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

Sponsor

Brown University (Other)

Overall Status

Completed

CT.gov ID

NCT03137342

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PrEP Uptake Stimulant Abuse Adherence, Medication	Behavioral: Pepped on PrEP Package	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcome assessor will be blind to the participant's assigned intervention.

Primary Purpose:

Prevention

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.

Actual Study Start Date :

May 1, 2017

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

PrEP Uptake [Baseline Stage 2]
>80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline.
Improve rate of PrEP adherence [Daily beginning at Stage 2 Baseline up to the four month assessment visit]
Wisepill electronic pill dispenser will monitor when the pill dispenser is opened to measure medication adherence .
Improve rate of PrEP adherence [Baseline Stage 2 and four month assessment]
Self report adherence to assess for change in adherence.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brown University School of Public Health	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

Brown University

Investigators

Principal Investigator: Matthew J Mimiaga, ScD, MPH, Brown University, School of Public Health, Center for Health Equity Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matthew Mimiaga, 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), Brown University

ClinicalTrials.gov Identifier:

NCT03137342

Other Study ID Numbers:

1610001629

First Posted:

May 2, 2017

Last Update Posted:

Jul 11, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Matthew Mimiaga, 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), Brown University

Study Results

No Results Posted as of Jul 11, 2018