Clinical trial NCT02957799: Improving South African Government Workers' Capacities to Deliver HIV Interventions
Official title: A Randomized Controlled Trial to Improve the South African Government's Community Health Workers' Capacities to Deliver Evidence-based Interventions for Optimizing HIV Outcomes and Reducing Its Comorbidities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: HIV
Partner Violence
Malnutrition
Alcohol Use/Abuse
Depression
Keywords: Pregnancy
Home Healthcare Visits
Community Health Workers
Infants
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Stellenbosch
First posted: 2016-11-08
Enrollment: 840
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of significantly improved child and maternal outcomes
timeFrame: 2 Years
Secondary outcomes:
measure: Number of significantly improved child and maternal outcomes for HIV positive mothers
timeFrame: 2 Years
Other outcomes:
Locations:
city: Stellenbosch
country: South Africa
facility: Stellenbosch University
city: Zithulele
country: South Africa
facility: Zithulele Hospital
Study officials:
affiliation: Study Principal Investigator Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
name: Mary Jane Rotheram-Borus
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.