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

NCT03517878 | Completed

• 1 other identifier: N14/03/019
• Study Type: observational
• Target: 1,490
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Community Health Worker; Pregnancy; Breast Feeding; Child Development; Home Visits; Infants

Outcome Measures

Primary Outcomes (1)

• 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: 1. Breastfeeding 2. No alcohol in pregnancy 3. Not depressed 4. Adhere to medical regimens * For all mothers: -4 antenatal care visits * For HIV+ mothers: * Test for HIV * Take ARV * Give infant NVP and bactrim * infant PCR * exclusive breastfeeding For Children: 5. Not low birth weight 6. Growth in height 7. Growth in weight 8. Hospitalizations 9. Developmental milestones 10. Vaccinations 11. 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 Outcomes (17)

• Breastfeed for three months

  6 months, 12 months

• Breastfeed for six months

  6 months, 12 months

• No alcohol after learning that the participant was pregnant

  Birth

• Attend 4 antenatal care visits

  Birth

• Not depressed, EPDS below 13

  Birth, 6 months, 12 months

Study Arms (2)

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

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.

Interventions

Comprehensive CHW Program 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.

Comprehensive CHW Cohort

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• The ELMA Foundation: collaborator
• University of Stellenbosch: collaborator
• Philani Maternal Child Health and Nutrition Project: collaborator

Study Sites (2)

Zithulele Hospital

Mqanduli, Eastern Cape, 5080, South Africa

Location

Stellenbosch University

Stellenbosch, South Africa

Location

Related Links

• Philani Website

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Depression; Alcoholism; Alcohol Drinking; Growth Disorders; Child Nutrition Disorders; Breast Feeding

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior

Study Officials

• Mark Tomlinson, PhD

  University of Stellenbosch

  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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: May 8, 2018
• Study Start: August 11, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 22, 2025

Record last verified: 2018-10

Locations

ZA (2)