Mobile Phone Messaging to Improve Reproductive Health for Women Living With HIV in Kenya (Mobile WACh Empower)
Mobile Solutions to Empower Reproductive Life Planning for Women Living With HIV
2 other identifiers
interventional
3,310
1 country
10
Brief Summary
Use of a mobile health (mHealth) intervention to provide reproductive life counseling to women living with HIV may improve delivery of integrated reproductive health/HIV services and prevent adverse reproductive health outcomes. The proposed study will evaluate SMS platform and reproductive health counseling intervention in a cluster randomized controlled trial among women receiving routine HIV care, and plan for future implementation with qualitative and health economic analyses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Dec 2022
Typical duration for not_applicable hiv
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
February 5, 2026
February 1, 2026
3.6 years
February 18, 2022
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contraceptive discontinuation
Proportion not using contraception among women who initiated or continued contraception to prevent pregnancy
2 years
Secondary Outcomes (2)
Uptake of dual methods of contraception
2 years
Unmet need for contraception
2 years
Other Outcomes (2)
Viral load suppression at conception
Up to 2 years
Unintended pregnancy
2 years
Study Arms (2)
Digital counseling plus interactive two-way SMS dialogue
EXPERIMENTALParticipants will receive initial counseling on a tablet followed by automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Control
NO INTERVENTIONControl receiving standard of care.
Interventions
We will utilize a digital counseling tool on a tablet to provide initial reproductive life planning counseling while waiting for an HIV care provider. We will then use Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women following enrollment and for up to 2 years. Women will receive automated theoretically grounded SMS messages targeting the appropriate reproductive health needs and will have the capability to respond and spontaneously message a nurse based at the clinic. . Automated SMS will be delivered at times and in languages based on patient preferences, weekly the first 3 months, every other week in months 4-12, and monthly during the last year of the trial. If there is a change in the reproductive health needs, more frequent messaging will be re-initiated at the same frequency as enrollment.
Eligibility Criteria
You may qualify if:
- HIV-infected
- Receiving HIV care at study site
- Reproductive age (18-45; 14-17 if emancipated minors)
- Daily access to mobile phone (own phone or shared)
- Plan to receive HIV care at enrollment facility for 2 years
- Speak English, Kiswahili, or Luo
- Literate or comfortable with someone reading study SMS
You may not qualify if:
- Currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Bondo sub-County Hospital
Bondo, Kenya
Kisumu District General Hospital
Kisumu, Kenya
Lumumba sub-County Hospital
Kisumu, Kenya
Dandora 2 Health Center
Nairobi, Kenya
Kangemi Health Centre
Nairobi, Kenya
Kenyatta National Hospital
Nairobi, Kenya
Mathare North Health Center
Nairobi, Kenya
Riruta Health Center
Nairobi, Kenya
Rachuonyo District
Oyugis, Kenya
Siaya District Hospital
Siaya, Kenya
Related Publications (1)
Ngumbau N, Unger JA, Wandika B, Atieno C, Beima-Sofie K, Dettinger J, Nzove E, Harrington EK, Karume AK, Osborn L, Sharma M, Richardson BA, Seth A, Udren J, Zanial N, Kinuthia J, Drake AL. Mobile solutions to Empower reproductive life planning for women living with HIV in Kenya (MWACh EMPOWER): Protocol for a cluster randomized controlled trial. PLoS One. 2024 Apr 1;19(4):e0300642. doi: 10.1371/journal.pone.0300642. eCollection 2024.
PMID: 38557692BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alison Drake, PHD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, SPH: Global Health
Study Record Dates
First Submitted
February 18, 2022
First Posted
March 17, 2022
Study Start
December 1, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- At the end of the study, available for 5 years
Data from Mobile WACh Empower will be available at end of the project by contacting the study team at the University of Washington. De-identified data and variables requested.