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 University

Status: Completed

Conditions: Stimulant Abuse; PrEP Uptake; Adherence, Medication

Treatments: Behavioral: Pepped on PrEP Package

Study type: Interventional

Funder types: Other

Identifiers

NCT03137342

1610001629

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Pepped on PrEP

Experimental group

Description:

Using an efficient stepped care ("adaptive") model, all participants will receive three sessions of PrEP-STEPS counseling for PrEP adherence delivered by a Masters-level or above therapist. Some individuals may require a more intensive approach. These participants will receive an additional seven counseling sessions of behavioral activation with integrated cognitive behavioral therapy (CBT) designed to reduce stimulant use and promote positive behaviors.

Treatment:

Behavioral: Pepped on PrEP Package

Standard of Care

No Intervention group

Description:

PrEP adherence counseling from the Miriam Hospital PrEP Clinic.