Clinical trial NCT04899024: PrEP Affect Regulation Treatment Innovation
Official title: Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Medication Adherence
HIV Prevention
Stimulant Use
Keywords: Sexual Minority Men
HIV
PrEP Adherence
Contingency Management
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-05-24
Enrollment: 239
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Engaging HIV Acquisition Risk
timeFrame: Up to 12 months
Secondary outcomes:
measure: PrEP Persistence
timeFrame: Up to 12 months
measure: Retention in PrEP Care
timeFrame: Up to 12 months
measure: Self-Reported Stimulant Use Severity
timeFrame: Up to 12 months
measure: Positive Affect
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: Florida International University
name: Adam W Carrico, PhD
role: PRINCIPAL_INVESTIGATOR
References: