Next Generation Real-time Monitoring for Pre-exposure Prophylaxis (PrEP) Adherence in Young Kenyan Women

Adherence is key to the effectiveness of oral tenofovir-based pre-exposure prophylaxis (PrEP) for HIV prevention. Strategies to monitor adherence and react to adherence challenges are needed, particularly strategies that are ready for use now as PrEP is being rolled out. Strategies are needed that are implementable for different cultural and economic settings. One of the first devices to enable real-time adherence monitoring is an electronic pill bottle called Wisepill, which records and wirelessly transmits a time-and-date stamp with each opening. This device detects of non-adherence as it occurs and allows for immediate adherence intervention, exactly when needed. Importantly, no steps beyond opening the device are necessary to trigger adherence measurement, such as biologic sampling or pill modifications. These qualities are attractive for developing a workable monitoring approach for diverse settings. The research team has shown Wisepill to be feasible, acceptable, and valid for monitoring antiretroviral therapy (ART) adherence in rural Uganda. Recent advances in battery life, connectivity, user interface, and manufacturing have made a next-generation Wisepill device that overcomes challenges seen in other settings with significantly lower costs, transforming it into a “plug and play” technology that is ready for implementing in resource-limited settings, for both research and clinical use. The potential for real-time PrEP monitoring with Wisepill has been underexplored, with work largely limited to observational studies (i.e., measuring adherence only) or combined with simple dosing reminders (e.g., a single SMS) that are unlinked to Wisepill data. No studies have assessed Wisepill for real-time adherence feedback, an intervention that has great promise for increasing adherence to PrEP, particularly for settings where cell phones are common and mobile technology for health is rapidly developing. Real-time monitoring and phone-based feedback may be particularly important for young African women receiving PrEP, because this population (1) is at high risk for HIV, (2) has great need for effective prevention interventions under their control, and (3) had important adherence challenges in clinical trials of PrEP. Real-time adherence monitoring coupled with a feedback intervention may also have a maximum impact when paired with real-time assessment of a person’s behavioral risk, which is likely to be dynamic. PrEP is not forever, and PrEP adherence matched to risk exposure is critical for effective HIV prevention. This study uses the next-generation Wisepill to explore the combination of real-time adherence monitoring with real-time adherence feedback, triangulated with real-time assessment of sexual risk behavior. Young HIV-uninfected Kenyan women initiating PrEP will be studied. New Kenyan HIV prevention policies prioritize young women at risk for PrEP delivery and thus ready-to-go monitoring and feedback tools that are feasible and acceptable to this population are needed now.

Principal Investigator: Harsha Thirumurthy

Funding Source: NIH Massachusetts General Hospital

Grant Number: R01MH109309

Funding Period: 6/22/2016 - 4/30/2017

Primary Research Area: Population Health

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