NCT05940831

Brief Summary

High maternal mortality is a major public health problem in many settings. Because of low antenatal care (ANC) and skilled birth usage, Ugandan women and their children suffer from high maternal and perinatal mortality. The investigators developed a promising intervention (Support-Moms app) that shares targeted health information, and engages social support networks through scheduled reminders to help support pregnant women to utilize maternity services in rural Uganda. The investigators now propose to test and implement the Support-Moms intervention and hypothesize that Support-Moms will be feasible and cost-effective in improving utilization of available maternity care services, and ultimately reduce maternal and perinatal mortality.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,680

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress47%
May 2024Jul 2028

First Submitted

Initial submission to the registry

June 30, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2028

Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

3.8 years

First QC Date

June 30, 2023

Last Update Submit

August 2, 2024

Conditions

Keywords

mhealthantenatal caresocial supporthealthcare utilization

Outcome Measures

Primary Outcomes (1)

  • Healthcare provider (HCP)-led skilled births

    Proportion of individuals delivering with the help of a healthcare provider (HCP)

    15 months

Secondary Outcomes (1)

  • Maternal, implementation, service and client outcomes

    15 months

Study Arms (2)

Intervention

EXPERIMENTAL

Scheduled SMS-audio messages from the final messaging prototype (SM), messages, plus social supporter engagement through SMS (SS)

Behavioral: Support-Moms

Control

ACTIVE COMPARATOR

Routine care/ information giving

Behavioral: Control

Interventions

Support-MomsBEHAVIORAL

Scheduled SMS-audio messages from the final messaging prototype (SM), plus social supporter engagement through SMS (SS).

Intervention
ControlBEHAVIORAL

Routine care/ information giving

Control

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who:
  • are in the first trimester of pregnancy who have not yet presented for ANC
  • reside in the catchment area of a study HC
  • are emancipated minors and adults aged ≥ 18 years
  • report access to a cell phone with reception in their home
  • are able to identify at least two social supporters living within the study districts
  • are able to provide consent.
  • are from participants' existing social support network, with whom they have had stable, long-term relationships

You may not qualify if:

  • Participants will be excluded from the study if they:
  • do not own a cell phone for personal use with reported reliable reception
  • are unable to use SMS or unwilling to receive SMS notifications
  • Potential social supporters will be excluded from the study if they:
  • are under 18 years of age
  • do not own a cell phone for personal use with reported reliable reception
  • are unable to use SMS or unwilling to receive SMS notifications
  • have not had stable, long-term relationships with the participants
  • are not aware that the study participant is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mbarara city

Mbarara, Uganda

RECRUITING

Mbarara district

Mbarara, Uganda

RECRUITING

Related Publications (1)

  • Atukunda EC, Mugyenyi GR, Haberer JE, Siedner MJ, Musiimenta A, Najjuma JN, Obua C, Matthews LT. Integration of a Patient-Centered mHealth Intervention (Support-Moms) Into Routine Antenatal Care to Improve Maternal Health Among Pregnant Women in Southwestern Uganda: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 19;14:e67049. doi: 10.2196/67049.

Study Officials

  • Esther C. Atukunda, PhD

    Mbarara University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther C. Atukunda, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 11, 2023

Study Start

May 1, 2024

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

July 30, 2028

Last Updated

August 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Sufficient patient/participant and facility data from this project will be preserved and shared to validate and replicate research findings described in our Aims. We are aware of the policies and guidelines established by NIH for Data Management and Strategy, and we intend to release and share all final research data and materials from this NIH-supported study for use by other researchers in a timely manner. We will endeavour to make accessible, the research tools to other researchers under reasonable terms and conditions promoting free competition and enterprise and reflecting dual obligations of disseminating unique research resources. The privacy and confidentiality of participants will be safeguarded at all time.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Ongoing
Access Criteria
Password protected through RedCap

Locations