Improving South African Government Workers' Capacities to Deliver HIV Interventions

NCT02957799 | Unknown Phase 2 DMC

• 1 other identifier: R01MH111391
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Pregnancy; Home Healthcare Visits; Community Health Workers; Infants

Outcome Measures

Primary Outcomes (1)

• Number of significantly improved child and maternal outcomes

  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

  2 Years

Secondary Outcomes (1)

• Number of significantly improved child and maternal outcomes for HIV positive mothers

  2 Years

Study Arms (2)

Accountable Condition- 8 clinics

EXPERIMENTAL

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.

Behavioral: Accountable Condition

Control Condition- 8 clinics

EXPERIMENTAL

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.

Behavioral: Control Condition

Interventions

Accountable Condition 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).

Accountable Condition- 8 clinics

Control Condition 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).

Control Condition- 8 clinics

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Stellenbosch: collaborator

Study Sites (2)

Stellenbosch University

Stellenbosch, South Africa

Location

Zithulele Hospital

Zithulele, South Africa

Location

Related Publications (3)

• 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.

  PMID: 38682758 DERIVED

• 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.

  PMID: 36862754 DERIVED

• 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.

  PMID: 28784142 DERIVED

MeSH Terms

Conditions

Malnutrition; Depression

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Mary Jane Rotheram-Borus

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 8, 2016
• Study Start: June 1, 2017
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

ZA (2)