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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04899024
Other study ID # 20200231
Secondary ID R01DA051848
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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