Pepped on Pre-exposure Prophylaxis (PrEP): Pilot-randomized Controlled Trial (RCT) to Assess the Feasibility/Acceptability of the Pepped-for-PrEP Package (Counseling and Problem-solving PrEP Adherence Intervention With Behavioral Activation (BA) Approach) Among Stimulant Abusing MSM.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PrEP Uptake
- Sponsor
- Brown University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- PrEP Uptake
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA) approach that aims to re-engage participants in safe but pleasurable activities in life and addresses stimulant-abuse as well as associated factors including depression, as barriers to optimal PrEP adherence.
Detailed Description
Enrolled participants will receive a referral to the Miriam Hospital for standard of care PrEP treatment. Once prescribed PrEP through the Miriam Hospital, the study participants will be randomly assigned to one of two treatment conditions. In the intervention condition, participants will receive a two-stepped intervention which could include up to 10 free BA and risk reduction (RR) counseling sessions. Participants assigned to the comparison condition will receive the standard of care for PrEP treatment at the Miriam Hospital, which includes information about PrEP and how to obtain it, assistance from medical staff in obtaining health insurance for study participants, and information regarding local community resources.
Investigators
Matthew Mimiaga
Professor, Departments of Behavioral & Social Health Sciences and Epidemiology, School of Public Health Professor, Department of Psychiatry & Human Behavior, Alpert Medical School Director, Center for Health Equity Research (CHER)
Brown University
Eligibility Criteria
Inclusion Criteria
- •Age: 18 years or older
- •Sex: assigned male sex at birth
- •Self-reports having sex with another man in the past month while using stimulants
- •Self-reports behavioral risk for HIV infection (consistent with the Center for Disease Control guidelines) for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the preceding six months)
- •Not currently prescribed PrEP at initial visit
- •Able to speak and understand English (for consenting and counseling)
- •Lives in New England
Exclusion Criteria
- •1.) Potential participants unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate.
Outcomes
Primary Outcomes
PrEP Uptake
Time Frame: Baseline Stage 2
\>80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline.
Improve rate of PrEP adherence
Time Frame: Baseline Stage 2 and four month assessment
Self report adherence to assess for change in adherence.
Secondary Outcomes
- Reduce Unsafe Sex(Baseline Stage 1,Baseline Stage 2 and four month assessment)
- Reduce Stimulant Use(Baseline Stage 1,Baseline Stage 2 and four month assessment)