This study is in progress, not accepting new patients

PrEP Affect Regulation Treatment Innovation

a study on Treatment Adherence HIV/AIDS Stimulant Use PrEP

Summary

Eligibility
for males ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around

Description

Summary

This multi-site randomized controlled trial enrolling sexual minority men who use stimulants and are currently taking pre-exposure prophylaxis (PrEP). This randomized controlled trial will test the efficacy of a PrEP Affect Regulation Treatment Innovation (PARTI) condition comprised of a 5-session positive affect intervention delivered during smartphone-based Contingency Management (CM) for directly observed PrEP doses (PARTI+CM) compared to an attention-control condition delivered during CM. The primary outcome is HIV acquisition risk measured using a combination of tenofovir-diphosphate levels in dried blood spots that are indicative of sub-optimal adherence to PrEP and recent condomless anal sex.

Official Title

Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants

Keywords

Medication Adherence, HIV Prevention, Stimulant Use, Sexual Minority Men, HIV, PrEP Adherence, Contingency Management, PARTI, Contingency Management for PrEP Adherence, PARTI and CM (Contingency Management)

Eligibility

You can join if…

Open to males ages 18 years and up

  • Assigned male at birth
  • Identifies as male
  • Age 18 or older
  • Reads and speaks English
  • Reports condomless anal sex (CAS) with men in the past 6 months
  • self-reported HIV negative
  • Active prescription for daily oral PrEP for at least 2 months and reports any non-adherence in the past month OR initiated daily oral PrEP in the past 2 months, regardless of self-reported adherence
  • Has an iPhone or Android smartphone
  • Screens positive for a moderate or severe stimulant use disorder with an abbreviated version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST; total score of 4 or more) OR reports using stimulants at least weekly in the past 3 months.
  • Lives in California or Florida with no plans to move out of state in the next 6 months

You CAN'T join if...

  • Unable or unwilling to provide informed consent
  • Unwilling to upload upload 3 video recordings of directly observed PrEP doses using a smartphone application
  • Identifies as transfeminine (e.g., transgender woman)
  • Unable or Unwilling to provide dried blood spot (DBS) specimen at baseline
  • Switched from daily oral PrEP with disoproxil fumarate (TDF) to daily oral PrEP with tenofovir alafenamide (TAF) in the past 5 months

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • University of Miami Miller School of Medicine
    Miami Florida 33136 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Florida International University
ID
NCT04899024
Study Type
Interventional
Participants
About 239 people participating
Last Updated