Pre-exposure Prophylaxis Adherence Intervention for MSM (PrEPare)

This study is currently recruiting participants.
Verified February 2013 by Fenway Community Health
Sponsor:
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health
ClinicalTrials.gov Identifier:
NCT01632397
First received: May 8, 2012
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Medication Adherence
Behavioral: CBT-based counseling
Behavioral: Health education and supportive counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM

Resource links provided by NLM:


Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • Adherence to PrEP over time [ Time Frame: At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months) ] [ Designated as safety issue: No ]
    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:
  • Sexual Risk Compensation [ Time Frame: At each of the 9 study visits spread over up to six months. ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 55
Study Start Date: August 2011
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT-based counseling
Cognitive behavioral based intervention to promote PrEP adherence.
Behavioral: CBT-based counseling
Cognitive Behavior Therapy for PrEP adherence
Active Comparator: Health education and supportive counseling
Time matched supportive counseling
Behavioral: Health education and supportive counseling
Time matched general supportive therapy of the type commonly available from community therapists.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632397

Contacts
Contact: Steven A Elsesser, BA 6179276462 selsesser@fenwayhealth.org

Locations
United States, Massachusetts
The Fenway Institute Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Fenway Community Health
Investigators
Principal Investigator: Kenneth Mayer, MD Fenway Health
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth H. Mayer, MD, Medical Research Director, Co-Chair of The Fenway Institute, Fenway Community Health
ClinicalTrials.gov Identifier: NCT01632397     History of Changes
Other Study ID Numbers: 1R34MH095584-01
Study First Received: May 8, 2012
Last Updated: February 21, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Fenway Community Health:
PrEP
HIV
Adherence
MSM
Men having sex with men

ClinicalTrials.gov processed this record on April 16, 2014