Improving South African Government Workers' Capacities to Deliver HIV Interventions

Phase 2

• Conditions: HIV; Partner Violence; Malnutrition; Alcohol Use/Abuse; Depression
• Interventions: Behavioral: Control Condition; Behavioral: Accountable Condition

• Registration Number: NCT02957799
• Lead Sponsor: University of California, Los Angeles

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 65,000 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 HIV/TB testing, linkage to care, treatment adherence and retention in medical regimens, depression, and parenting; and her child's physical growth, cognitive functioning, and behavior adjustment.

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-08
• Study Start: 2017-06-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-14
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 840

Inclusion Criteria

• Mothers living in the catchment area
• Mothers not identified as psychotic or delusional based on the interviewer's judgment
• Mothers able to provide informed consent

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Exclusion Criteria

• Inability to give informed consent
• Inability to converse with the interviewer or the CHW
• Death of the mother or infant.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Condition- 8 clinics	Control Condition	The Control Condition will include mothers who receive home visits from government-funded CHW who will be trained once under Philani and receive supervision and monitoring consistent with local government practices.
Accountable Condition- 8 clinics	Accountable Condition	In the Accountable Condition, the intervention includes mothers who will receive home visits from government-funded CHW who will be trained once under Philani and receive ongoing monitoring and supervision.

Primary Outcome Measures

Name	Time	Method
Number of significantly improved child and maternal outcomes	2 Years	Out of 10 variables, the investigators total number of outcomes that are significantly better in the Accountable Condition compared to the Control Condition. The variables are for mothers and children: For Mothers: 1. Adhere to medical regimens; 2. Breastfeed for six months (mixed ok); 3. No alcohol after learning that the participant was pregnant; 4. Mental health, EPDS; For Children: 5. Growth in height (\<-2SD); 6. Growth in weight (\<-2SD); 7. Number of Hospitalizations; 8. WHO developmental scale measure in normal range; 9. In normal range of CBCL; 10. In normal range on the Bayley

Secondary Outcome Measures

Name	Time	Method
Number of significantly improved child and maternal outcomes for HIV positive mothers	2 Years	Out of 9 variables, the investigators total the number of outcomes that are significantly better in the Accountable Condition compared to the Control Condition for HIV positive mothers. The variables are: 1. ARV 6 weeks before birth; 2. NVP at birth; 3. Cipro for child; 4. TB testing; 5. AZT for child; 6. PCR testing at 6 weeks; 7. Get the results of PCR testing; 8. One feeding method for 6 months; 9. Breastfeed solely for 6 months.

Trial Locations

Locations (2)

Stellenbosch University; 🇿🇦 Stellenbosch, South Africa

Zithulele Hospital; 🇿🇦 Zithulele, South Africa