title: Goodstart: a cluster randomised effectiveness trial of an integrated, community-based package for maternal and newborn care, with prevention of mother-to-child transmission of HIV in a South African township.
abstract: BACKGROUND
  Progress towards MDG4 for child survival in South Africa requires effective prevention of mother-to-child transmission (PMTCT) of HIV including increasing exclusive breastfeeding, as well as a new focus on reducing neonatal deaths. This necessitates increased focus on the pregnancy and early post-natal periods, developing and scaling up appropriate models of community-based care, especially to reach the peri-urban poor.
  
  
  METHODS
  We used a randomised controlled trial with 30 clusters (15 in each arm) to evaluate an integrated, scalable package providing two pregnancy visits and five post-natal home visits delivered by community health workers in Umlazi, Durban, South Africa. Primary outcomes were exclusive and appropriate infant feeding at 12 weeks post-natally and HIV-free infant survival.
  
  
  RESULTS
  At 12 weeks of infant age, the intervention was effective in almost doubling the rate of exclusive breastfeeding (risk ratio 1.92; 95% CI: 1.59-2.33) and increasing infant weight and length-for-age z-scores (weight difference 0.09; 95% CI: 0.00-0.18, length difference 0.11; 95% CI: 0.03-0.19). No difference was seen between study arms in HIV-free survival. Women in the intervention arm were also more likely to take their infant to the clinic within the first week of life (risk ratio 1.10; 95% CI: 1.04-1.18).
  
  
  CONCLUSIONS
  The trial coincided with national scale up of ARVs for PMTCT, and this could have diluted the effect of the intervention on HIV-free survival. We have demonstrated that implementation of a pro-poor integrated PMTCT and maternal, neonatal and child health home visiting model is feasible and effective. This trial could inform national primary healthcare reengineering strategies in favour of home visits. The dose effect on exclusive breastfeeding is notable as improving exclusive breastfeeding has been resistant to change in other studies targeting urban poor families.
authors.affiliation: Department of Psychology, Stellenbosch University, Stellenbosch, South Africa.
authors.forename: Mark
authors.initials: M
authors.lastname: Tomlinson
authors.affiliation: Health Systems Research Unit, Medical Research Council, Tygerberg, South Africa.|School of Public Health, University of the Western Cape, Bellville, South Africa.
authors.forename: Tanya
authors.initials: T
authors.lastname: Doherty
authors.affiliation: Health Systems Research Unit, Medical Research Council, Tygerberg, South Africa.|International Maternal and Child Health, Uppsala University, Uppsala, Sweden.
authors.forename: Petrida
authors.initials: P
authors.lastname: Ijumba
authors.affiliation: Health Systems Research Unit, Medical Research Council, Tygerberg, South Africa.|School of Public Health, University of the Western Cape, Bellville, South Africa.
authors.forename: Debra
authors.initials: D
authors.lastname: Jackson
authors.affiliation: Saving Newborn Lives, Save the Children, Cape Town, South Africa.
authors.forename: Joy
authors.initials: J
authors.lastname: Lawn
authors.affiliation: International Maternal and Child Health, Uppsala University, Uppsala, Sweden.
authors.forename: Lars Åke
authors.initials: LÅ
authors.lastname: Persson
authors.affiliation: Biostatistics Unit, Medical Research Council, Tygerberg, South Africa.
authors.forename: Carl
authors.initials: C
authors.lastname: Lombard
authors.affiliation: School of Public Health, University of the Western Cape, Bellville, South Africa.
authors.forename: David
authors.initials: D
authors.lastname: Sanders
authors.affiliation: Health Systems Research Unit, Medical Research Council, Tygerberg, South Africa.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Daviaud
authors.affiliation: Health Systems Research Unit, Medical Research Council, Tygerberg, South Africa.
authors.forename: Lungiswa
authors.initials: L
authors.lastname: Nkonki
authors.affiliation: Health Systems Research Unit, Medical Research Council, Tygerberg, South Africa.
authors.forename: Ameena
authors.initials: A
authors.lastname: Goga
authors.affiliation: Health Systems Research Unit, Medical Research Council, Tygerberg, South Africa.
authors.forename: Sarah
authors.initials: S
authors.lastname: Rohde
authors.affiliation: International Maternal and Child Health, Uppsala University, Uppsala, Sweden.
authors.forename: Deborah
authors.initials: D
authors.lastname: Sitrin
authors.affiliation: Deceased. Formerly Maromi Health Research, Glenwood, South Africa.
authors.forename: Mark
authors.initials: M
authors.lastname: Colvin
authors.affiliation: School of Public Health, University of the Western Cape, Bellville, South Africa.|UNICEF, New York, NY, USA.
authors.forename: Mickey
authors.initials: M
authors.lastname: Chopra
mesh_terms: D000293:Adolescent; D000328:Adult; D001942:Breast Feeding / Q000706:statistics & numerical data*; D002675:Child, Preschool; D016000:Cluster Analysis; D003153:Community Health Services; D003150:Community Health Workers; D019052:Depression, Postpartum / Q000453:epidemiology; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission; D007722:Health Knowledge, Attitudes, Practice; D006792:House Calls; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D016014:Linear Models; D008427:Maternal Health Services / Q000379:methods*; D017063:Outcome Assessment, Health Care; D011203:Poverty; D011247:Pregnancy; D015397:Program Evaluation; D013019:South Africa / Q000453:epidemiology; D015996:Survival Rate; D014505:Urban Population / Q000706:statistics & numerical data; D055815:Young Adult
keywords: HIV; South Africa; community health worker; community‐based; integrated; newborn; post‐natal care; prevent mother‐to‐child transmission (PMTCT); primary health care