Monitoring Pre-exposure Prophylaxis for Young Adult Women

Not Applicable

Completed

Brief Summary: Next generation real-time monitoring for PrEP adherence in young Kenyan women

Detailed Description: This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered HIV pre-exposure prophylaxis (PrEP) for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive short message service (SMS) reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence.

Recruitment & Eligibility

Inclusion Criteria

HIV-uninfected (as determined by Kenya national testing algorithms)
Wanting to start PrEP with an initial recommendation of 6 months of use
Clinically safe to receive PrEP, in accordance with Centers for Disease Control and Prevention (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 validated risk score of >5 or being in an HIV serodiscordant relationship
Not pregnant
Owns a personal cell phone (not shared) compatible with study protocols and the ability to charge it
Ability to send a text message
Intending to stay in the area for at least the next year
Willing to use study criteria

Exclusion Criteria

Unable to provide consent
Breast-feeding (PrEPis 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.

Primary Outcome Measures

Name	Time	Method
Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months	up to 2 years follow-up	Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring	Month 1	Questionnaire indicating "very interested" in using the Wisepill monitor (a pill box that records the date and time of each opening as a proxy for pill ingestion)
USD Per Month	two years	Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted