Clinical trial NCT05940831: Mobile Health Intervention (Support-moms) in Antenatal Care to Improve Maternal Health in Uganda
Official title: Integration of a Patient-centered Mobile Health Intervention (Support-moms) Into Routine Antenatal Care to Improve Maternal Health in Uganda.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Health
Keywords: mhealth
antenatal care
social support
healthcare utilization
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Harvard Medical School (HMS and HSDM)
name: Massachusetts General Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-07-11
Enrollment: 1680
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Healthcare provider (HCP)-led skilled births
timeFrame: 15 months
Secondary outcomes:
measure: Maternal, implementation, service and client outcomes
timeFrame: 15 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara city
city: Mbarara
country: Uganda
facility: Mbarara district
Study officials:
affiliation: Mbarara University of Science and Technology
name: Esther C. Atukunda, PhD
role: PRINCIPAL_INVESTIGATOR
References: