Viewing Study NCT02957799



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Last Modification Date: 2024-10-26 @ 12:13 PM
Study NCT ID: NCT02957799
Status: UNKNOWN
Last Update Posted: 2021-10-14
First Post: 2016-10-26

Brief Title: Improving South African Government Workers Capacities to Deliver HIV Interventions
Sponsor: University of California Los Angeles
Organization: University of California Los Angeles

Study Overview

Official Title: A Randomized Controlled Trial to Improve the South African Governments Community Health Workers Capacities to Deliver Evidence-based Interventions for Optimizing HIV Outcomes and Reducing Its Comorbidities
Status: UNKNOWN
Status Verified Date: 2021-10
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to address the United States Office of AIDS Research highest priorities improving the workforce reducing health disparities and addressing HIV comorbidities UCLA will randomize the government-funded community health workers CHW from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either 1 the Accountable Condition AC in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2 a Control Condition CC of initial Philani training but ongoing supervision and monitoring consistent with local government practices
Detailed Description: Each dollar invested in maternal child health MCH yields a nine-fold benefit Home visiting has been repeatedly demonstrated efficacious in improving MCH outcomes including when delivered by CHW in low and middle income countries LMIC However when home visiting programs are scaled they are not effective Africa has particular challenges with broad implementation of effective interventions often associated with the poorly trained and poorly monitored health personnel in this case CHW who are perinatal home visitors

The investigators have shown that with training supervision and accountability CHW home visits are effective in a successful randomized controlled trial RCT 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 challenges concurrently The visits significantly improved maternal and child outcomes over three years Based on these results the Philani Intervention Model served as one model for re-engineering primary health care for 65000 CHW in South Africa The Mthatha Provincial Government has agreed for the Philani Program to train monitor and supervise their already-hired CHW This RCT will evaluate whether routinely implementing training and monitoring CHW behavior and MCH outcomes with mobile phones and providing data-informed supervision will result in CHW becoming more effective 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 15 months and 24 months later The primary outcome will be maternal HIVTB testing linkage to care treatment adherence and retention in medical regimens depression and parenting and her childs physical growth cognitive functioning and behavior adjustment

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01MH111391 NIH None httpsreporternihgovquickSearchR01MH111391