Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-20 @ 3:39 PM
Study NCT ID:
NCT02915367
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2016-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Monitoring Pre-exposure Prophylaxis for Young Adult Women
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MPYA
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: