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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
400
This telehealth MI intervention seeks to increase intrinsic motivation and self-efficacy for starting or restarting pre-exposure prophylaxis (PrEP) in session one. Session two focuses on concomitant risk behaviors such as substance use and CAS.
Provides incentives for initiating PrEP care ($50) and filling a PrEP prescription ($50) in the three months following randomization.
Florida International University Stempel College of Public Health and Social Work
Miami, Florida, United States
NOT_YET_RECRUITINGFlorida International University
Miami, Florida, United States
RECRUITINGProportion of Participants with Verified PrEP or ART Use
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)
Time frame: 12 Months
Median Time to Verified PrEP or ART Use
The number of days after randomization until 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 tenofvir diphosphate for those taking daily oral PrEP OR a viral load \< 300 copies/mL for those taking ART).
Time frame: 12 Months
Clinical Cut Points for Self-Reported Methamphetamine Use Severity
Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores for the severity of amphetamine and other substance use (Mild = 0-3; Moderate = 4-26; Severe = 27+).
Time frame: 12 Months
Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)
Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS in the past 3 months. Changes in the mean number of insertive CAS partners will be examined.
Time frame: 12 Months
Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)
Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS in the past 3 months. Changes in the mean number of receptive CAS partners will be examined.
Time frame: 12 Months
Proportion of Participants with Prevention Effective PrEP Use
Proportion of participants taking daily oral PrEP with tenofovir-diphosphate levels of 700 mol/punch or greater
Time frame: 12 Months
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