NCT05369806

Brief Summary

Mobile health (mHealth) interventions such as interactive short message service (SMS) text messaging with healthcare workers (HCWs) have been proposed as efficient, accessible additions to traditional health care in resource-limited settings. Realizing the full public health potential of mHealth for maternal health requires use of new technological tools that dynamically adapt to user needs. This study will test use of a natural language processing computer algorithm on incoming SMS messages with pregnant people and new mothers in Kenya to see if it can help to identify urgent messages.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

April 11, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

May 4, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 29, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

April 11, 2022

Results QC Date

December 7, 2023

Last Update Submit

December 22, 2023

Conditions

Keywords

KenyaSMSNatural Language ProcessingNLPmHealth

Outcome Measures

Primary Outcomes (2)

  • Acceptability

    AIM (Acceptability of Intervention Measure) score (Weiner et al instrument. Score range 1-5; higher score indicates higher acceptability)

    Enrollment through 4 weeks postpartum

  • Nurse Response Time

    Minutes from urgent participant message to nurse response

    Enrollment through 4 weeks postpartum

Study Arms (1)

Interactive two-way SMS dialogue

EXPERIMENTAL

Participants will receive 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. The NLP model will be applied to messages and will highlight those determined to be urgent.

Behavioral: Interactive two-way SMS dialogue

Interventions

This study uses Mobile WACh, a human-computer hybrid system that enables two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day. Women who experience pregnancy or infant loss will be enrolled into an infant loss track. The NLP model will be applied to incoming participant messages. Those flagged as urgent by the model will be flagged within the SMS system, allowing study nurses to triage and appropriately respond to those messages.

Interactive two-way SMS dialogue

Eligibility Criteria

Age14 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant
  • ≥28 weeks gestation
  • Daily access to a mobile phone (own or shared) on the Safaricom network
  • Willing to receive SMS
  • Age ≥14 years
  • Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the household who can help

You may not qualify if:

  • Currently enrolled in another research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahero Sub-District Hospital

Ahero, Kisumu County, Kenya

Location

Kisumu County Hospital

Kisumu, Kenya

Location

MeSH Terms

Conditions

Perinatal DeathDepression

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Results Point of Contact

Title
Keshet Ronen
Organization
University of Washington

Study Officials

  • Keshet Ronen, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: All participants are enrolled into the MWACh SMS system
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Acting Assistant Professor, School of Public Health: Global Health

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 11, 2022

Study Start

May 4, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

December 29, 2023

Results First Posted

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Data from AI-NEO will be available at end of the project by contacting the study team at the University of Washington (keshet@uw.edu).

Time Frame
End of project

Locations