PrEP Affect Regulation Treatment Innovation (PARTI)

Florida International University (FIU)

Status: Active, not recruiting

Conditions: Medication Adherence; Stimulant Use; HIV Prevention

Treatments: Behavioral: Attention-Control; Behavioral: Contingency Management for PrEP Adherence; Behavioral: PARTI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04899024

20200231

R01DA051848 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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239 participants in 2 patient groups

PARTI and CM (Contingency Management)

Experimental group

Description:

The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence

Treatment:

Behavioral: PARTI

Behavioral: Contingency Management for PrEP Adherence

Attention-Control and CM (Contingency Management)

Active Comparator group

Description:

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

Treatment:

Behavioral: Contingency Management for PrEP Adherence

Behavioral: Attention-Control