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

Primary Purpose

HIV/AIDS, Adherence

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
SMS Reminders
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring HIV/AIDS, adherence, women, real time monitoring, risk, SMS, mHealth

Eligibility Criteria

18 Years - 24 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • KEMRI
  • KEMRI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMS Reminders

No Reminders

Arm Description

Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.

Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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

Full Information

First Posted
September 16, 2016
Last Updated
May 29, 2023
Sponsor
Massachusetts General Hospital
Collaborators
University of Washington, Kenya Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02915367
Brief Title
Monitoring Pre-exposure Prophylaxis for Young Adult Women
Acronym
MPYA
Official Title
Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2016 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
University of Washington, Kenya Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Adherence
Keywords
HIV/AIDS, adherence, women, real time monitoring, risk, SMS, mHealth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS Reminders
Arm Type
Experimental
Arm Description
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
Arm Title
No Reminders
Arm Type
No Intervention
Arm Description
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.
Intervention Type
Behavioral
Intervention Name(s)
SMS Reminders
Intervention Description
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).
Primary Outcome Measure Information:
Title
Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
Description
Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.
Time Frame
up to 2 years follow-up
Secondary Outcome Measure Information:
Title
Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring
Description
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)
Time Frame
Month 1
Title
USD Per Month
Description
Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted
Time Frame
two years
Other Pre-specified Outcome Measures:
Title
Risk Perception
Description
Assess self-reported weekly HIV risk perception through an automated SMS survey
Time Frame
up to 2 years follow-up
Title
Adherence Measure Performance
Description
Tenofovir concentration in DBS compared to electronic adherence data from the prior 30 days for each participant.
Time Frame
up to 2 years follow-up
Title
Pregnancy Outcomes
Description
Descriptive measures of infants exposed to PrEP during gestation
Time Frame
6 months post-partum or end of the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Haberer, MD, MS
Organizational Affiliation
Massachussetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jared Baeten, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nelly Mugo
Organizational Affiliation
Kenya Medical Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elizabeth Bukusi
Organizational Affiliation
Kenya Medical Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
KEMRI
City
Kisumu
Country
Kenya
Facility Name
KEMRI
City
Thika
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35147580
Citation
Haberer JE, Mugo N, Bukusi EA, Ngure K, Kiptinness C, Oware K, Garrison LE, Musinguzi N, Pyra M, Valenzuela S, Thomas KK, Anderson PL, Thirumurthy H, Baeten JM. Understanding Pre-Exposure Prophylaxis Adherence in Young Women in Kenya. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):251-260. doi: 10.1097/QAI.0000000000002876.
Results Reference
derived
PubMed Identifier
33662265
Citation
Haberer JE, Bukusi EA, Mugo NR, Pyra M, Kiptinness C, Oware K, Garrison LE, Thomas KK, Musinguzi N, Morrison S, Anderson PL, Ngure K, Baeten JM; MPYA Study Team. Effect of SMS reminders on PrEP adherence in young Kenyan women (MPYA study): a randomised controlled trial. Lancet HIV. 2021 Mar;8(3):e130-e137. doi: 10.1016/S2352-3018(20)30307-6.
Results Reference
derived

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Monitoring Pre-exposure Prophylaxis for Young Adult Women

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