Summary

Eligibility
for males ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

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
  • Past 6 months, reports condomless anal sex (CAS) with men
  • HIV negative
  • Currently has an active prescription for daily oral PrEP and reports any non-adherence in the past month
  • 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)
  • Lives within catchment area (South Florida, San Francisco Bay area)

You CAN'T join if...

  • Unable to provide informed consent
  • Unwilling to participate in smartphone-based CM for directly observed PrEP doses
  • Unwilling to provide dried blood spot (DBS) specimen
  • Plans to move out of the state in the next 6 months
  • Not taking PrEP daily (e.g., if taking intermittent 2-1-1 dosing)
  • Switched from Truvada to Descovy in the last 5 months

Locations

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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Miami
ID
NCT04899024
Study Type
Interventional
Last Updated