Improving South African Government Workers' Capacities to Deliver HIV Interventions

NCT ID: NCT02957799

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 840 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2023-10-31

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.

Conditions

HIV; Partner Violence; Malnutrition; Alcohol Use/Abuse; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Accountable Condition- 8 clinics

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.

Group Type: EXPERIMENTAL

Accountable Condition

Intervention Type: BEHAVIORAL

Mothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive ongoing monitoring and supervision. CHW will monitor mother's health and linkage to care; CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. CHW will also have a mobile phone to record information at each visit. CHW will log their home visits each day, rate the content and skills addressed on the mobile phone, weigh children, and report outcome achievements (e.g., receiving the child grant, immunizations, breastfeeding, and retention/ adherence to HIV care). The CHW in this arm will receive data-informed supervision. CHW will be monitored weekly with review of contact logs, recorded outcomes, and random site visits by supervising in-service training on a monthly basis. The Accountable Condition will last for two years (until the child is 24 months old).

Control Condition- 8 clinics

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.

Group Type: EXPERIMENTAL

Control Condition

Intervention Type: BEHAVIORAL

Mothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive supervision and monitoring consistent with local government practices. CHW will monitor mother's health and linkage to care. CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. The Control Condition will last for two years (until the child is 24 months old).

Interventions

Accountable Condition

Mothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive ongoing monitoring and supervision. CHW will monitor mother's health and linkage to care; CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. CHW will also have a mobile phone to record information at each visit. CHW will log their home visits each day, rate the content and skills addressed on the mobile phone, weigh children, and report outcome achievements (e.g., receiving the child grant, immunizations, breastfeeding, and retention/ adherence to HIV care). The CHW in this arm will receive data-informed supervision. CHW will be monitored weekly with review of contact logs, recorded outcomes, and random site visits by supervising in-service training on a monthly basis. The Accountable Condition will last for two years (until the child is 24 months old).

Intervention Type: BEHAVIORAL

Control Condition

Mothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive supervision and monitoring consistent with local government practices. CHW will monitor mother's health and linkage to care. CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. The Control Condition will last for two years (until the child is 24 months old).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Stellenbosch

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Mary Jane Rotheram-Borus

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Jane Rotheram-Borus

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA

Locations

Stellenbosch University

Stellenbosch, , South Africa

Zithulele Hospital

Zithulele, , South Africa

Countries

South Africa

References

Minozzi S, Ambrosi L, Saulle R, Uhm SS, Terplan M, Sinclair JM, Agabio R. Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD015042. doi: 10.1002/14651858.CD015042.pub2.

Reference Type: DERIVED

PMID: 38682758 (View on PubMed)

Rotheram-Borus MJ, le Roux KW, Norwood P, Stansert Katzen L, Snyman A, le Roux I, Dippenaar E, Tomlinson M. The effect of supervision on community health workers' effectiveness with households in rural South Africa: A cluster randomized controlled trial. PLoS Med. 2023 Mar 2;20(3):e1004170. doi: 10.1371/journal.pmed.1004170. eCollection 2023 Mar.

Reference Type: DERIVED

PMID: 36862754 (View on PubMed)

Rotheram-Borus MJ, Le Roux K, Le Roux IM, Christodoulou J, Laurenzi C, Mbewu N, Tomlinson M. To evaluate if increased supervision and support of South African Government health workers' home visits improves maternal and child outcomes: study protocol for a randomized control trial. Trials. 2017 Aug 7;18(1):368. doi: 10.1186/s13063-017-2074-5.

Reference Type: DERIVED

PMID: 28784142 (View on PubMed)

Other Identifiers

R01MH111391

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH111391

Identifier Type: NIH

Identifier Source: org_study_id

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