Outcomes of home visits for pregnant mothers and their infants: a cluster randomized controlled trial.

OBJECTIVE: To evaluate the effect of home visits by community health workers (CHWs) on maternal and infant well being from pregnancy through the first 6 months of life for women living with HIV (WLH) and all neighborhood mothers. DESIGN AND METHODS: In a cluster randomized controlled trial in Cape Town townships neighborhoods were randomized within matched pairs to either standard care comprehensive healthcare at clinics (n=12 neighborhoods; n=169 WLH; n=594 total mothers); or Philani Intervention Program home visits by CHWs in addition to standard care (PIP; n=12 neighborhoods; n=185 WLH; n=644 total mothers). Participants were assessed during pregnancy (2% refusal) and reassessed at 1 week (92%) and 6 months (88%) postbirth. We analyzed PIPs effect on 28 measures of maternal and infant well being among WLH and among all mothers using random effects regression models. For each group PIPs overall effectiveness was evaluated using a binomial test for correlated outcomes. RESULTS: Significant overall benefits were found in PIP compared to standard care among WLH and among all participants. Secondarily compared to standard care PIP WLH were more likely to complete tasks to prevent vertical transmission use one feeding method for 6 months avoid birth-related medical complications and have infants with healthy height-for-age measurements. Among all mothers compared to standard care PIP mothers were more likely to use condoms consistently breastfeed exclusively for 6 months and have infants with healthy height-for-age measurements. CONCLUSION: PIP is a model for countries facing significant reductions in HIV funding whose families face multiple health risks.