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.|
|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).
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 ClinicalTrials.gov identifier (NCT number): NCT01632397
|United States, Massachusetts|
|The Fenway Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Kenneth Mayer, MD||Fenway Health|