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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
103
Cognitive Behavior Therapy for PrEP adherence
Time matched general supportive therapy of the type commonly available from community therapists.
The Fenway Institute
Boston, Massachusetts, United States
Adherence to PrEP over time
This is primarily a feasiblity pilot RCT. However, the primary eventual endpoint is PrEP adherence measured daily via electronic medication adherence monitoring (Wisepill™).
Time frame: At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)
Sexual Risk Compensation
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).
Time frame: At each of the 9 study visits spread over up to six months.
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