Maternal HealthSupport-MomsNCT05940831
Mobile Health Intervention (Support-moms) in Antenatal Care to Improve Maternal Health in Uganda
A study testing Support-Moms in people with Maternal Health, run by Mbarara University of Science and Technology at 2 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Maternal Health
- What is being tested?
- Support-Moms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,680 participants
- Where
- 2 sitesUganda
- Study dates
- 1 May 2024to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda2 sites, 2 recruiting
- Recruiting
Mbarara city
Mbarara
Esther C Atukunda, PhD, +256 782949832, eatukunda@must.ac.ug
- Recruiting
Mbarara district
Mbarara
Esther C Atukunda, PhD, +256 782949832, eatukunda@must.ac.ug
About this study
Official title: Integration of a Patient-centered Mobile Health Intervention (Support-moms) Into Routine Antenatal Care to Improve Maternal Health in Uganda.
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.
Read the 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.
- Conditions
- Maternal Health
- Being tested
- Support-Moms, Control
- Keywords
- mhealth, antenatal care, social support, healthcare utilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support-MomsBehavioural
Scheduled SMS-audio messages from the final messaging prototype (SM), plus social supporter engagement through SMS (SS).
ControlBehavioural
Routine care/ information giving
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Scheduled SMS-audio messages from the final messaging prototype (SM), messages, plus social supporter engagement through SMS (SS) Receives: Behavioral: Support-Moms |
| Control | Active comparator | Routine care/ information giving Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare provider (HCP)-led skilled births
Proportion of individuals delivering with the help of a healthcare provider (HCP)
Measured: 15 months
Secondary outcomes (1)
Maternal, implementation, service and client outcomes
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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 May 2024
- Primary completion29 Feb 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Harvard Medical School (HMS and HSDM), Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Esther C. Atukunda, PhD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940831
- Sponsor's protocol ID
- MUST-2023-06-29
- Other IDs
- 1R01HD111692-01
- Acronym
- Support-Moms
- Status last verified
- Aug 2024
- First submitted
- 30 Jun 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Atukunda EC, Mugyenyi GR, Haberer J, Nghiem VT, Atuhumuza EB, Waiswa P, Musiimenta A, Kanyesigye M, Obua C, Siedner MJ, Matthews LT. An mHealth-based social support program to improve antenatal care engagement and facility-based births in Uganda: A type I hybrid effectiveness-implementation clinical trial. medRxiv [Preprint]. 2026 Apr 30:2026.04.28.26351943. doi: 10.64898/2026.04.28.26351943.
PubMed 42094170Atukunda 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.
PubMed 40105879
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of a Patient-centered Mobile Health Intervention (Support-moms) Into Routine Antenatal Care to Improve Maternal Health in Uganda.
- ClinicalTrials.gov ID
- NCT05940831
- Acronym / sponsor ID
- Support-Moms / MUST-2023-06-29
- Conditions
- Maternal Health
- Keywords
- mhealth, antenatal care, social support, healthcare utilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,680 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Harvard Medical School (HMS and HSDM), Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Support-MomsScheduled SMS-audio messages from the final messaging prototype (SM), messages, plus social supporter engagement through SMS (SS) |
| Control | Active comparator | Behavioral: ControlRoutine care/ information giving |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- do not own a cell phone for personal use with reported reliable reception
- are unable to use SMS or unwilling to receive SMS notifications
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support-MomsScheduled SMS-audio messages from the final messaging prototype (SM), plus social supporter engagement through SMS (SS). | Behavioural | Intervention |
| ControlRoutine care/ information giving | Behavioural | Control |
Primary outcome
Healthcare provider (HCP)-led skilled births
Time frame: 15 months
Proportion of individuals delivering with the help of a healthcare provider (HCP)
1 secondary outcome
Maternal, implementation, service and client outcomes
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Derived from this study: PubMed 42094170Atukunda EC, Mugyenyi GR, Haberer J, Nghiem VT, Atuhumuza EB, Waiswa P, Musiimenta A, Kanyesigye M, Obua C, Siedner MJ, Matthews LT. An mHealth-based social support program to improve antenatal care engagement and facility-based births in Uganda: A type I hybrid effectiveness-implementation clinical trial. medRxiv [Preprint]. 2026 Apr 30:2026.04.28.26351943. doi: 10.64898/2026.04.28.26351943.
- Derived from this study: PubMed 40105879Atukunda 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esther C. Atukunda, PhD principal investigator
Mbarara University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support-Moms in people with Maternal Health, run by Mbarara University of Science and Technology at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther C. Atukunda, PhD (+256 782949832, eatukunda@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare provider (HCP)-led skilled births (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05940831, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.