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

University of Florida

Status: Not yet enrolling

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

Treatments: Behavioral: Tailored Positive Affect Intervention; Behavioral: Contingency Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07281378

5R00DA053158-05 (U.S. NIH Grant/Contract)

IRB202501242

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. be 18 years of age or older;
2. 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;
3. report use of stimulant (i.e., methamphetamine, powder cocaine, or crack-cocaine) at least one day in the past three or six month;
4. have HIV-negative serostatus;
5. be bilingual (Spanish and English), or Spanish or English monolingual;
6. meet CDC criteria for PrEP eligibility.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Attention-Control condition

Other group

Description:

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.

Treatment:

Behavioral: Contingency Management

Experimental condition

Experimental group

Description:

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.

Treatment:

Behavioral: Contingency Management

Behavioral: Tailored Positive Affect Intervention