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

Study Overview
=================
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.

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.

Conditions
-----------------
PrEP Uptake, Stimulant Abuse, Adherence, Medication

Intervention / Treatment
-----------------
* Behavioral: Pepped on PrEP Package


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pepped on PrEP<br>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<br>* 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.<br>|
| No Intervention: Standard of Care<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PrEP, Adherence, Risk Reduction, Stimulant Use