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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).

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Key information

Conditions

HIV Methamphetamine Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida International University

Miami, Florida, 33199, United States

Location status: Recruiting

Location contact

Adam Carrico Professor, PhD

CONTACT

[email protected]

786-725-2034

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)

Behavioral

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.

Contingency management (CM)

Behavioral

Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.

Primary outcomes

  1. 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

  1. 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).

  2. 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+).

  3. 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.

  4. 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.

  5. 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.

Adam Carrico Professor, PhD

CONTACT

[email protected]

305-348-7887

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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