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PrEP Affect Regulation Treatment Innovation (PARTI)

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ClinicalTrials.gov Identifier: NCT04899024
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : May 9, 2022
Sponsor:
Collaborators:
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Adam Carrico, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Medication Adherence HIV Prevention Stimulant Use Behavioral: PARTI Behavioral: Attention-Control Behavioral: Contingency Management for PrEP Adherence Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants
Actual Study Start Date : January 31, 2022
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : July 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: PARTI and CM (Contingency Management)
The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence
 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.

Behavioral: 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.
Active Comparator: Attention-Control and CM (Contingency Management)
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
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.

Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Engaging HIV Acquisition Risk [ Time Frame: 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 :
  1. PrEP Persistence [ Time Frame: Up to 12 months ]
    Percentage of participants who continue taking PrEP medication

  2. Retention in PrEP Care [ Time Frame: Up to 12 months ]
    Percentage of participants who report attending a medical visit with the PrEP provider in the past three months

  3. Self-Reported Stimulant Use Severity [ Time Frame: 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).

  4. Positive Affect [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Assigned male at birth
  • Identifies as male
  • 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 and reports any non-adherence in the past month
  • 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)
  • Lives within catchment area (South Florida, San Francisco Bay area)

Exclusion Criteria:

  • Unable to provide informed consent
  • Unwilling to participate in smartphone-based CM for directly observed PrEP doses
  • Unwilling to provide dried blood spot (DBS) specimen
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04899024


Contacts
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Contact: Adam W. Carrico, PhD 305-243-6947 a.carrico@miami.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Lara Coffin, MPH    415-502-5216    Lara.Coffin@ucsf.edu   
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Chelsea Henderson    954-802-9318    cxv446@miami.edu   
Contact: Omar Valentin    787-565-1444    orv5@med.miami.edu   
Sponsors and Collaborators
University of Miami
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Adam W Carrico, PhD University of Miami
More Information
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Responsible Party: Adam Carrico, Professor, Director, University of Miami
ClinicalTrials.gov Identifier: NCT04899024    
Other Study ID Numbers: 20200231
R01DA051848 ( U.S. NIH Grant/Contract )
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adam Carrico, University of Miami:
Sexual Minority Men
HIV
PrEP Adherence
Contingency Management