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Safety and Effectiveness of Triple Antiretroviral Drug Strategies for Prevention of Mother to Child HIV Transmission (R01)

Grant Amount: NICHD intends to commit $5,000,000 total costs to fund 5-10 awards in fiscal year 2014.

This funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) invites applications to evaluate the safety and effectiveness of implementation of triple antiretroviral drug strategies for prevention of mother to child HIV transmission in resource-constrained settings - either an approach in which antiretroviral drugs stop after breastfeeding cessation in women who don't require therapy for their own health (termed by the World Health Organization "Option B') or a strategy in which life-long antiretroviral therapy is started in all pregnant women regardless of immune or clinical status (sometimes referred to as "Option B+").

Applicants should propose novel methods for evaluating safety and effectiveness of implementing the strategy of use of triple ARV regimens for PMTCT (Option B/B+) in pregnant women in resource-constrained settings. 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 importantly 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.

Funding Organization
National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Fund Category
Support Types
Eligible Organizations
City Agencies
Commercial Organizations
Community Based Organizations
County Agencies
Educational Organizations/Institutions
Federal Government Agencies
International Agencies
IRS 501 (c)(3) Organizations
Nonprofit Organizations
Religious Organizations
State Agencies
Tribal Organizations
Number of Awards Given
5 to 10 awards
Award Amount Notes
NICHD intends to commit $5,000,000 total costs to fund 5-10 awards in fiscal year 2014.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.
Letter of Intent Date
Application Due Date
Project Start Date
Application Contact Customer Support
Phone: (800) 518-4726
Technical Contact
George Siberry
Phone: (301) 496-7350
Fund Duration
Up to 5 years.
Antiretroviral Drugs
HIV/AIDS Prevention
Perinatal Transmission
Research Programs
Application Process
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Web Site
Fund Number

Disclaimer: NPIN provides this information as a public service only. The views and information provided about the materials, funding opportunities, and organizations do not necessarily state or reflect those of the U.S. Department of Health and Human Services, CDC, or NPIN. Fund Record #4652

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