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

N/ANot Yet RecruitingNCT07281378

University of Florida84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Drug Use Disorders PrEP Uptake PrEP Adherence HIV Risk Behavior

Interventions

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 ManagementBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Rate of PrEP uptake

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

Time frame: From enrollment to 6 months

Secondary Outcomes

Stimulant use (self-report)

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.

Time frame: Enrollment to 6 months

Condomless Anal Sex (CAS)

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

Time frame: From enrollment to 6 months

Social Network Composition

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

Time frame: From enrollment to 6 months

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts