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NCT Number: NCT07281378

Reducing Co-occurring Substance Use and HIV Risk Among Stimulant-using Men at High Risk for HIV in the United States of America.

This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP). The study is a pilot randomized controlled trial to evaluate the adaptation, feasibility, acceptability, and preliminary efficacy of a behavioral intervention.

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Key information

Conditions

Drug Use Disorders Chemically-Induced Disorders HIV Risk Behavior Mental Disorders PrEP Adherence PrEP Uptake Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • be 18 years of age or older;
  • be sexually active cisgender men at high risk for HIV (foreign and US-born, residing in the US)-reporting any condomless anal sex (CAS) in the past three months with a man;
  • report use of stimulant (i.e., methamphetamine, powder cocaine, or crack-cocaine) at least one day in the past three or six month;
  • have HIV-negative serostatus;
  • be bilingual (Spanish and English), or Spanish or English monolingual;
  • meet CDC criteria for PrEP eligibility.

Exclusion criteria

  • display diminished capacity to consent (e.g., cognitive impairment); or
  • severe psychiatric symptoms (e.g., psychosis) that require more intensive treatment;
  • if they are HIV positive or living with HIV;
  • if they are already taking PrEP; and
  • if the participant can't consent to participate in English or Spanish.

Treatment and study plan

Tailored Positive Affect Intervention

Behavioral

The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. T

The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks;(3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory.

Contingency Management

Behavioral

Incentives will be provided as positive reinforcement of two key behaviors that are crucial to increase PrEP uptake. First, participants will receive incentives for documented evidence that they have completed a medical visit for PrEP clinical evaluation (including HIV testing). Second, participants completing PrEP clinical evaluation will receive incentives when they document evidence of an active prescription of PrEP.

Primary outcomes

  1. Rate of PrEP uptake

    Time frame: From enrollment to 6 months

    Changes in number of participants obtaining prescription to begin PrEP. Measured through documented evidence of an active prescription for PrEP.

Secondary outcomes

  1. Stimulant use (self-report)

    Time frame: Enrollment to 6 months

    Changes in the severity of participant stimulant use as measured by the Alcohol, Smoking, and Substance Involvement Screen Test (ASSIST) composite scores for cocaine and amphetamine-type stimulants.

  2. Condomless Anal Sex (CAS)

    Time frame: From enrollment to 6 months

    Changes in the number of CAS partners who are not taking PrEP or virally suppressed.

  3. Social Network Composition

    Time frame: From enrollment to 6 months

    Changes in the number of social network alters who use stimulants and increases in the number of social network alters who are taking PrEP.

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Colon-Burgos, DrPH

CONTACT

[email protected]

(352) 273-9188

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Jun 30, 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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