HIV, Methamphetamine Disorders
Conditions
Keywords
HIV prevention, Methamphetamine, Motivational Interviewing, Contingency Management
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).
Interventions
BEHAVIORALMotivational Interviewing (MI)
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.
BEHAVIORALContingency Management (CM)
Provides incentives for initiating PrEP care ($50) and filling a PrEP prescription ($50) in the three months following randomization.
Sponsors
Florida International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with Verified PrEP or ART Use | 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
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Verified PrEP or ART Use | 12 Months | 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). |
| Clinical Cut Points for Self-Reported Methamphetamine Use Severity | 12 Months | 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+). |
| Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS) | 12 Months | 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. |
| Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS) | 12 Months | 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. |
| Proportion of Participants with Prevention Effective PrEP Use | 12 Months | Proportion of participants taking daily oral PrEP with tenofovir-diphosphate levels of 700 mol/punch or greater |
Countries
United States
Contacts
CONTACTAdam Carrico Professor, PhD
Outcome results
None listed