Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men
Overview
- Phase
- Not Applicable
- Intervention
- Contingency Management (CM)
- Conditions
- HIV
- Sponsor
- Florida International University
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Proportion of Participants with Verified PrEP or ART Use
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This is a hybrid type I, factorial randomized controlled trial to test the comparative and combined effectiveness of contingency management (CM) alone or CM with motivational interviewing (MI) for optimizing entry or re-entry into the PrEP care continuum. A total of 400 participants will be randomized to CM (n = 200) or MI+CM (n = 200), all delivered via Telehealth. Monthly follow-up assessments will be completed over 12 months to examine differential effectiveness for the primary outcome - filling a PrEP prescription (verified using a digital photo or detectable tenofovir diphosphate). Secondary outcomes will include: self-reported PrEP clinical evaluation by a PrEP provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).
Investigators
Adam Carrico, PhD
Professor
Florida International University
Eligibility Criteria
Inclusion Criteria
- •18 years or older
- •Assigned male a birth
- •Self-reported methamphetamine use in the past 3 months
- •Has not filled a PrEP prescription in the past 6 months
Exclusion Criteria
- •Unwilling or unable to provide informed consent
Arms & Interventions
Contingency Management
Provides incentives for initiating PrEP care ($50) and filling a PrEP prescription ($50) in the three months following randomization.
Intervention: Contingency Management (CM)
MI+CM
Both the CM and MI interventions described above.
Intervention: Motivational Interviewing (MI)
MI+CM
Both the CM and MI interventions described above.
Intervention: Contingency Management (CM)
Outcomes
Primary Outcomes
Proportion of Participants with Verified PrEP or ART Use
Time Frame: 12 Months
The proportion of participants providing evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of injectable medication from a medical record OR a dried blood spot with detectable tenofovir diphosphate for those taking daily oral PrEP OR a viral load \< 300 copies/mL for those taking ART)
Secondary Outcomes
- Clinical Cut Points for Self-Reported Methamphetamine Use Severity(12 Months)
- Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)(12 Months)
- Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)(12 Months)
- Proportion of Participants with Prevention Effective PrEP Use(12 Months)
- Median Time to Verified PrEP or ART Use(12 Months)