HIV, Methamphetamine Disorders
Conditions
Keywords
HIV prevention, Methamphetamine, Motivational Interviewing, Contingency Management
Brief summary
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).
Interventions
BEHAVIORALMotivational Interviewing (MI)
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.
BEHAVIORALContingency Management (CM)
Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART 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 * HIV-negative or unknown serostatus at baseline * 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 medication from a medical record) |
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 medication from a medical record). |
| 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 or ART Use | 12 Months | 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 |
Countries
United States
Contacts
CONTACTAdam Carrico Professor, PhD
Outcome results
None listed