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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Tailored Positive Affect Intervention
BehavioralThe 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
BehavioralIncentives 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
Trial 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.
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.
Condomless Anal Sex (CAS)
Changes in the number of CAS partners who are not taking PrEP or virally suppressed.
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.
Locations
Sponsors and contacts
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University of Florida
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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