PrEP Affect Regulation Treatment Innovation
- Conditions
- HIV PreventionStimulant UseMedication Adherence
- Interventions
- Behavioral: PARTIBehavioral: Attention-ControlBehavioral: Contingency Management for PrEP 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 239
- 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
- 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
- Arm && Interventions
Group Intervention Description PARTI and CM (Contingency Management) PARTI The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence PARTI and CM (Contingency Management) Contingency Management for PrEP Adherence The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence Attention-Control and CM (Contingency Management) Attention-Control The attention-control condition will consist of five individual sessions where participants complete self-report measures and neutral writing exercises during a 12-week contingency management protocol for PrEP adherence Attention-Control and CM (Contingency Management) Contingency Management for PrEP Adherence The attention-control condition will consist of five individual sessions where participants complete self-report measures and neutral writing exercises during a 12-week contingency management protocol for PrEP adherence
- 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