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Randomized Controlled Trial
. 2013 Jun 1;27(9):1461-71.
doi: 10.1097/QAD.0b013e3283601b53.

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

Affiliations
Randomized Controlled Trial

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

Ingrid M le Roux et al. AIDS. .

Abstract

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 PIP's effect on 28 measures of maternal and infant well being among WLH and among all mothers using random effects regression models. For each group, PIP's 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.

Trial registration: ClinicalTrials.gov NCT00996528.

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Conflict of interest statement

Competing Interests, Financial Disclosure, and Licensing

No authors have any competing interests. All authors have completed the Authorship Responsibility, Financial Disclosure, and Copyright Transfer form and declare no conflicts of interest: no support from any organisation for the submitted work, no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work.

The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

The Corresponding Author has the right to grant on behalf of all authors and does grant on behalf of all authors, a worldwide licence to the Publishers and its licensees in perpetuity, in all forms, formats and media (whether known now or created in the future), to i) publish, reproduce, distribute, display and store the Contribution, ii) translate the Contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or abstracts of the Contribution, iii) create any other derivative work(s) based on the Contribution, iv) to exploit all subsidiary rights in the Contribution, v) the inclusion of electronic links from the Contribution to third party material where-ever it may be located; and, vi) licence any third party to do any or all of the above.

Figures

Figure 1
Figure 1
Movement of participants through the trial at each assessment point for mothers in the Standard Care (SC) and the Philani Intervention Program (PIP).
Figure 2
Figure 2
Adherence to cumulative behaviours in the PMTCT cascade among women living with HIV (WLH, N=354), by intervention condition: Philani Intervention Program (PIP, N=185) vs. Standard Care (SC, N=169). Key: A. Maternal AZT prior to labour, or full ARVs B. Maternal AZT during labour, or full ARVs C. Maternal NVP at onset of labour, or full ARVs D. Infant NVP within 24 hours of birth E. Infant AZT dispensed and medicating as prescribed F. Infant HIV PCR test and results G. One feeding method first 6 months Note: "+" indicates that the behaviour listed includes itself and all behaviours listed to the left: cumulative adherence. *Estimated OR, PIP vs. SC (95% CI): 1.95 (1.36, 2.79); p<0.001. From random effects logistic regression, adjusted for neighbourhood clustering, controlling for baseline employment.

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