PrEP Affect Regulation Treatment Innovation

Medication Adherence Clinical Trial

— PARTI  

Official title:

Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899024
• Other study ID #: 20200231
• Secondary ID: R01DA051848
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: November 2023
• Source: Florida International University
• Contact: Adam W. Carrico, PhD
• Phone: 305-348-7887
• Email: acarrico[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention
• Medication Adherence
• Stimulant Use

Intervention

Behavioral:
• PARTI
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.
• Attention-Control
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.
• Contingency Management for PrEP Adherence
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.

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Florida International University	National Institute on Drug Abuse (NIDA), University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PrEP Persistence	Percentage of participants who continue taking PrEP medication	Up to 12 months
Secondary	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
Secondary	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
Secondary	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