Pre-exposure Prophylaxis Adherence Intervention for MSM

Phase 4

Completed

• Conditions: Medication Adherence
• Interventions: Behavioral: CBT-based counseling; Behavioral: Health education and supportive counseling

• Registration Number: NCT01632397
• Lead Sponsor: Fenway Community Health

Brief Summary

Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 103

Inclusion Criteria

• male sex at birth
• being 18 years old or older
• testing HIV-negative at screening
• evidence of high risk for HIV acquisition defined by having unprotected anal sex (insertive or receptive) with an HIV-positive male partner OR at least a total of three episodes of unprotected anal sex with at least two partners in the last three months
• medically cleared to take the study drug (ambulatory performance >=60 on Karnofsky scale, adequate renal function, negative glucose and protein in urine, adequate hepatic function, adequate hematologic function)
• able to understand and speak English (for consenting and counseling).

Exclusion Criteria

• participants who are not able to consent due to psychiatric or cognitive concerns
• those who have already been prescribed PrEP
• having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis B, history of pathological bone fractures not related to trauma)
• receiving ongoing therapy with ART, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents
• receiving or possibly receiving antiretroviral drugs for an anti-HIV vaccine in a clinical trial
• active alcohol or drug use that would interfere with study participation
• having other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-based counseling	CBT-based counseling	Cognitive behavioral based intervention to promote PrEP adherence.
Health education and supportive counseling	Health education and supportive counseling	Time matched supportive counseling

Primary Outcome Measures

Name	Time	Method
Adherence to PrEP over time	At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)	This is primarily a feasiblity pilot RCT. However, the primary eventual endpoint is PrEP adherence measured daily via electronic medication adherence monitoring (Wisepill™).

Secondary Outcome Measures

Name	Time	Method
Sexual Risk Compensation	At each of the 9 study visits spread over up to six months.	This is primarily a feasiblity RCT. Sexual risk compensation is defined as a potential change in sexual risk taking behaviors (unprotected anal sex). This is measured daily with text message assessments for sexual risk as well as at each study visit with self-report measure(s).

Trial Locations

Locations (1)

The Fenway Institute; 🇺🇸 Boston, Massachusetts, United States