The first findings from a study in the Kingdom of Swaziland on a new approach to reduce mother to child transmission of HIV were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI 2016) in Boston.
Led by ICAP at Columbia University's Mailman School of Public Health, and conducted in partnership with the Swaziland Ministry of Health, and the University of Cape Town, Safe Generations is an implementation science study supported by the U.S. President's Emergency Plan For AIDS Relief through the United States Agency for International Development (USAID) to evaluate the impact, feasibility, and cost-effectiveness of Option B+, a simplified approach to prevent mother to child transmission (PMTCT) of HIV. Swaziland has a generalized HIV epidemic, and one in three pregnant women is HIV-infected.
Option B+ calls for lifelong antiretroviral therapy (ART) for all HIV-positive pregnant and breastfeeding women, regardless of CD4+ cell count. By comparison, previous approaches to PMTCT offered ART only to women with evidence of advanced HIV infection. Option B+ has been adopted across most of sub-Saharan Africa; however, there are limited data on its impact on the health outcomes of women and their infants.
From September 2013 to June 2014, ICAP conducted a stepped-wedge trial including 2,315 HIV-positive pregnant women at 12 health facilities in Swaziland. One health facility transitioned routine PMTCT care from Option A to Option B+ each month, and the study compared Option A and Option B+ in terms of the proportion of women initiating ART and retention in care. It looked at a variety of other outcomes, including HIV transmission rates to the infant, client and health worker acceptability, and cost effectiveness. The antiretroviral Atripla was provided by Gilead and Merck pharmaceuticals for use in this study.
Initial findings from Safe Generations show that implementation of Option B+ greatly increased the number of women initiating ART and dramatically improved ART coverage among pregnant women. Unfortunately, researchers found that retention in care, particularly postpartum, was very low and no better under Option B+ than previous PMTCT approaches.
"It was exciting to learn that Option B+ offers substantial advantages over other approaches to PMTCT," said Elaine Abrams, MD, principal investigator of the study and senior research director at ICAP. "But we learned that, in Swaziland, it doesn't address all of the challenges women face obtaining health services during pregnancy and the postpartum period," she added. "Other interventions are urgently needed to improve retention in care and optimize health outcomes for women and their babies."
With only 25 percent of eligible women initiating ART during pregnancy, the Government of Swaziland embraced the potential of Option B+ to simplify antenatal ART services and increase women's uptake of treatment. Local evidence was needed, however, to determine if this streamlined approach would lead to more effective PMTCT.
"Safe Generations is the first study of its kind in Swaziland, reflecting the on-the-ground experience of PMTCT service delivery. The study provides insight into how health services are delivered and how changes in HIV care impact maternal child health outcomes," said USAID Assistant Administrator Ariel Pablos-Méndez.
Through an implementation science approach, the study helped build in-country capacity for national roll-out of Option B+. Its findings will inform programs and policies not only in Swaziland, but in many countries in sub-Saharan Africa and other settings around the world where preventing mother to child HIV transmission remains a critical challenge.
"The Safe Generations study is a unique and wonderful scientific partnership," Dr. Abrams said. "USAID's support, through contributions from the American people, enabled ICAP to work hand-in-hand with the Swaziland Ministry of Health to improve the health of HIV-positive mothers and their children, helping contribute to the global goal of eliminating new pediatric infections and keeping mothers alive."