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

May 8, 2012
July 2, 2012
February 9, 2016
August 2011
February 2014   (Final data collection date for primary outcome measure)
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™).
Same as current
Complete list of historical versions of study NCT01632397 on Archive Site
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).
Same as current
Not Provided
Not Provided
Pre-exposure Prophylaxis Adherence Intervention for MSM
Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Medication Adherence
  • Behavioral: CBT-based counseling
    Cognitive Behavior Therapy for PrEP adherence
  • Behavioral: Health education and supportive counseling
    Time matched general supportive therapy of the type commonly available from community therapists.
  • Experimental: CBT-based counseling
    Cognitive behavioral based intervention to promote PrEP adherence.
    Intervention: Behavioral: CBT-based counseling
  • Active Comparator: Health education and supportive counseling
    Time matched supportive counseling
    Intervention: Behavioral: Health education and supportive counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1R34MH095584-01( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Kenneth H. Mayer, MD, Fenway Community Health
Fenway Community Health
Not Provided
Principal Investigator: Kenneth Mayer, MD Fenway Health
Fenway Community Health
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP