An effectiveness study of an integrated, community-based package for maternal, newborn, child and HIV care in South Africa : study protocol for a randomized controlled trial
Date
2011-11
Authors
Tomlinson, Mark
Doherty, Tanya
Jackson, Debra
Lawn, Joy
Ijumba, Petrida
Colvin, Mark
Nkonki, Lungiswa
Daviaud, Emmanuelle
Goga, Ameena
Sanders, David
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central
Abstract
Background
Progress towards MDG4 in South Africa will depend largely on scaling up effective prevention against mother to child transmission (PMTCT) of HIV and also addressing neonatal mortality. This imperative drives increasing focus on the neonatal period and particularly on the development and testing of appropriate models of sustainable, community-based care in South Africa in order to reach the poor. A number of key implementation gaps affecting progress have been identified. Implementation gaps for HIV prevention in neonates; implementation gaps for neonatal care especially home postnatal care; and implementation gaps for maternal mental health support. We have developed and are evaluating and costing an integrated and scaleable home visit package delivered by community health workers targeting pregnant and postnatal women and their newborns to provide essential maternal/newborn care as well as interventions for Prevention of Mother to Child Transmission (PMTCT) of HIV.
Methods
The trial is a cluster randomized controlled trial that is being implemented in Umlazi which is a peri-urban settlement with a total population of 1 million close to Durban in KwaZulu Natal, South Africa. The trial consists of 30 randomized clusters (15 in each arm). A baseline survey established the homogeneity of clusters and neither stratification nor matching was performed. Sample size was based on increasing HIV-free survival from 74% to 84%, and calculated to be 120 pregnant women per cluster. Primary outcomes are higher levels of HIV free survival and levels of exclusive and appropriate infant feeding at 12 weeks postnatally. The intervention is home based with community health workers delivering two antenatal visits, a postnatal visit within 48 hours of birth, and a further four visits during the first two months of the infants life. We are undertaking programmatic and cost effectiveness analysis to cost the intervention.
Discussion
The question is not merely to develop an efficacious package but also to identify and test delivery strategies that enable scaling up, which requires effectiveness studies in a health systems context, adapting and testing Asian community-based studies in various African contexts.
Trial registration
ISRCTN: ISRCTN41046462
Description
The original publication is available at http://www.trialsjournal.com/content/12/1/236
Publication of this article was funded by the Stellenbosch University Open Access Fund.
Publication of this article was funded by the Stellenbosch University Open Access Fund.
Keywords
AIDS (Disease) in pregnancy -- Transmission -- Prevention -- South Africa, Neonatal care, Mother to child AIDS transmission -- Prevention, AIDS (Disease) -- Transmission, HIV infections -- Transmission, Child care -- South Africa
Citation
Tomlinson, M. et al. 2011. Trials. An effectiveness study of an integrated, community-based package for maternal, newborn, child and HIV care in South Africa : study protocol for a randomized controlled trial. Trials, 12(1):236, http://dx.doi.org/10.1186/1745-6215-12-236