HIV InfectionsNCT03517878
Evaluation of a Home-based Community Health Worker Program in Rural Eastern Cape, South Africa
An observational study of HIV Infections and HIV/AIDS, run by University of California, Los Angeles at 2 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV/AIDS, Depression
- What is being tested?
- Comprehensive CHW Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,490 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 11 Aug 2014to 1 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cohorts include all women meeting inclusion criteria from the catchment areas surrounding four clinics in the rural Eastern Cape.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Zithulele Hospital
Mqanduli, Eastern Cape, 5080
Stellenbosch University
Stellenbosch
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections, HIV/AIDS, Depression, Depressive Symptoms, Alcohol Use Disorder, Alcohol Drinking
- Being tested
- Comprehensive CHW Program
- Keywords
- Community Health Worker, Pregnancy, Breast Feeding, Child Development, Home Visits, Infants
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Depression, Alcoholism, Alcohol Drinking, Growth Disorders, Child Nutrition Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive CHW ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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:
- 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.
Measured: 12 months
Secondary outcomes (17)
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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: Birth
Not depressed, EPDS below 13
EPDS is asked after birth, 6 months after birth, and at 12 months after birth.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: 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.
Measured: 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.
Measured: 12 months
Has Child Support Grant
Mothers are asked "Does the child get a child support grant?"
Measured: 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?"
Measured: 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.
Measured: 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?"
Measured: 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?
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start11 Aug 2014
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- The ELMA Foundation, University of Stellenbosch, Philani Maternal Child Health and Nutrition Project
- Responsible party
- Sponsor
- Investigators
- Mark Tomlinson, PhD, Principal investigator, University of StellenboschKarl W le Roux, MB ChB, Principal investigator, Zithulele HospitalIngrid le Roux, MD, Principal investigator, Philani Maternal Child Health and Nutrition Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517878
- Sponsor's protocol ID
- N14/03/019
- Status last verified
- Oct 2018
- First submitted
- 14 Mar 2018
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Comparative Cohort Study Evaluating a Home-based Community Health Worker Program in the Rural Eastern Cape Province of South Africa
- ClinicalTrials.gov ID
- NCT03517878
- Acronym / sponsor ID
- N14/03/019
- Conditions
- HIV Infections, HIV/AIDS, Depression, Depressive Symptoms, Alcohol Use Disorder, Alcohol Drinking
- Keywords
- Community Health Worker, Pregnancy, Breast Feeding, Child Development, Home Visits, Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,490 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- The ELMA Foundation, University of Stellenbosch, Philani Maternal Child Health and Nutrition Project
- Study start
- 11 Aug 2014 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive CHW Cohort | – | Behavioral: Comprehensive CHW ProgramPregnant 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. |
| 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. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohorts include all women meeting inclusion criteria from the catchment areas surrounding four clinics in the rural Eastern Cape.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive CHW ProgramThe 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. | Behavioural | Comprehensive CHW Cohort |
Primary outcome
Composite outcome: Number of significantly improved child and maternal outcomes
Time frame: 12 months
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.
17 secondary outcomes
Breastfeed for three months
Time frame: 6 months, 12 months
Breastfeed for six months
Time frame: 6 months, 12 months
No alcohol after learning that the participant was pregnant
Time frame: Birth
Attend 4 antenatal care visits
Time frame: Birth
Not depressed, EPDS below 13
Time frame: Birth, 6 months, 12 months
Infant was not low birth weight
Time frame: Birth
Growth in height-for-age (above -2SD)
Time frame: Birth, 6 months, 12 months
Growth in weight-for-age (above -2SD)
Time frame: Birth, 6 months, 12 months
Number of Hospitalizations
Time frame: 6 months, 12 months
WHO developmental scale measures at 50th percentile
Time frame: 12 months
Vaccinations up to date
Time frame: 12 months
Has Child Support Grant
Time frame: 12 months
Mothers test for HIV during pregnancy
Time frame: Birth
MLH take ARV during pregnancy
Time frame: 12 months
Give infant NVP and Bactrim
Time frame: 6 months
PCR testing at 6 weeks
Time frame: 12 months
6 months exclusive breastfeeding
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Philani WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Tomlinson, PhD principal investigator
University of Stellenbosch
Karl W le Roux, MB ChB principal investigator
Zithulele Hospital
Ingrid le Roux, MD principal investigator
Philani Maternal Child Health and Nutrition Project
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV/AIDS, run by University of California, Los Angeles at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome: Number of significantly improved child and maternal outcomes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.