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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-based counseling | Experimental | Cognitive behavioral based intervention to promote PrEP adherence. |
|
| Health education and supportive counseling | Active Comparator | Time matched supportive counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-based counseling | Behavioral | Cognitive Behavior Therapy for PrEP adherence |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (Wisepillâ„¢). | At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At each of the 9 study visits spread over up to six months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Mayer, MD | Fenway Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fenway Institute | Boston | Massachusetts | 02215 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Health education and supportive counseling |
| Behavioral |
Time matched general supportive therapy of the type commonly available from community therapists. |
|
| D001519 | Behavior |