Atukunda Esther Cathyln, Mugyenyi Godfrey Rwambuka, Haberer Jessica E, Siedner Mark J, Musiimenta Angella, Najjuma Josephine N, Obua Celestino, Matthews Lynn T
Mbarara University of Science and Technology, Mbarara, Uganda.
Department of Medicine and Center for Global Health, Harvard Medical School, Massachusetts General Hospital, Boston, MA, United States.
JMIR Res Protoc. 2025 Mar 19;14:e67049. doi: 10.2196/67049.
Mobile health (mHealth) interventions that leverage social support (SS) can improve partner involvement and pregnancy experiences and promote antenatal care (ANC) attendance and skilled births. In our previous studies, we used behavioral frameworks to develop a user-centered mHealth-based, audio SMS text messaging app to support pregnant individuals to use maternity care services in rural Uganda (Support-Moms app). In our pilot study, we observed high intervention uptake, acceptability, and feasibility, as well as increased ANC attendance and skilled births.
With the promising pilot data, we propose a type 1 hybrid implementation-effectiveness trial to test if this novel patient-centered automated and customized mHealth-based SS intervention is effective and cost-effective enough to warrant future large-scale implementation into Uganda's routine maternity care.
We will physically recruit 824 pregnant women at <20 weeks of gestation living in Mbarara and Mitooma districts, southwestern Uganda, and randomize them (1:1) to receive standard of care or the Support-Moms app, with at least 2 of their identified social supporters. Our primary outcome will be the proportion of skilled births. Secondary outcomes will include number of ANC visits, institution-based delivery, mode of infant delivery, preterm birth, birth weight, SS, obstetric complications, and deaths (maternal, fetal, and newborn). We will assess other implementation, service, and client outcomes through study records, the mHealth platform, and questionnaires with all women in the intervention, their social supporters, health care providers (HCPs), and managers from participating facilities. We will conduct face-to-face in-depth exit interviews with 30 purposively selected intervention participants and 15 facility HCPs and managers to explore implementation strategies for scale-up. Annual maternity resource allocations, costs, number of ANC visits, and deliveries will be assessed from facility records up to 36 months after implementation. We will estimate incremental cost-effectiveness ratios concerning cost per additional HCP-led delivery, per death averted, and per quality-adjusted life year gained as cost-effectiveness measures.
This study was funded in September 2023. Ethics approval was obtained in February 2024, and actual data collection started in March 2024. As of January 2025, 75% (618/824) of all projected study participants provided consent and were recruited into the study. Participants are expected to be followed up until delivery, and 15% (124/824) have so far exited. Data analysis for the trial is expected to start as soon as the last participant exits from the study. The qualitative interviews will start in April 2025, and data will be analyzed and published as soon as data collection is done, which is expected in March 2027.
We are testing the feasibility, acceptability, and cost-effectiveness of implementing Support-Moms into routine maternity care from individual and facility perspectives. We hypothesize that Support-Moms will be an effective and cost-effective strategy to improve maternity service use for women in rural Uganda and similar settings.
ClinicalTrials.gov NCT05940831; https://clinicaltrials.gov/study/NCT05940831.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67049.
利用社会支持（SS）的移动健康（mHealth）干预措施可以提高伴侣参与度和孕期体验，并促进产前护理（ANC）的就诊率和熟练接生率。在我们之前的研究中，我们使用行为框架开发了一款以用户为中心的基于移动健康的音频短信应用程序，以支持乌干达农村地区的孕妇使用孕产妇保健服务（支持妈妈应用程序）。在我们的试点研究中，我们观察到该干预措施的高采用率、可接受性和可行性，以及增加的产前护理就诊率和熟练接生率。
基于有前景的试点数据，我们提出一项1型混合实施-效果试验，以测试这种新型的以患者为中心的自动化和定制化移动健康社会支持干预措施是否有效且具有成本效益，足以保证未来在乌干达的常规孕产妇保健中大规模实施。
我们将实际招募824名妊娠小于20周、居住在乌干达西南部姆巴拉拉和米托马区的孕妇，并将她们随机分为两组（1:1），一组接受标准护理，另一组使用支持妈妈应用程序，并至少有2名她们确定的社会支持者。我们的主要结局将是熟练接生率。次要结局将包括产前护理就诊次数、机构分娩、婴儿分娩方式、早产、出生体重、社会支持、产科并发症和死亡（孕产妇、胎儿和新生儿）。我们将通过研究记录、移动健康平台以及对干预组所有女性、她们的社会支持者、医疗保健提供者（HCPs）和参与机构的管理人员进行问卷调查，来评估其他实施、服务和客户结局。我们将对30名有目的地选择的干预参与者以及15名机构医疗保健提供者和管理人员进行面对面的深入退出访谈，以探索扩大规模的实施策略。将从实施后长达36个月的机构记录中评估年度孕产妇资源分配、成本、产前护理就诊次数和分娩次数。作为成本效益衡量指标，我们将估计每增加一次由医疗保健提供者主导的分娩、每避免一例死亡以及每获得一个质量调整生命年的增量成本效益比。
本研究于2023年9月获得资助。2024年2月获得伦理批准，实际数据收集于2024年3月开始。截至2025年1月，所有预计研究参与者中的75%（618/824）提供了同意并被纳入研究。预计对参与者进行随访直至分娩，到目前为止已有15%（124/824）退出。预计一旦最后一名参与者退出研究，试验的数据分析将立即开始。定性访谈将于2025年4月开始，数据收集完成后将立即进行分析和发表，预计在2027年3月完成。
我们正在从个体和机构的角度测试将支持妈妈应用程序纳入常规孕产妇保健的可行性、可接受性和成本效益。我们假设支持妈妈应用程序将是一种有效且具有成本效益的策略，可改善乌干达农村地区及类似环境中妇女的孕产妇服务利用情况。
ClinicalTrials.gov NCT05940831；https://clinicaltrials.gov/study/NCT05940831。
国际注册报告识别号（IRRID）：DERR1-10.2196/67049。
