Skip to main content
OpenTrials
Completed

NCT Number: NCT02915367

Monitoring Pre-exposure Prophylaxis for Young Adult Women

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Adherence Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KEMRI, Kisumu, Kenya

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMS reminders

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

Other outcomes

  1. Risk Perception

    Time frame: up to 2 years follow-up

    Assess self-reported weekly HIV risk perception through an automated SMS survey

  2. 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.

  3. Pregnancy Outcomes

    Time frame: 6 months post-partum or end of the study

    Descriptive measures of infants exposed to PrEP during gestation

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Kenya Medical Research Institute
  • University of Washington

Registry information

Official study title

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

Acronym: MPYA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2016
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.