Abstract
BackgroundDespite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. In 2012, there were 94,000 HIV-positive pregnant women in Mozambique. Approximately 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended “Option B+” strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Given the limited experience with Option B+ in sub-Saharan Africa, few rigorous pragmatic trials have studied this new treatment strategy.MethodsThis study utilizes an initial formative research process involving patient and health care provider interviews and focus groups, workforce assessments, value stream mapping, and commodity utilization assessments to understand the strengths and weaknesses in the current Option B+ care cascade. The formative research is intended to guide identification and prioritization of key workflow modifications and the development of an enhanced adherence and retention package. These two components are bundled into a defined intervention implemented and evaluated across six health facilities utilizing a stepped wedge randomized controlled trial study design. The overall objective of this trial is to develop and test a pilot intervention in central Mozambique to implement the new Option B+ guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) who start ART prior to delivery and are retained in care.DiscussionThis pragmatic study utilizes research strategies that have the potential to meaningfully improve the Option B+ care cascade in central Mozambique and to decrease the MTCT of HIV. This trial is designed to identify critical low-cost improvement strategies that can be bundled into a defined intervention. If this intervention has a measurable impact, it can be rapidly scaled up to other ANC in Mozambique and sub-Saharan Africa.Trial registrationClinicalTrials.gov: NCT02371265.
Highlights
Despite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of Human immunodeficiency virus (HIV) remains a significant problem globally, especially in sub-Saharan Africa
In resourcepoor settings where caesarean delivery is rarely available or safe, initial prevention of MTCT (PMTCT) efforts focused on reducing MTCT using ARV therapy during labor and delivery, promotion of exclusive breastfeeding for 6 months, and complete breastfeeding cessation [7,8,9,10]
Goals and objectives The overall objective of this study is to develop and test a pilot intervention in central Mozambique to implement the new World Health Organization (WHO) guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) clinics who start anti-retroviral therapy (ART) prior to delivery and improve retention in acre after 90 days
Summary
Despite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended “Option B+” strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Short courses of anti-retroviral (ARV) drugs started early in pregnancy or during labor can reduce the risk of in utero and peripartum HIV transmission two- to threefold [5]. PMTCT includes testing and counseling, family planning counseling, provision of an appropriate antiretroviral regimen for women and newborns, and support for safer infant feeding
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