PrEP Affect Regulation Treatment Innovation

Not Applicable

Active, not recruiting

• Conditions: HIV Prevention; Stimulant Use; Medication Adherence

• Registration Number: NCT04899024
• Lead Sponsor: Florida International University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Study Start: 2022-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-02-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 239

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Engaging HIV Acquisition Risk	Up to 12 months	Percentage of participants engaging in HIV acquisition risk (i.e., defined as tenofovir - diphosphate levels \< 700 fmol per punch from dried blood spots and any self-reported recent condomless anal sex)

Secondary Outcome Measures

Name	Time	Method
PrEP Persistence	Up to 12 months	Percentage of participants who continue taking PrEP medication
Self-Reported Stimulant Use Severity	Up to 12 months	The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) provides validated composite scores indexing the severity of cocaine and amphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).
Positive Affect	Up to 12 months	Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect.
Retention in PrEP Care	Up to 12 months	Percentage of participants who report attending a medical visit with the PrEP provider in the past three months

Trial Locations

Locations (2)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States