PrEP Affect Regulation Treatment Innovation

Study Overview
=================
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.

Official Title
-----------------
Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants

Conditions
-----------------
HIV Prevention, Medication Adherence, Stimulant Use

Intervention / Treatment
-----------------
* Behavioral: PARTI
* Behavioral: Attention-Control
* Behavioral: Contingency Management for PrEP Adherence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Assigned male at birth Identifies as male or gender non-conforming 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 for at least 2 months and reports any non-adherence in the past month OR was initiated on PrEP in the past 2 months, regardless of 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 weekly use of either methamphetamine or cocaine. Lives in California or Florida Exclusion Criteria: Unable to provide informed consent Unwilling to participate in smartphone-based CM for directly observed PrEP doses Identifies as transfeminine (e.g., transgender woman) Assigned female at birth Unwilling to provide dried blood spot (DBS) specimen - either in-person or remotely 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PARTI and CM (Contingency Management)<br>The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence | Behavioral: PARTI<br>* PARTI will provide positive affect skills. Each 1-hour session delivered via Zoom consists of a didactic portion with in vivo skills practice and participants are asked to complete home practice of the skills between sessions. Many sessions include formal exercises that have been utilized in Mindfulness-Based Relapse Prevention to cultivate mindfulness and meta-cognitive awareness.<br>Behavioral: Contingency Management for PrEP Adherence<br>* Participants will complete a 12-week contingency management protocol via their smartphone that consists of uploading brief videos taking PrEP medications up to four times per week. Total possible contingency management incentive for completing 48 observed PrEP doses is $360.<br>|
| Active Comparator: Attention-Control and CM (Contingency Management)<br>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 | Behavioral: Attention-Control<br>* Attention-Control will provide a core set of coping and affect measures as well as neutral writing exercises. Each 1-hour attention-control session will be administered via Zoom.<br>Behavioral: Contingency Management for PrEP Adherence<br>* Participants will complete a 12-week contingency management protocol via their smartphone that consists of uploading brief videos taking PrEP medications up to four times per week. Total possible contingency management incentive for completing 48 observed PrEP doses is $360.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Engaging HIV Acquisition Risk | 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) | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Persistence | Percentage of participants who continue taking PrEP medication | Up to 12 months | 
| Retention in PrEP Care | Percentage of participants who report attending a medical visit with the PrEP provider in the past three months | Up to 12 months | 
| Self-Reported Stimulant Use Severity | 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). | Up to 12 months | 
| Positive Affect | Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect. | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sexual Minority Men, HIV, PrEP Adherence, Contingency Management