Drug Use Disorders, HIV Risk Behavior, PrEP Adherence, PrEP Uptake
Conditions
Keywords
PrEP, PrEP uptake, HIV, substance use, stimulant use, men at high risk for HIV
Brief summary
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.
Interventions
BEHAVIORALTailored Positive Affect Intervention
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.
BEHAVIORALContingency Management
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.
Sponsors
University of Florida
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of PrEP uptake | From enrollment to 6 months | Changes in number of participants obtaining prescription to begin PrEP. Measured through documented evidence of an active prescription for PrEP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stimulant use (self-report) | Enrollment to 6 months | 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) | From enrollment to 6 months | Changes in the number of CAS partners who are not taking PrEP or virally suppressed. |
| Social Network Composition | From enrollment to 6 months | Changes in the number of social network alters who use stimulants and increases in the number of social network alters who are taking PrEP. |
Contacts
CONTACTJose Colon-Burgos, DrPH
PRINCIPAL_INVESTIGATORJose Colon-Burgos, DrPH
University of Florida
Outcome results
None listed