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

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.

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.

Study Overview

• Status: Completed
• Conditions: Adherence, Medication; Stimulant Abuse; PrEP Uptake
• Intervention / Treatment: Behavioral: Pepped on PrEP Package

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown University School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pepped on PrEP; 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; 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.
No Intervention: Standard of Care; PrEP adherence counseling from the Miriam Hospital PrEP Clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce Unsafe Sex	Self report sexual history to assess for change in sexual risk.	Baseline Stage 1,Baseline Stage 2 and four month assessment
Reduce Stimulant Use	Self report stimulant use to assess for change in drug use.	Baseline Stage 1,Baseline Stage 2 and four month assessment

Collaborators and Investigators

• Sponsor: Brown University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Adherence; PrEP; Risk Reduction; Stimulant Use
• Other Study ID Numbers: 1610001629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No