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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)

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:

As of March 2017, the research team has used the data that they have collected and entered into an electronic database to perform several analyses. One research question examined adherence of women on antiretroviral therapy (ART) receiving care at the 20 study facilities with electronic data. Useing objective pharmacy-based adherence measures and validating adherence measures against virologic outcomes, the team found that adherence to ART was poor during pregnancy, but improved after delivery. Longer-term adherence of most Option B+ patients is adequate, but around a third of all women remain at adherence levels of <90%. This finding raised the need for adherence interventions during the first six months on ART. The study was presented at the International Workshop on HIV Observational Databases in Budapest 2016 (oral presentation) and at the International AIDS Conference in Durban (poster presentation). A manuscript has been published in the journal CID. A paper on outcomes of HIV-exposed children aimed at estimating cumulative incidence of vertical HIV transmission, taking loss to follow-up into account was submitted for publication and is under review. The data suggested that loss to follow-up was highest among children who enrolled late, who did not receive post-exposure prophylaxis, and/or whose mothers were not on antiretroviral therapy during pregnancy. An additional paper is being drafted, aimed at describing the procedures employed in the project from data processing and linkage of datasets generated. Together with other local organizations the team co-hosted a national meeting on PMTCT. All major stakeholders in the field of PMTCT in the country participated and findings from the PEER project were presented.

The Malawi Ministry of Health (MoH), siuppored by Dignitas International, has established an innovative Knowledge Translation Platform (KTPMalawi) to translate policy relevant research into practice (see KTPMalawi establishes Communities of Practice (COPs) which engage policymakers, researchers, and implementers to produce policy-relevant documents, such as policy and implementation briefs. The team initiated the establishment of a prevention of mother-to-child transmission (PMTCT) COP. As a result, the team lobbied policy makers, researchers and implementers to include a PMTCT COP during the national KTPMalawi priority setting meeting. The COP was later established after the research team’s analysis on low retention in the Option B+ program was published and presented to national stakeholders. Additionally, the PEER team was chosen to lead a team of 7 authors for the PMTCT policy brief. The team has developed a draft policy brief which proposes strategies that can address the problem of suboptimal retention in care for Option B+ women. In addition to leading the writing of the policy brief, we also co-financed some of the writing sessions.

Health Cycle 1 Recipients