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

Adherence, Medication Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137342
• Other study ID #: 1610001629
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Medication
• PrEP Uptake
• Stimulant Abuse

Intervention

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.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Improve rate of PrEP adherence	Self report adherence to assess for change in adherence.	Baseline Stage 2 and four month assessment
Secondary	Reduce Unsafe Sex	Self report sexual history to assess for change in sexual risk.	Baseline Stage 1,Baseline Stage 2 and four month assessment
Secondary	Reduce Stimulant Use	Self report stimulant use to assess for change in drug use.	Baseline Stage 1,Baseline Stage 2 and four month assessment