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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)
Dates: May 2013 - April 2018

Project Overview

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-to-child 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). 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. 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. 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.

PH 1-5 Malawi photo1PH 1-5 Malawi photo2
Research team members working from paper medical records.  
A team member works on the digitization of paper medical records using a camera - a necessary step to perform probabilistic record linkage.

Summary of Recent Activities:

Dr. Chimbwandira reports that his team’s manuscript entitled “HIV transmission and retention in care among HIV-exposed children enrolled in Malawi’s prevention of mother-to-child transmission programme” was published in the September 2017 issue of the Journal of the International AIDS Society ( The researchers are also responding to reviewer comments on two other recent manuscripts on HIV-infected women and children in Malawi. In addition, they have recently recruited a new data manager/statistician to bolster the team after the resignation of the study coordinator. The new staff member is working to develop a concept sheet on “Association of ARV exposure and stillbirth pre- and post-Option B+ among HIV infected women.”

As the project moves towards its close at the end of April 2018, the PI and his group will continue with data analyses and development of at least three manuscripts. Although they have received a small grant from another source that will cover their operating expenses through the end of 2018, they are also working to secure more substantial new funding. They have had informal contact with representatives from CDC Malawi, the World Health Organization, and the Global Fund in Geneva, and they plan to have formal meetings in early 2018 to present their project in greater detail.

Health Cycle 1 Recipients