A Non-randomized Comparative Cohort Study Evaluating a Home-based Community Health Worker Program in the Rural Eastern Cape Province of South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,490
- 试验地点
- 2
- 主要终点
- Composite outcome: Number of significantly improved child and maternal outcomes
研究概览
简要总结
The purpose of this early Phase 2 comparison trial is to evaluate the impact of community health worker (CHW) home visitors on pregnant women and their children in a rural setting in the rural Eastern Cape of South Africa. The intervention provided by the CHWs targets underweight children, mothers living with HIV (MLH), mothers using alcohol, and depressed mothers with the goal of supporting pregnant women to improve birth outcomes, decrease the number of children born with a low birthweight, and develop child caretaking skills over time. UCLA has identified and matched four areas surrounding primary health care clinics: two intervention areas in which this CHW program has been running for one year, and two control areas without the program. Mothers in the research area are followed for one year after giving birth.
详细描述
Inequalities in the quality and accessibility of healthcare between urban centers and rural areas is a global challenge that is particularly stark for low and middle-income countries (LMIC). Maternal and child health (MCH) in rural South Africa is negatively impacted by large distances, poor infrastructure, and a shortage of healthcare workers at clinics and hospitals.
Home visiting has been repeatedly demonstrated efficacious in addressing some of these challenges and improving MCH outcomes, including when delivered by CHW in LMIC. However, there is limited research on the effectiveness of implementing these types of programs in rural areas.
The investigators have shown that with training, supervision, and accountability, CHW home visits are effective in improving MCH over the first five years of life. These results were observed in a successful randomized controlled trial conducted in peri-urban townships in Cape Town, South Africa. CHW were trained to address HIV, alcohol, and malnutrition among all pregnant women in a neighborhood, to avoid stigma, and to address multiple health challenges concurrently. The visits significantly improved MCH outcomes over five years. Based on these results, this comprehensive CHW home visiting program served as one model for re-engineering primary health care to include 65,000 paraprofessionals providing home-based care in South Africa.
This early phase two comparison trial examines whether the same comprehensive CHW home visiting program can be effectively implemented in a deeply rural area of the Eastern Cape in South Africa. Two matched cohorts of women and their children, one in areas where the comprehensive CHW program has been active for one year and one in areas without the program, will be followed from pregnancy through the first 12 months after giving birth. Stellenbosch University interviewers will independently assess outcomes of each mother at pregnancy, and of the mothers and infants within two weeks of post-birth, 6 months, and 12 months later. The primary outcomes are a combined measures of maternal and child health including maternal HIV testing, depression, and alcohol use, as well as the child's nutrition, physical growth, development, and healthcare and a measure of how MLH comply with tasks for PMTCT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who are or become mothers living in the catchment area at the time of recruitment
- •Women not identified as psychotic or delusional based on the interviewer's judgment
- •Women able to provide informed consent
排除标准
- •Inability to give informed consent
- •Inability to converse with the interviewer or the CHW
- •Miscarriage or stillbirth
- •Death of the infant
- •Death of the mother
结局指标
主要结局
Composite outcome: Number of significantly improved child and maternal outcomes
时间窗: 12 months
Out of 11 variables, we run 1000 simulations on the distribution of 0 and 1. The investigators total number of outcomes (each scored as 0=not present or 1=present) and determine if the Comprehensive CHW Cohort sum is significantly greater than expected based on the Control Cohort. For Mothers: 1. Breastfeeding 2. No alcohol in pregnancy 3. Not depressed 4. Adhere to medical regimens * For all mothers: -4 antenatal care visits * For HIV+ mothers: * Test for HIV * Take ARV * Give infant NVP and bactrim * infant PCR * exclusive breastfeeding For Children: 5. Not low birth weight 6. Growth in height 7. Growth in weight 8. Hospitalizations 9. Developmental milestones 10. Vaccinations 11. Child support grant Harwood JM, Weiss RE, Comulada WS. Beyond the Primary Endpoint Paradigm: A Test of Intervention Effect in HIV Behavioral Intervention Trials with Numerous Correlated Outcomes. Prevention Science. 2017 Jul 1;18(5):526-33.
次要结局
- Growth in weight-for-age (above -2SD)(Birth, 6 months, 12 months)
- Breastfeed for three months(6 months, 12 months)
- Breastfeed for six months(6 months, 12 months)
- Vaccinations up to date(12 months)
- Has Child Support Grant(12 months)
- Mothers test for HIV during pregnancy(Birth)
- Not depressed, EPDS below 13(Birth, 6 months, 12 months)
- WHO developmental scale measures at 50th percentile(12 months)
- Give infant NVP and Bactrim(6 months)
- No alcohol after learning that the participant was pregnant(Birth)
- Infant was not low birth weight(Birth)
- Attend 4 antenatal care visits(Birth)
- Growth in height-for-age (above -2SD)(Birth, 6 months, 12 months)
- Number of Hospitalizations(6 months, 12 months)
- PCR testing at 6 weeks(12 months)
- MLH take ARV during pregnancy(12 months)
- 6 months exclusive breastfeeding(6 months)