A request for applications with set aside is proposed, entitled “Safety and Effectiveness of Triple Antiretroviral Strategies for Prevention of Mother to Child HIV Transmission” using the R01 Research Project grant mechanism.
Purpose
The purpose of this RFA is to stimulate investigator-initiated research in a neglected area of great public health importance: the safety and effectiveness of combination antiretroviral (ARV) drugs used for prevention of mother to child transmission of HIV in resource constrained settings.
Scope
Applicants should propose novel methods for evaluating the safety and effectiveness of implementing the use of triple ARV regimens for prevention of perinatal transmission of HIV in resource-constrained settings, including the Option B strategy of time-limited ARV during pregnancy and breastfeeding and the Option B+ strategy of initiation of lifelong ARV regimens when HIV infection is identified in pregnancy. Areas of interest include, but are not limited to:- Systems for surveillance of adverse pregnancy outcomes including preterm birth, stillbirth, and congenital anomalies among women receiving ARV with appropriate unexposed control groups; of particular interest are cohorts of women who conceive while receiving ART that is then continued throughout pregnancy.
- Studies to evaluate the acceptability of and adherence to triple ARV regimens given to HIV-infected women for PMTCT, particularly in women not yet candidates for ART for their own health.
- Optimal service organization and models to deliver ART and monitor its efficacy in maternal/child health and primary care settings.
- Models to maximize retention in care and adherence to antiretrovirals during pregnancy, breastfeeding, and beyond.
- Systems for surveillance for HIV resistance among women initiating on long-term ARV and among infants who become infected despite maternal ART.
- Studies to evaluate the effectiveness of Option B/B+ on MTCT rates, both early, 6 week and overall rates at the end of breastfeeding, and on HIV-free survival.
- Studies to evaluate the hypothesized effectiveness and benefit of Option B/B+ on maternal health and prevention of sexual transmission among discordant partners.
- Studies to evaluate the costs and cost-benefit of Option B/B+.
- Studies to evaluate the impact of Option B/B+ on the ability of the country program to serve all adults in need of treatment.
Objective
The goal of this RFA is to provide data on the feasibility, effectiveness, safety, and sustainability of scaling up interventions to prevent perinatal HIV transmission and maintain maternal and child health in resource-constrained settings. The initiative will look at real world implementation of Option B and Option B+, effectiveness of linking pregnant women to care, adherence to treatment and care, and long-term maintenance of viral control as well as the safety of the approach for the women and infants.Program Contact
Lynne M. Mofenson MD
Maternal and Pediatric Infectious Disease Branch
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