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

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dc.contributor.authorTomlinson, Mark
dc.contributor.authorDoherty, Tanya
dc.contributor.authorJackson, Debra
dc.contributor.authorLawn, Joy
dc.contributor.authorIjumba, Petrida
dc.contributor.authorColvin, Mark
dc.contributor.authorNkonki, Lungiswa
dc.contributor.authorDaviaud, Emmanuelle
dc.contributor.authorGoga, Ameena
dc.contributor.authorSanders, David
dc.contributor.authorLombard, Carl
dc.contributor.authorPersson, Lars-Ake
dc.contributor.authorNdaba, Thoko
dc.contributor.authorSnetro, Gail
dc.contributor.authorChopra, Mickey
dc.date.accessioned2012-01-24T13:56:32Z
dc.date.available2012-01-24T13:56:32Z
dc.date.issued2011-11
dc.date.updated2011-12-30T16:04:35Z
dc.descriptionThe original publication is available at http://www.trialsjournal.com/content/12/1/236en_ZA
dc.descriptionPublication of this article was funded by the Stellenbosch University Open Access Fund.
dc.description.abstractBackground 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: ISRCTN41046462en_ZA
dc.description.versionPublishers' versionen_ZA
dc.format.extent9 p.
dc.identifier.citationTomlinson, 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/10.1186/1745-6215-12-236en_ZA
dc.identifier.issn1745-6215
dc.identifier.urihttp://dx.doi.org/10.1186/1745-6215-12-236
dc.identifier.urihttp://hdl.handle.net/10019.1/19377
dc.language.isoen_ZAen_ZA
dc.language.rfc3066en
dc.publisherBioMed Centralen_ZA
dc.rights.holderTomlinson et al.; licensee BioMed Central Ltd.en_ZA
dc.subjectAIDS (Disease) in pregnancy -- Transmission -- Prevention -- South Africaen_ZA
dc.subjectNeonatal careen_ZA
dc.subjectMother to child AIDS transmission -- Preventionen_ZA
dc.subjectAIDS (Disease) -- Transmissionen_ZA
dc.subjectHIV infections -- Transmissionen_ZA
dc.subjectChild care -- South Africaen_ZA
dc.titleAn effectiveness study of an integrated, community-based package for maternal, newborn, child and HIV care in South Africa : study protocol for a randomized controlled trialen_ZA
dc.typeArticleen_ZA
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