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

A Non-randomized Comparative Cohort Study Evaluating a Home-based Community Health Worker Program in the Rural Eastern Cape Province of South Africa

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.

Study Overview

• Status: Completed
• Conditions: Depression; HIV Infections; Alcohol Drinking; Alcohol; Harmful Use; HIV/AIDS; Depressive Symptoms; Child Development; Alcohol Use Disorder; Stunting; Child Nutrition Disorders; Child Malnutrition; Birth Weight Less Than 10Th Percentile
• Intervention / Treatment: Behavioral: Comprehensive CHW Program

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.

• Study Type: Observational
• Enrollment (Actual): 1490

Contacts and Locations

Study Locations

• South Africa
  • Stellenbosch, South Africa
    • Stellenbosch University
  • Eastern Cape
    • Mqanduli, Eastern Cape, South Africa, 5080
      • Zithulele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome: Number of significantly improved child and maternal outcomes	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: Breastfeeding; No alcohol in pregnancy; Not depressed; Adhere to medical regimensFor all mothers:-4 antenatal care visitsFor HIV+ mothers:Test for HIVTake ARVGive infant NVP and bactriminfant PCRexclusive breastfeedingFor Children:; Not low birth weight; Growth in height; Growth in weight; Hospitalizations; Developmental milestones; Vaccinations; 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeed for three months	Mothers are asked at the 6 month and 12 month follow up "How long after your baby's birth did you stop breastfeeding your baby completely?"	6 months, 12 months
Breastfeed for six months	Mothers are asked at the 6 month and 12 month follow up "How long after your baby's birth did you stop breastfeeding your baby completely?"	6 months, 12 months
No alcohol after learning that the participant was pregnant	At the birth interview mothers are asked "Have you ever used alcohol during this pregnancy?" and follows up with "Did you continue to drink alcohol after you knew you were pregnant?"	Birth
Attend 4 antenatal care visits	At the birth interview antenatal care cards are inspected and mothers are asked "How many antenatal care visits did you attend?"	Birth
Not depressed, EPDS below 13	EPDS is asked after birth, 6 months after birth, and at 12 months after birth.	Birth, 6 months, 12 months
Infant was not low birth weight	Birth weight is recorded from child's road to health card and baby is weighed by data collector shortly after birth (this value is used when road to health card is not available).	Birth
Growth in height-for-age (above -2SD)	Child height/length is recorded shortly after birth, at 6 months, and at 12 months. Values are compared to WHO norms and turned into a Z score.	Birth, 6 months, 12 months
Growth in weight-for-age (above -2SD)	Child weight is recorded shortly after birth, at 6 months, and at 12 months. Values are compared to WHO norms and turned into a Z score.	Birth, 6 months, 12 months
Number of Hospitalizations	At 6 months and 12 months after birth mothers are asked "During the past 3 months, have you taken the child to the hospital for any reason?" and "How many times have you taken the child to the hospital?"	6 months, 12 months
WHO developmental scale measures at 50th percentile	WHO measures of child development are used and children are compared to the mean level of achievement for their age. Fussy or sleepy children may be unable to be evaluated.	12 months
Vaccinations up to date	Data collectors examine the child's road to health card to determine if all immunizations are up to date and which ones are missing. A photo is taken of this page for confirmation.	12 months
Has Child Support Grant	Mothers are asked "Does the child get a child support grant?"	12 months
Mothers test for HIV during pregnancy	Data collectors look for any evidence on the antenatal card of an HIV test during pregnancy. If not, or if card is unavailable, check with the mother if she has previously tested positive for HIV or ask "Did you have a test for HIV during this pregnancy?"	Birth
MLH take ARV during pregnancy	Mothers are asked "When did you start taking ARVs?" and antenatal cards and health cards are examined for evidence of ARV prescription and start date.	12 months
Give infant NVP and Bactrim	Mothers are asked "Did you get Nevarapine syrup for your baby around the time of birth?"; "Are you currently using nevirapine syrup for the baby?" and "Are you currently still giving your child bactrim?"	6 months
PCR testing at 6 weeks	Mothers are asked "Has you child been tested for HIV yet?" and "Do you know what the result of your child's HIV test (PCR) is?" Data collectors independently confirm this information on the child's road to health card to determine how many times (if at all) the child has been tested for HIV?	12 months
6 months exclusive breastfeeding	Mothers are asked "How soon after birth did you give your child something else in addition to breastmilk?" In addition, mothers are asked to provide a 24 hour, 1 months, and 3 month dietary recall.	6 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: University of Stellenbosch; The ELMA Foundation; Philani Maternal Child Health and Nutrition Project
• Investigators: Principal Investigator: Karl W le Roux, MB ChB, Zithulele Hospital; Principal Investigator: Ingrid le Roux, MD, Philani Maternal Child Health and Nutrition Project; Principal Investigator: Mark Tomlinson, PhD, University of Stellenbosch

Publications and helpful links

Helpful Links

• Philani Website

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2014
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Child Development; Pregnancy; Breast Feeding; Infants; Community Health Worker; Home Visits
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Mental Disorders; Pathologic Processes; Nutrition Disorders; Immune System Diseases; Behavioral Symptoms; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Slow Virus Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Feeding Behavior; HIV Infections; Alcoholism; Alcohol Drinking; Depression; Acquired Immunodeficiency Syndrome; Child Nutrition Disorders; Growth Disorders; Breast Feeding
• Other Study ID Numbers: N14/03/019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No