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

NCT07281378 | Not Yet Recruiting DMC

• 2 other identifiers: IRB2025012425R00DA053158-05
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Drug Use Disorders; PrEP Uptake; PrEP Adherence; HIV Risk Behavior

Keywords

PrEP; PrEP uptake; HIV; substance use; stimulant use; men at high risk for HIV

Outcome Measures

Primary Outcomes (1)

• Rate of PrEP uptake

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

  From enrollment to 6 months

Secondary Outcomes (3)

• Stimulant use (self-report)

  Enrollment to 6 months

• Condomless Anal Sex (CAS)

  From enrollment to 6 months

• Social Network Composition

  From enrollment to 6 months

Study Arms (2)

Attention-Control condition

OTHER

Participants randomized to the control condition will have six 1-on-1 sessions with a facilitator engaging in writing exercises. The sessions will be comparable in length to the intervention sessions but will not include any skills practice. Each session will include a neutral writing exercises.

Behavioral: Contingency Management

Experimental condition

EXPERIMENTAL

Participants randomized to the experimental condition (tailored behavioral intervention) will have a 1-on-1 session with a facilitator. 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. The intervention will be led by a CITI certified facilitator, who is also a member of the study team. 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.

Behavioral: Tailored Positive Affect Intervention; Behavioral: Contingency Management

Interventions

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.

Experimental condition

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.

Attention-Control condition; Experimental condition

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Drug Abuse (NIDA): collaborator

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MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jose Colon-Burgos, DrPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Colon-Burgos, DrPH

CONTACT

(352) 273-9188; jcolonburgos@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 15, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 12 months after completion of the study
• Access Criteria: Data will be accessible via UF data repository