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Pre-exposure Prophylaxis Adherence Intervention for MSM (PrEPare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632397
Recruitment Status : Completed
First Posted : July 2, 2012
Last Update Posted : February 9, 2016
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM
Study Start Date : August 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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) ]
    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 :
  1. Sexual Risk Compensation [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01632397

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United States, Massachusetts
The Fenway Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Fenway Community Health
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Principal Investigator: Kenneth Mayer, MD Fenway Health
Additional Information:
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Responsible Party: Kenneth H. Mayer, MD, Medical Research Director, Co-Chair of The Fenway Institute, Fenway Community Health Identifier: NCT01632397    
Other Study ID Numbers: 1R34MH095584-01 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2012    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Keywords provided by Kenneth H. Mayer, MD, Fenway Community Health:
Men having sex with men