Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART (Mobile WAChx)

October 31, 2022 updated by: Grace John-Stewart, University of Washington

Evaluation of Mhealth Strategies to Optimize Adherence and Efficacy of PMTCT/ART

The investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: "push" messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will compare trial arms for impact on maternal retention, adherence, virologic failure and resistance and infant HIV or HIV-free survival.

The investigators will determine correlates of maternal loss to follow-up and virologic failure and correlates of infant HIV in the overall study and stratified by trial arm. In the bidirectional SMS arm, the investigators will determine the rate of SMS interactivity, impact of critical time-points on messaging, and characteristics of high and low 'interactors'.

The investigators will determine cost-effectiveness of unidirectional and bidirectional SMS interventions. These data will contribute a potential scale-able strategy to improve PMTCT-ART as programs aspire to 'virtual elimination' of infant HIV.

Study Type

Interventional

Enrollment (Actual)

825

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
      • Ahero, Kenya
        • Ahero District Hospital
      • Bondo, Kenya
        • Bondo District Hospital
      • Nairobi, Kenya
        • Mathare City Council Clinic
      • Nairobi, Kenya
        • Riruta Health Centre
      • Oyugis, Kenya
        • Rachuonyo sub-County Hospital
      • Siaya, Kenya
        • Siaya County Referral Hospital

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years

Exclusion Criteria:

  • enrolled in another research 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Two-way SMS
Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse
Behavioral: SMS messaging
Experimental: One-Way SMS
Participants will receive weekly push SMS messaging
Behavioral: SMS messaging
No Intervention: Control
Participants will receive standard of care (no intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Virologic Failure
Time Frame: 2 years postpartum
Prevalence of virologic failure (HIV RNA ≥1000 c/ml) after the first 4 months post-ART will be compared between study arms using Generalized Estimating Equations (GEE) with log-binomial link.
2 years postpartum
Retention in Care
Time Frame: Assessed at 24 months postpartum
Timely clinic visit attendance during follow-up from enrollment in pregnancy to 12 and 24 months postpartum will be compared between study arms using GEE with log-binomial link.
Assessed at 24 months postpartum
Loss to Follow-up
Time Frame: Assessed at 24 months postpartum
The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression.
Assessed at 24 months postpartum
Infant HIV-free Survival
Time Frame: 2 years postpartum
Incidence of infant HIV acquisition or death (events per person-time of follow-up) will be compared between study arms using Cox proportional hazards regression.
2 years postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal ART Adherence
Time Frame: 2 years postpartum
ART adherence, defined as the proportion of days "covered" by ART between pharmacy refills, will be dichotomized and compared between arms using GEE with log-binomial link.
2 years postpartum
Maternal ART Resistance
Time Frame: 2 years postpartum
Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.
2 years postpartum
Maternal Perceptions of Intervention and Care Received
Time Frame: 2 years postpartum
Qualitative interviews at exit
2 years postpartum

Collaborators and Investigators

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

Sponsor

University of Washington

Collaborators

University of Nairobi
Kenyatta National Hospital

Investigators

  • Principal Investigator: Grace John-Stewart, UW

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)

November 1, 2015

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000916

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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