An interventional study of Tailored Positive Affect Intervention and Contingency Management in Drug Use Disorders, PrEP Uptake and PrEP Adherence, sponsored by University of Florida. Not yet recruiting. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of Florida · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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
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
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.
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.
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
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
No study locations are listed for this record.
Plan to share: Yes — De-identified datasets from the study will be shared.
Supporting information: Study protocol, Icf
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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University of Florida