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

Primary Purpose

mHealth, PMTCT, Adherence, Medication

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
SMS messaging
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for mHealth

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • enrolled in another research study

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Two-way SMS

One-Way SMS

Control

Arm Description

Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse

Participants will receive weekly push SMS messaging

Participants will receive standard of care (no intervention)

Outcomes

Primary Outcome Measures

Maternal Virologic Failure
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.
Retention in Care
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.
Loss to Follow-up
The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression.
Infant HIV-free Survival
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.

Secondary Outcome Measures

Maternal ART Adherence
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.
Maternal ART Resistance
Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.
Maternal Perceptions of Intervention and Care Received
Qualitative interviews at exit

Full Information

First Posted
March 2, 2015
Last Updated
October 31, 2022
Sponsor
University of Washington
Collaborators
University of Nairobi, Kenyatta National Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02400671
Brief Title
Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART
Acronym
Mobile WAChx
Official Title
Evaluation of Mhealth Strategies to Optimize Adherence and Efficacy of PMTCT/ART
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
University of Nairobi, Kenyatta National Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
mHealth, PMTCT, Adherence, Medication, SMS, Maternal Health, HIV/AIDS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
825 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two-way SMS
Arm Type
Experimental
Arm Description
Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse
Arm Title
One-Way SMS
Arm Type
Experimental
Arm Description
Participants will receive weekly push SMS messaging
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive standard of care (no intervention)
Intervention Type
Behavioral
Intervention Name(s)
SMS messaging
Primary Outcome Measure Information:
Title
Maternal Virologic Failure
Description
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.
Time Frame
2 years postpartum
Title
Retention in Care
Description
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.
Time Frame
Assessed at 24 months postpartum
Title
Loss to Follow-up
Description
The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression.
Time Frame
Assessed at 24 months postpartum
Title
Infant HIV-free Survival
Description
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.
Time Frame
2 years postpartum
Secondary Outcome Measure Information:
Title
Maternal ART Adherence
Description
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.
Time Frame
2 years postpartum
Title
Maternal ART Resistance
Description
Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.
Time Frame
2 years postpartum
Title
Maternal Perceptions of Intervention and Care Received
Description
Qualitative interviews at exit
Time Frame
2 years postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years Exclusion Criteria: enrolled in another research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace John-Stewart
Organizational Affiliation
UW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahero District Hospital
City
Ahero
Country
Kenya
Facility Name
Bondo District Hospital
City
Bondo
Country
Kenya
Facility Name
Mathare City Council Clinic
City
Nairobi
Country
Kenya
Facility Name
Riruta Health Centre
City
Nairobi
Country
Kenya
Facility Name
Rachuonyo sub-County Hospital
City
Oyugis
Country
Kenya
Facility Name
Siaya County Referral Hospital
City
Siaya
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
28315480
Citation
Drake AL, Unger JA, Ronen K, Matemo D, Perrier T, DeRenzi B, Richardson BA, Kinuthia J, John-Stewart G. Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: Rationale, design and methods of a 3-armed randomized controlled trial. Contemp Clin Trials. 2017 Jun;57:44-50. doi: 10.1016/j.cct.2017.03.007. Epub 2017 Mar 14.
Results Reference
background
PubMed Identifier
29254362
Citation
Ronen K, Unger JA, Drake AL, Perrier T, Akinyi P, Osborn L, Matemo D, O'Malley G, Kinuthia J, John-Stewart G. SMS messaging to improve ART adherence: perspectives of pregnant HIV-infected women in Kenya on HIV-related message content. AIDS Care. 2018 Apr;30(4):500-505. doi: 10.1080/09540121.2017.1417971. Epub 2017 Dec 18.
Results Reference
background
PubMed Identifier
31752872
Citation
Lewis K, Harrington EK, Matemo D, Drake AL, Ronen K, O'Malley G, Kinuthia J, John-Stewart G, Unger JA. Utilizing perspectives from HIV-infected women, male partners and healthcare providers to design family planning SMS in Kenya: a qualitative study. BMC Health Serv Res. 2019 Nov 21;19(1):870. doi: 10.1186/s12913-019-4708-7.
Results Reference
background
PubMed Identifier
30026177
Citation
Fairbanks J, Beima-Sofie K, Akinyi P, Matemo D, Unger JA, Kinuthia J, O'Malley G, Drake AL, John-Stewart G, Ronen K. You Will Know That Despite Being HIV Positive You Are Not Alone: Qualitative Study to Inform Content of a Text Messaging Intervention to Improve Prevention of Mother-to-Child HIV Transmission. JMIR Mhealth Uhealth. 2018 Jul 19;6(7):e10671. doi: 10.2196/10671.
Results Reference
background
PubMed Identifier
34579601
Citation
Osborn L, Ronen K, Larsen AM, Richardson B, Khasimwa B, Chohan B, Matemo D, Unger J, Drake AL, Kinuthia J, John-Stewart G. Antenatal depressive symptoms in Kenyan women living with HIV: contributions of recent HIV diagnosis, stigma, and partner violence. AIDS Care. 2022 Jan;34(1):69-77. doi: 10.1080/09540121.2021.1981216. Epub 2021 Sep 27.
Results Reference
derived
PubMed Identifier
34029338
Citation
Kinuthia J, Ronen K, Unger JA, Jiang W, Matemo D, Perrier T, Osborn L, Chohan BH, Drake AL, Richardson BA, John-Stewart G. SMS messaging to improve retention and viral suppression in prevention of mother-to-child HIV transmission (PMTCT) programs in Kenya: A 3-arm randomized clinical trial. PLoS Med. 2021 May 24;18(5):e1003650. doi: 10.1371/journal.pmed.1003650. eCollection 2021 May.
Results Reference
derived

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

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