Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05940831 |
Other study ID # |
MUST-2023-06-29 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 2023 |
Est. completion date |
July 2028 |
Study information
Verified date |
July 2023 |
Source |
Mbarara University of Science and Technology |
Contact |
Esther C. Atukunda, PhD |
Phone |
+256 782949832 |
Email |
eatukunda[@]must.ac.ug |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.