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Randomized Controlled Trial
. 2017 Aug 7;18(1):368.
doi: 10.1186/s13063-017-2074-5.

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

Mary Jane Rotheram-Borus  1 , Karl Le Roux  2 , Ingrid M Le Roux  3 , Joan Christodoulou  4 , Christina Laurenzi  5 , Nokwanele Mbewu  3 , Mark Tomlinson  5
Affiliations
Randomized Controlled Trial

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

Mary Jane Rotheram-Borus et al. Trials. .

Abstract

Background: Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in research evaluations, efficacy disappears when programs are scaled broadly. In this cluster randomized controlled trial (RCT), we examine whether the benefits of ongoing accountability and supervision within an existing government funded and implemented community health workers (CHW) home visiting program ensure the effectiveness of home visiting.

Methods/design: In the deeply rural, Eastern Cape of South Africa, CHW will be hired by the government and will be initially trained by the Philani Programme to conduct home visits with all pregnant mothers and their children until the children are 2 years old. Eight clinics will be randomized to receive either (1) the Accountable Care Condition in which additional monitoring and accountability systems that Philani routinely uses are implemented (4 clinics, 16 CHW, 450 households); or (2) a Standard Care Condition of initial Philani training, but with supervision and monitoring being delivered by local government structures and systems (4 clinics, 21 CHW, 450 households). In the Accountable Care Condition areas, the CHW's mobile phone reports, which are time-location stamped, will be monitored and data-informed supervision will be provided, as well as monitoring growth, medical adherence, mental health, and alcohol use outcomes. Interviewers will independently assess outcomes at pregnancy at 3, 6, 15, and 24 months post-birth. The primary outcome will be a composite score of documenting maternal HIV/TB testing, linkage to care, treatment adherence and retention, as well as child physical growth, cognitive functioning, and child behavior and developmental milestones.

Discussion: The proposed cluster RCT will evaluate whether routinely implementing supervision and accountability procedures and monitoring CHWs' over time will improve MCH outcomes over the first 2 years of life.

Trial registration: ClinicalTrials.gov registration #NCT02957799 , registered on October 26, 2016.

Keywords: HIV; Infants; Maternal health; Mothers; Perinatal health; Pregnancy; South Africa.

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Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the Institutional Review Boards (IRB#16-001362) of the University of California, Los Angeles and Stellenbosch University (#N16/05/064). All mothers will be asked to provide voluntary informed consent to participate in the study at recruitment. Eight pairs of well-matched health clinics serving at least 24 neighborhoods in Zithulele will be involved; Stellenbosch University serves as the centralized ethical review committee for Zithulele Hospital and all surrounding clinics.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrollment, interventions, and assessments
Fig. 2
Fig. 2
Description of the RCT for area randomization by UCLA to one of two conditions
See this image and copyright information in PMC

References

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