Monitoring Pre-exposure Prophylaxis for Young Adult Women (MPYA)

May 29, 2023 updated by: Jessica Haberer, MD, Massachusetts General Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

348

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • KEMRI
      • Thika, Kenya
        • KEMRI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMS Reminders
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
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).
No Intervention: No Reminders
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
Time Frame: up to 2 years follow-up
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
Time Frame: Month 1
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
Time Frame: two years
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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

University of Washington
Kenya Medical Research Institute

Investigators

  • Principal Investigator: Jessica Haberer, MD, MS, Massachussetts General Hospital
  • Study Director: Nelly Mugo, Kenya Medical Research Institute
  • Study Director: Elizabeth Bukusi, Kenya Medical Research Institute
  • Principal Investigator: Jared Baeten, MD, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2016

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimated)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH109309 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available at the end of the study upon request.

IPD Sharing Time Frame

Data will be available within 12 months of publishing primary results

IPD Sharing Access Criteria

Data use agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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