The Fenway Institute
Boston, Massachusetts, 02215, United States
NCT Number: NCT01632397
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.
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Notify Me18 year and older
Male
Interventional
Phase 4
Boston, Massachusetts, 02215, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive Behavior Therapy for PrEP adherence
Time matched general supportive therapy of the type commonly available from community therapists.
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™).
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).
Fenway Community Health
Other
Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM
Acronym: PrEPare
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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