Evaluation of a Home-based Community Health Worker Program in Rural Eastern Cape, South Africa
NCT03517878 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1490
Last updated 2025-12-22
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.
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
Interventions
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
The ELMA Foundation
collaborator OTHER -
University of Stellenbosch
collaborator OTHER -
Philani Maternal Child Health and Nutrition Project
collaborator UNKNOWN -
University of California, Los Angeles
lead OTHER
Principal Investigators
-
Mark Tomlinson, PhD · University of Stellenbosch
-
Karl W le Roux, MB ChB · Zithulele Hospital
-
Ingrid le Roux, MD · Philani Maternal Child Health and Nutrition Project
Eligibility
- Min Age
- 0 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-08-11
- Primary Completion
- 2018-06-01
- Completion
- 2018-06-01
Countries
- South Africa
Study Locations
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