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

NCT03137342 | Completed DMC

• 1 other identifier: 1610001629
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP Uptake; Stimulant Abuse; Adherence, Medication

Keywords

PrEP; Adherence; Risk Reduction; Stimulant Use

Outcome Measures

Primary Outcomes (3)

• PrEP Uptake

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

  Baseline Stage 2

• Improve rate of PrEP adherence

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

  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.

  Baseline Stage 2 and four month assessment

Secondary Outcomes (2)

• 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

Study Arms (2)

Pepped on PrEP

EXPERIMENTAL

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.

Behavioral: Pepped on PrEP Package

Standard of Care

NO INTERVENTION

PrEP adherence counseling from the Miriam Hospital PrEP Clinic.

Interventions

Pepped on PrEP Package BEHAVIORAL

A counseling and problem-solving adherence intervention with a Behavioral Activation approach 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.

Pepped on PrEP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men who have sex with men and report stimulant use at screening
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ) 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.

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Medication Adherence; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Matthew J Mimiaga, ScD, MPH

  Brown University, School of Public Health, Center for Health Equity Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blind to the participant's assigned intervention.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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)

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: May 2, 2017
• Study Start: May 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)