Evaluation of a Home-based Community Health Worker Program in Rural Eastern Cape, South Africa
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| ClinicalTrials.gov Identifier: NCT03517878 |
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Recruitment Status :
Completed
First Posted : May 8, 2018
Last Update Posted : October 11, 2018
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Sponsor:
University of California, Los Angeles
Collaborators:
The ELMA Foundation
University of Stellenbosch
Philani Maternal Child Health and Nutrition Project
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles
| Tracking Information | ||||||||||
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| First Submitted Date | March 14, 2018 | |||||||||
| First Posted Date | May 8, 2018 | |||||||||
| Last Update Posted Date | October 11, 2018 | |||||||||
| Actual Study Start Date | August 11, 2014 | |||||||||
| Actual Primary Completion Date | June 1, 2018 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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:
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT03517878 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Evaluation of a Home-based Community Health Worker Program in Rural Eastern Cape, South Africa | |||||||||
| 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 | |||||||||
| 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. | |||||||||
| 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. |
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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| 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. | |||||||||
| Condition |
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| Intervention | 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.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
1490 | |||||||||
| Original Estimated Enrollment |
1300 | |||||||||
| Actual Study Completion Date | June 1, 2018 | |||||||||
| Actual Primary Completion Date | June 1, 2018 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | South Africa | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03517878 | |||||||||
| Other Study ID Numbers | N14/03/019 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Mary Jane Rotheram-Borus, University of California, Los Angeles | |||||||||
| Study Sponsor | University of California, Los Angeles | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | University of California, Los Angeles | |||||||||
| Verification Date | October 2018 | |||||||||