An interventional study of Motivational Interviewing (MI) and Contingency Management (CM) in HIV and Methamphetamine Disorders, sponsored by Florida International University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Florida International University · Not applicable, Interventional, and Prevention
This is a hybrid type I randomized controlled trial to test the effectiveness of contingency management (CM) alone versus CM with motivational interviewing (MI) for optimizing entry or re-entry into the HIV prevention or care continua. 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 effectiveness MI+CM for the primary outcome - filling a pre-exposure prophylaxis (PrEP) or anti-retroviral therapy (ART) prescription (verified using a digital photo). Secondary outcomes will include: self-reported PrEP or ART clinical evaluation by a provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).
Florida International University is the lead sponsor of 102 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.
Behavioral: Contingency Management (CM)
Two session MI counseling intervention delivered in the three months after randomization with CM.
Behavioral: Motivational Interviewing (MI) · Behavioral: Contingency Management (CM)
This telehealth MI intervention seeks to increase intrinsic motivation and self-efficacy for starting or restarting PrEP in session one. Session two focuses on concomitant risk behaviors such as substance use and CAS.
Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.
Proportion 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 medication from a medical record)
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 medication from a medical record).
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 or ART Use
Proportion of participants taking daily oral PrEP with tenofovir-diphosphate levels commensurate with at least four doses per week OR HIV viral load \< 300 copies/mL from dried blood spot samples
Time frame: 12 Months
Plan to share: Yes — De-identified data will be uploaded to a secure database after the team completes intent-to-treat analyses of the primary and secondary outcomes.
Supporting information: Study protocol, Icf, Analytic code
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Florida International University