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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517878 on ClinicalTrials.gov