Clinical trial NCT03137342: Pepped on Pre-exposure Prophylaxis (PrEP): A Counseling and Problem-Solving PrEP Adherence Intervention for Stimulant Using Men Who Have Sex With Men (MSM).
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PrEP Uptake
Stimulant Abuse
Adherence, Medication
Keywords: PrEP
Adherence
Risk Reduction
Stimulant Use
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Intervention Condition: Pepped-for-PrEP intervention counseling plus standard of care adherence counseling as part of their PrEP related care via The Miriam Hospital Control Condition: only the standard of care adherence counseling as part of their PrEP related care via The Miriam Hospital.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PrEP Uptake
timeFrame: Baseline Stage 2
measure: Improve rate of PrEP adherence
timeFrame: Daily beginning at Stage 2 Baseline up to the four month assessment visit
measure: Improve rate of PrEP adherence
timeFrame: Baseline Stage 2 and four month assessment
Secondary outcomes:
measure: Reduce Unsafe Sex
timeFrame: Baseline Stage 1,Baseline Stage 2 and four month assessment
measure: Reduce Stimulant Use
timeFrame: Baseline Stage 1,Baseline Stage 2 and four month assessment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University, School of Public Health, Center for Health Equity Research
name: Matthew J Mimiaga, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: