Medication Adherence
Conditions
Keywords
PrEP, HIV, Adherence, MSM, Men having sex with men
Brief summary
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.
Interventions
BEHAVIORALCBT-based counseling
Cognitive Behavior Therapy for PrEP adherence
BEHAVIORALHealth education and supportive counseling
Time matched general supportive therapy of the type commonly available from community therapists.
Sponsors
Fenway Community Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* male sex at birth * being 18 years old or older * testing HIV-negative at screening * evidence of high risk for HIV acquisition defined by having unprotected anal sex (insertive or receptive) with an HIV-positive male partner OR at least a total of three episodes of unprotected anal sex with at least two partners in the last three months * medically cleared to take the study drug (ambulatory performance \>=60 on Karnofsky scale, adequate renal function, negative glucose and protein in urine, adequate hepatic function, adequate hematologic function) * able to understand and speak English (for consenting and counseling).
Exclusion criteria
* participants who are not able to consent due to psychiatric or cognitive concerns * those who have already been prescribed PrEP * having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis B, history of pathological bone fractures not related to trauma) * receiving ongoing therapy with ART, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents * receiving or possibly receiving antiretroviral drugs for an anti-HIV vaccine in a clinical trial * active alcohol or drug use that would interfere with study participation * having other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to PrEP over time | 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™). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Risk Compensation | 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). |
Countries
United States
Outcome results
None listed