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OpenTrials
Completed

NCT Number: NCT04205487

PrEP Readiness Interventions for Supporting Motivation

The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men (MSM) into the pre-exposure prophylaxis (PrEP) care continuum.

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Key information

Conditions

HIV Infections Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Pre-exposure Prophylaxis RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance Use Disorders Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami School of Medicine

Miami, Florida, 33136, United States

About this study

In Stage 1, participants will be randomized to receive either: 1) three months of CM; or 2) two sessions of MI. All participants will be assessed at three months post-randomization for non-response. In Stage 2, a second randomization where non-responders (i.e., those who have not filled a PrEP prescription) are assigned to: 1) Switch to sequentially receive the other intervention (i.e., CM+MI or MI+CM); or 2) Continue with assessments only (i.e., CM-Only or MI-Only). All participants will complete a final assessment at 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Sexually active cisgender sexual minority man
  • Reports using stimulants in the past three months
  • HIV-negative serostatus
  • Meets Centers for Disease Control and Prevention (CDC) criteria for PrEP eligibility

Exclusion criteria

  • Currently prescribed PrEP
  • Unable to provide informed consent
  • Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to participate

Treatment and study plan

Motivational Interviewing (MI)

Behavioral

Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.

Contingency management (CM)

Behavioral

CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.

Primary outcomes

  1. Proportion of Participants Filling a Prescription for PrEP

    Time frame: 6 Months

    The proportion of participants who provide evidence that they have filled a PrEP prescription

Secondary outcomes

  1. Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider

    Time frame: 6 Months

    The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP.

  2. Clinical Cut Points for Self-reported Methamphetamine Use Severity

    Time frame: 6 months

    Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores indexing the severity of methamphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).

  3. Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS)

    Time frame: 6 months

    Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS. The proportion of participants reporting any receptive CAS will be reported.

  4. Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS)

    Time frame: 6 months

    Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS. The proportion of participants reporting any insertive CAS will be reported.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • City University of New York
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

PrEP Readiness Interventions for Supporting Motivation in Stimulant-Using Sexual Minority Men

Acronym: PRISM

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 19, 2019
Registry last updated
Jun 29, 2025

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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