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PARTNERSHIPS FOR ENHANCED ENGAGEMENT IN RESEARCH (PEER) HEALTH
Cycle 1

Introducing "Option B+" in Malawi: Impact on Child Outcomes

Principal Investigator: Frank Chimbwandira, Ministry of Health, Malawi
NIH-Supported Collaborator: Matthias Egger, University of Bern
Title of NIH Award: International Epidemiologic Databases to Evaluate AIDS-Southern Africa (IeDEASA)

Project Overview
Background:
In September 2011, Malawi introduced the “Option B+” strategy to prevent mother-to-child transmission (PMTCT) of HIV and started all pregnant and breastfeeding women on lifelong antiretroviral therapy (ART), regardless of their clinical condition or CD4 cell count. Option B+ may improve PMTCT and may also reduce maternal morbidity and mortality (Hargrove et al., AIDS 2010) and transmission between serodiscordant partners (Cohen et al., 2011). Option B+ may also raise the rate of child survival by reducing HIV mother-tochild transmission and improving maternal health. However, concerns have been raised about the implementation of Option B+, acceptance of ART, and adherence and retention in care among Option B+ patients, who typically initiate ART in the early asymptomatic stage of an HIV infection (Coutsoudis, et al., Lancet 2013).

Objectives:
The goal of this project is to evaluate the Option B+ program in Malawi. In particular, the researchers plan on identifying challenges to program success by determining and describing the individual-, community- and health-system-level factors that limit or increase ART uptake, adherence and retention in care.We will analyze the effects of introducing Option B+ on HIV MTCT rates, HIV testing in infants, ART initiation in children, ART adherence, loss to follow-up and treatment changes among women who started ART with an Option B+ indication.Researchers will also examine the associations between PMTCT interventions mother and child outcomes such as HIV testing rates, MTCT rates, obstetric and newborn complications.

Methods:
The research design combines quantitative and qualitative methods. Using probabilistic record linkage, the team will link data on 1) pregnancy, 2) maternity, 3) follow-up visits of HIV exposed children, and, 4) medical records of HIV treatment sites and antiretroviral therapy use. The linkage will be based on personal identifiers and will for the first time allow a comprehensive national analysis of the whole continuum of care from pregnancy to ART start in children, in the context of the Option B+ program. The analysis will use data from 20 large facilities and all health care facilities (including small facilities with paper-based records) in a randomly selected district. The team will also conduct focus groups and qualitative interviews with Option B+ patients and health care providers and explore determinants of ART uptake, adherence and retention. Using this information the study team will develop a data collection tool to gather information on the identified barriers to care and use this tool to assess the standard of care at all included sites.

Public Health Impact:
This study will provide data on the outcomes under Option B+  and compare them with outcomes under Malawi’s previous PMTCT policy. Study results will also improve the effectiveness of Option B+ by suggesting ways the program may adapt to local conditions in Malawi.

NIH Collaborator:
Dr. Egger brings considerable expertise in record linkage and statistics to the project. An experienced team of researchers at the University of Bern, Switzerland, will also help in many aspects of the project.