Pepped on Pre-exposure Prophylaxis (PrEP): A Counseling and Problem-Solving PrEP Adherence Intervention for Stimulant Using Men Who Have Sex With Men (MSM).

Brown University15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

PrEP Uptake Stimulant Abuse

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 18 years or older 2. Sex: assigned male sex at birth 3. Self-reports having sex with another man in the past month while using stimulants 4. 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) 5. Not currently prescribed PrEP at initial visit 6. Able to speak and understand English (for consenting and counseling) 7. 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

\>80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline.

Time frame: Baseline Stage 2

Improve rate of PrEP adherence

Wisepill electronic pill dispenser will monitor when the pill dispenser is opened to measure medication adherence .

Time frame: Daily beginning at Stage 2 Baseline up to the four month assessment visit

Improve rate of PrEP adherence

Self report adherence to assess for change in adherence.

Time frame: Baseline Stage 2 and four month assessment

Secondary Outcomes

Reduce Unsafe Sex

Self report sexual history to assess for change in sexual risk.

Time frame: Baseline Stage 1,Baseline Stage 2 and four month assessment

Reduce Stimulant Use

Self report stimulant use to assess for change in drug use.