NCT02915367

Monitoring Pre-exposure Prophylaxis for Young Adult Women

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV/AIDS
• Adherence

Interventions

Type	Name	Description
BEHAVIORAL	SMS Reminders	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).

Timeline

• Start date: 2016-12-21
• Primary completion: 2020-03-20
• Completion: 2020-04-30
• First posted: 2016-09-27
• Last updated: 2023-05-31
• Results posted: 2022-04-08

Locations

2 sites across 1 country: Kenya