Prenatal Care Clinical Trial
Official title:
HIV With Innovative Group Antenatal Care in Two African Countries
The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe resource and staffing shortages. The investigators adapted and piloted an evidence-based model of group antenatal care as an innovative way to improve ANC service delivery and increase health promotion. This pilot will be conducted in Malawi and Tanzania and will provide data to prepare for a large randomized controlled trial to document the impacts that group antenatal has on perinatal health outcomes. This study will ultimately inform policy and practice aimed at improving quality of antenatal care through respectful and woman-centered care to pregnant women.
More than 90% of women in sub-Saharan Africa use antenatal care (ANC) at least once in
pregnancy. To leverage high attendance rates, most facilities bundle HIV prevention and
prevention of maternal-to-child transmission (PMTCT) with ANC. Unfortunately, the quality of
ANC in sub-Saharan Africa is sharply constrained by severe resource and staffing shortages,
as reflected in numerous "missed opportunities" for PMTCT, clinical service delivery, and
health education. Moreover, job satisfaction among the overburdened providers is low. To
improve ANC quality, the investigators will adapt and pilot an innovative, evidence-based
model of group ANC, an approach that restructures provider time, allowing health facilities
to offer respectful, woman-centered and high quality ANC given the limitations.
In CenteringPregnancy (CP), the only evidence-based model of group ANC, 12 women meet
jointly for two hour antenatal visits, assessing their own weights and blood pressures,
meeting briefly with the provider for individual consultations, and engaging in facilitated
health discussions. Randomized controlled trial (RCT) data from ethnically and
socioeconomically diverse populations in the US demonstrated that CP is highly effective at
improving ANC adherence, provider and client satisfaction, and maternal and child outcomes.
In the US, the successful integration of HIV prevention into the CP model reduced sexually
transmitted infections and increased condom use.
CP has not been implemented with fidelity and tested for efficacy in a low-resource country.
With funding from the Chicago Developmental Center for AIDS Research, the investigators
conducted preliminary work in Malawi and Tanzania which suggested that a CP-based model of
group ANC was feasible and acceptable; both women and providers were excited and energized
by the model. The purpose of this study is to build on this work and: 1) conduct the
developmental work to collaboratively adapt CP materials for use in both countries
(sessions, training guides, and implementation and evaluation strategies); 2) train
providers and pretest activities; and 3) conduct a full-scale randomized pilot.
Investigators will work directly with the Centering Healthcare Institute to implement this
CP-based model of group ANC with fidelity. This study will result in a feasible, acceptable,
and sustainable CP-based model of group ANC adapted for the constraints posed by poorly
resourced health systems and those of the clients they serve. These pilot data will be used
to generate retention rates and effect sizes for an RCT to test the efficacy of a CP-based
group ANC model.
Group antenatal care is an innovative paradigm shift in ANC, and this rigorous evaluation of
its impact will expand the limited scientific assessments of reconfigured ANC models and
mother and infant health outcomes in low-resource countries in sub-Saharan Africa. Because
this model was developed and tested in target countries with high HIV prevalence and poor
maternal and neonatal outcomes, it has the potential for broad impacts on maternal and child
health, including PMTCT, in other low resource settings.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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