Pre-exposure Prophylaxis Adherence Intervention for MSM (PrEPare)
|ClinicalTrials.gov Identifier: NCT01632397|
Recruitment Status : Completed
First Posted : July 2, 2012
Last Update Posted : February 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence||Behavioral: CBT-based counseling Behavioral: Health education and supportive counseling||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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™).
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632397
|United States, Massachusetts|
|The Fenway Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Kenneth Mayer, MD||Fenway Health|