HIV Prevention, Medication Adherence, Stimulant Use
Conditions
Keywords
Sexual Minority Men, HIV, PrEP Adherence, Contingency Management
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.
Interventions
BEHAVIORALPARTI
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.
BEHAVIORALAttention-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.
BEHAVIORALContingency 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.
Sponsors
Florida International University
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Engaging HIV Acquisition Risk | Up to 12 months | Percentage of participants engaging in HIV acquisition risk (i.e., defined as tenofovir - diphosphate levels from dried blood spots that are indicative of less than four oral PrEP doses per week AND any self-reported recent condomless anal sex) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Persistence | Up to 12 months | Percentage of participants who continue taking PrEP medication |
| Retention in PrEP Care | Up to 12 months | Percentage of participants who report attending a medical visit with the PrEP provider in the past three months |
| Self-Reported Stimulant Use Severity | 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). |
| Positive Affect | 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. |
| PrEP Self-Efficacy | Up to 12 months | A 10-item self-reported measure where higher scores (Range = 9-90) reflect greater perceived self-efficacy for managing PrEP. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdam W Carrico, PhD
Florida International University
Outcome results
None listed