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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Attention-Control conditionOther 1 intervention
Group B: Experimental conditionExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
From enrollment to 6 months

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: