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临床试验/NCT02999334
NCT02999334已完成不适用

HIV With Innovative Group Antenatal Care in Two African Countries

University of Illinois at Chicago0 个研究点目标入组 218 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
218
主要终点
Adherence to Care

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Physically and mentally competent pregnant women over the age of 16 attending antenatal care

排除标准

  • Less than 16 years of age

结局指标

主要结局

Adherence to Care

时间窗: 6-8 weeks postpartum

Two Indicators: Attended 4 (or more) antenatal care visits (yes, no) and the 6-week postnatal visit (yes, no)

次要结局

  • Comprehensive HIV Prevention Knowledge(Enrollment, 32-40 weeks gestation)
  • Any Adverse Perinatal Event(6-8 weeks postpartum)
  • Healthy Pregnancy Knowledge Index(Enrollment, 32-40 weeks gestation)
  • Satisfaction with Care(32-40 weeks gestation)
  • Healthy Pregnancy Behaviors(Enrollment, 32-40 weeks gestation)
  • Prevention of Mother-to-Child (PMTCT) Knowledge(Enrollment, 32-40 weeks gestation)
  • Pregnancy-Related Empowerment Scale (PRES)(32-40 weeks gestation)
  • Mental Distress(Enrollment, 32-40 weeks gestation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Crystal L. Patil, PhD

Associate Professor

University of Illinois at Chicago

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