Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 348
- Locations
- 2
- Primary Endpoint
- Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 24 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
SMS Reminders
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
Intervention: SMS Reminders (Behavioral)
No Reminders
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
Outcomes
Primary Outcomes
Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
Time Frame: 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 Outcomes
- Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring(Month 1)
- USD Per Month(two years)
Investigators
Jessica Haberer, MD
Research Scientist
Massachusetts General Hospital