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Evaluation of a Home-based Community Health Worker Program in Rural Eastern Cape, South Africa

NCT ID: NCT03517878

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-11

Study Completion Date

2018-06-01

Brief Summary

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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

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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.

Conditions

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Alcohol; Harmful Use Child Development Child Malnutrition Child Nutrition Disorders Birth Weight Less Than 10Th Percentile Depression Depressive Symptoms Alcohol Use Disorder Alcohol Drinking Stunting HIV Infections HIV/AIDS

Keywords

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Community Health Worker Pregnancy Breast Feeding Child Development Home Visits Infants

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Comprehensive CHW Cohort

Pregnant women who become mothers and their infants living in areas served by the comprehensive CHW program. These are areas around two primary health care clinics and matched to the Control Cohort clinic areas.

Comprehensive CHW Program

Intervention Type BEHAVIORAL

The comprehensive CHW Cohort will receive home visits from CHWs recruited, trained, and supervised by the Philani organization. Philani has a 30-year history of non-stigmatizing home-based support for women and children in Cape Town. The organization has been operating their comprehensive CHW program in the rural Eastern Cape since 2010; however, in the research areas, CHWs have only been active for one year prior to initiation of the study. Philani recruits CHWs that are "positive peer deviants" to serve as role models in the community. The CHWs then receive training, materials, and skills to address major community health challenges of HIV, TB, malnutrition, alcohol use, and depression. The CHWs also receive ongoing monitoring and supervision as well as support for difficult cases.

Control Cohort

Pregnant women who become mothers and their infants living in areas that are not served by the comprehensive CHW program. These are areas around two primary health care clinics and matched to the Comprehensive CHW Cohort clinic areas.

No interventions assigned to this group

Interventions

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Comprehensive CHW Program

The comprehensive CHW Cohort will receive home visits from CHWs recruited, trained, and supervised by the Philani organization. Philani has a 30-year history of non-stigmatizing home-based support for women and children in Cape Town. The organization has been operating their comprehensive CHW program in the rural Eastern Cape since 2010; however, in the research areas, CHWs have only been active for one year prior to initiation of the study. Philani recruits CHWs that are "positive peer deviants" to serve as role models in the community. The CHWs then receive training, materials, and skills to address major community health challenges of HIV, TB, malnutrition, alcohol use, and depression. The CHWs also receive ongoing monitoring and supervision as well as support for difficult cases.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The ELMA Foundation

OTHER

Sponsor Role collaborator

University of Stellenbosch

OTHER

Sponsor Role collaborator

Philani Maternal Child Health and Nutrition Project

UNKNOWN

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Tomlinson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Stellenbosch

Karl W le Roux, MB ChB

Role: PRINCIPAL_INVESTIGATOR

Zithulele Hospital

Ingrid le Roux, MD

Role: PRINCIPAL_INVESTIGATOR

Philani Maternal Child Health and Nutrition Project

Locations

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Zithulele Hospital

Mqanduli, Eastern Cape, South Africa

Site Status

Stellenbosch University

Stellenbosch, , South Africa

Site Status

Countries

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South Africa

Related Links

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http://www.philani.org.za/

Philani Website

Other Identifiers

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N14/03/019

Identifier Type: -

Identifier Source: org_study_id