- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940831
Mobile Health Intervention (Support-moms) in Antenatal Care to Improve Maternal Health in Uganda (Support-Moms)
Integration of a Patient-centered Mobile Health Intervention (Support-moms) Into Routine Antenatal Care to Improve Maternal Health in Uganda.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Antenatal care (ANC) and skilled births are mainstays of preventing maternal and perinatal morbidity and mortality. Despite expanded availability of skilled birth attendants and referral health systems, Ugandan women have low ANC use and skilled births, resulting in one of the highest maternal mortality ratios and perinatal mortality rates in the world. Mobile health (mHealth) interventions can support individuals to internalize risks, need, and benefits of health services with high intervention delivery success. Provision of multiple messaging approaches-such as scheduled SMS, telephone voice messages and social support engagement-can empower individuals to seek and access care, and improve health outcomes. However, despite successes in pilot studies, there is little data on effectiveness, appropriateness, feasibility, fidelity and incremental costs needed to adopt, or scale up such strategies in sub-Saharan Africa, where the public health impact of such interventions is likely to be the greatest.
As part of a K43 career development award (PI Atukunda), the investigators used behavioral frameworks to develop a user-centered mHealth-based, audio-SMS messaging application to support pregnant individuals to use maternity care services in rural Uganda (Support-Moms app). The app shared health-related information and engaged social support networks via scheduled SMS/audio reminders and upcoming ANC appointment notifications. In a randomized 3-arm pilot study (n=120) comparing standard of care (SOC), scheduled messaging (SM), and scheduled messaging plus social supporter engagement (SS), the investigators observed high intervention uptake, acceptability, and feasibility. All women whose social supporters were engaged on the app attended ≥4 ANC visits, compared to 83% and 50% of women receiving only messages and SOC, respectively. Nearly all women in the SS arm (98%) had a skilled delivery compared to 78% and 70% in SM and SOC groups, respectively. The investigators now propose a type 1 hybrid implementation-effectiveness trial to evaluate and implement the Support-Moms intervention into routine care. The investigators will test the effectiveness of the intervention in a randomized controlled trial (N=824); the primary outcome will be the proportion of healthcare provider-led skilled births (Aim 1). The investigators will apply Proctor's implementation outcomes framework to evaluate implementation, service and client outcomes, and conduct in-depth interviews with users and key stakeholders to contextualize/clarify these outcomes, and explore implementation strategies for future scale-up using the Consolidated Framework for Implementation Research (CFIR) (Aim 2). They will assess costs and cost-effectiveness of implementing Support-Moms into routine care (Aim 3). The investigators hypothesize that Support-Moms will be an effective and cost-effective strategy to improve maternity service utilization.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esther C. Atukunda, PhD
- Phone Number: +256 782949832
- Email: eatukunda@must.ac.ug
Study Contact Backup
- Name: Arnold Mindra, MSc
- Phone Number: +256 774885355
- Email: mindra.arnold@must.ac.ug
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Scheduled SMS-audio messages from the final messaging prototype (SM), messages, plus social supporter engagement through SMS (SS)
|
Scheduled SMS-audio messages from the final messaging prototype (SM), plus social supporter engagement through SMS (SS).
|
Active Comparator: Control
Routine care/ information giving
|
Routine care/ information giving
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare provider (HCP)-led skilled births
Time Frame: 15 months
|
Proportion of individuals delivering with the help of a healthcare provider (HCP)
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal, implementation, service and client outcomes
Time Frame: 15 months
|
Proportion of individuals who report the following outcomes: a) number of ANC visits, b) institution-based delivery, c) social support d) mode of infant delivery, e) all deaths (maternal, fetal, newborn), f) preterm birth, g) birth weight, h) breastfeeding, i) completion of post-natal care, j) complications of pregnancy and childbirth (e.g obstructed labor, ruptured uterus, need for neonatal or maternal resuscitation/ assisted ventilation, severe preeclampsia/ eclampsia, postpartum hemorrhage (PPH), maternal/newborn sepsis, and other infections); and implementation, service and client outcomes
|
15 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Esther C. Atukunda, PhD, Mbarara University of Science and Technology
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MUST-2023-06-29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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