Monitoring Pre-exposure Prophylaxis for Young Adult Women

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

Detailed Description
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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.

Official Title
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Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women

Conditions
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HIV/AIDS, Adherence

Intervention / Treatment
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* Behavioral: SMS Reminders


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS Reminders<br>Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device. | Behavioral: SMS Reminders<br>* Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).<br>|
| No Intervention: No Reminders<br>Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring | 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) | Month 1 | 
| USD Per Month | Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMS, HIV/AIDS, adherence, women, real time monitoring, risk, mHealth