Florida International University
Miami, Florida, 33199, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06637436
PrEP Readiness Interventions for Sustained Motivation (PRISM)
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Motivational Interviewing (MI)
BehavioralThis 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.
Contingency management (CM)
BehavioralProvides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.
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 medication from a medical record)
Secondary outcomes
-
Median Time to Verified PrEP or ART Use
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Florida International University
Other
Registry information
Official study title
Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men
Acronym: PRISM
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Oct 15, 2024
- Registry last updated
- May 7, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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