Monitoring Pre-exposure Prophylaxis for Young Adult women (MPYA)
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202003804048902
- Lead Sponsor
- niversity of Washington
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Female
- Target Recruitment
- 175
Female
· HIV-uninfected (as determined by Kenya national testing algorithms)
· Age 18-24 years
· Wanting to start PrEP with an initial recommendation of 6 months of use
· Clinically safe to receive PrEP, in accordance with CDC guidelines:
Creatinine clearance >60 mL/min
Not infected with hepatitis B
No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study
· Sexually active (defined as vaginal or anal sex) within the last 3 months
· At high risk for HIV infection based on a score of >5 or being in an HIV serodiscordant relationship
· Not pregnant
· Owns a personal cell phone (not shared) compatible with the technology used in the study and the ability to charge it
· Intending to stay in the area for at least the next year
Unable to provide consent
Breast-feeding (Truvada is not currently approved for use during breast-feeding)
Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Wisepill adherence (enacted adherence and persistence)<br>?Tenofovir concentration as a marker of adherence <br>?Feasibility of Wisepill monitoring and SMS reminders<br>?Acceptability of Wisepill monitoring and SMS reminders<br>?Ease of use, health care associated costs, and cost-effectiveness of Wisepill monitoring and SMS reminders<br>?Validity of Wisepill monitoring compared to tenofovir concentration in DBS<br>
- Secondary Outcome Measures
Name Time Method Completion of PrEP refills