Monitoring Pre-exposure Prophylaxis for Young Adult Women

HIV/AIDS Clinical Trial

— MPYA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915367
• Other study ID #: R01MH109309
• Status: Completed
• Phase: N/A
• Start date: December 21, 2016
• Est. completion date: April 30, 2020

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Next generation real-time monitoring for PrEP adherence in young Kenyan women

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: April 30, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Adherence
• HIV Infections
• HIV/AIDS

Intervention

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).

Locations

Country	Name	City	State
Kenya	KEMRI	Kisumu
Kenya	KEMRI	Thika

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Kenya Medical Research Institute, University of Washington

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Risk Perception	Assess self-reported weekly HIV risk perception through an automated SMS survey	up to 2 years follow-up
Other	Adherence Measure Performance	Tenofovir concentration in DBS compared to electronic adherence data from the prior 30 days for each participant.	up to 2 years follow-up
Other	Pregnancy Outcomes	Descriptive measures of infants exposed to PrEP during gestation	6 months post-partum or end of the study
Primary	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	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
Secondary	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