_INVESTIGATOR
San Francisco Department of Public Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: San Francisco Department of Public Health

  • Phillip Coffin, PRINCIPAL_INVESTIGATOR, San Francisco Department of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-30
Study Completion Date2025-05

Study Record Updates

Study Start Date2021-04-30
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

  • HIV Infections