Clinical trial NCT03517878: Evaluation of a Home-based Community Health Worker Program in Rural Eastern Cape, South Africa
Official title: A Non-randomized Comparative Cohort Study Evaluating a Home-based Community Health Worker Program in the Rural Eastern Cape Province of South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
HIV/AIDS
Depression
Depressive Symptoms
Alcohol Use Disorder
Alcohol Drinking
Stunting
Alcohol; Harmful Use
Child Development
Child Malnutrition
Child Nutrition Disorders
Birth Weight Less Than 10Th Percentile
Keywords: Community Health Worker
Pregnancy
Breast Feeding
Child Development
Home Visits
Infants
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: The ELMA Foundation
name: University of Stellenbosch
name: Philani Maternal Child Health and Nutrition Project
First posted: 2018-05-08
Enrollment: 1490
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohorts include all women meeting inclusion criteria from the catchment areas surrounding four clinics in the rural Eastern Cape.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Composite outcome: Number of significantly improved child and maternal outcomes
timeFrame: 12 months
Secondary outcomes:
measure: Breastfeed for three months
timeFrame: 6 months, 12 months
measure: Breastfeed for six months
timeFrame: 6 months, 12 months
measure: No alcohol after learning that the participant was pregnant
timeFrame: Birth
measure: Attend 4 antenatal care visits
timeFrame: Birth
measure: Not depressed, EPDS below 13
timeFrame: Birth, 6 months, 12 months
measure: Infant was not low birth weight
timeFrame: Birth
measure: Growth in height-for-age (above -2SD)
timeFrame: Birth, 6 months, 12 months
measure: Growth in weight-for-age (above -2SD)
timeFrame: Birth, 6 months, 12 months
measure: Number of Hospitalizations
timeFrame: 6 months, 12 months
measure: WHO developmental scale measures at 50th percentile
timeFrame: 12 months
measure: Vaccinations up to date
timeFrame: 12 months
measure: Has Child Support Grant
timeFrame: 12 months
measure: Mothers test for HIV during pregnancy
timeFrame: Birth
measure: MLH take ARV during pregnancy
timeFrame: 12 months
measure: Give infant NVP and Bactrim
timeFrame: 6 months
measure: PCR testing at 6 weeks
timeFrame: 12 months
measure: 6 months exclusive breastfeeding
timeFrame: 6 months
Other outcomes:
Locations:
city: Mqanduli
country: South Africa
facility: Zithulele Hospital
state: Eastern Cape
city: Stellenbosch
country: South Africa
facility: Stellenbosch University
Study officials:
affiliation: University of Stellenbosch
name: Mark Tomlinson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zithulele Hospital
name: Karl W le Roux, MB ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Philani Maternal Child Health and Nutrition Project
name: Ingrid le Roux, MD
role: PRINCIPAL_INVESTIGATOR
References: