P01HD107670

Closing Research Gaps in Antiretroviral Treatment for Pregnant Women and Infants Living with HIV - Overall Project Summary/Abstract

Antiretroviral treatment (ART) options for pregnant women and children living with HIV have fallen behind those for adults, reflecting the substantial research gap for modern ART regimens in these groups. Safety and efficacy studies of specific ART regimens in pregnancy, and strategies for starting modern ART in early infancy, have become research priorities.

Here we propose a series of interrelated projects that expand the scientific objectives and data utilization of a valuable NIH-funded nationwide birth surveillance system in Botswana (the TSEPAMO study), and connect it with the infrastructure provided by an existing program for identifying and treating infants with HIV (the Early Infant Treatment study, or EIT).

The four proposed projects, anchored by administrative and data cores, include:

1) TSEPAMO Plus: Expanded Congenital Abnormalities Surveillance and an Emulated Clinical Trial to Evaluate Weight Impact on Birth Outcomes for Newer ART Regimens: An expanded surveillance program for neural tube defects and other congenital abnormalities following exposure to modern ART regimens, and an emulated clinical trial to address critical questions related to the use of ART regimens by maternal weight strata.

2) Methodology: Developing Reporting Criteria for Pregnancy Surveillance Cohorts and New Techniques for Supporting Target Trials: The creation of surveillance reporting criteria in pregnancy cohorts and validation of a target trial approach to ART regimen comparisons.

3) Point-of-Care HIV Testing and Early Dolutegravir Use for Infants: A new approach to targeted facility-based point-of-care HIV testing, combined with an optimized ART management strategy that uses dolutegravir from early infancy.

4) Pioneering Precision Medicine Approaches for Immune Control of Pediatric HIV-1 Infection: Utilizing shared data and infrastructure to efficiently obtain specimens, this project will bank HIV sequences from early-treated infants, measure and compare viral reservoir and chromosomal positioning between ART regimens, and study immune responses to mRNA vaccines among children with HIV to begin development of an mRNA HIV vaccine program for children in Botswana.

This P01 brings together a group of experienced investigators who will forge a cohesive research program using the unique data sources and outstanding physical infrastructure available from the TSEPAMO and EIT research programs in Botswana. Each project addresses key scientific issues related to ART use during pregnancy and initiation of ART in early infancy, and together they will efficiently close research gaps for women and children with HIV.

President And Fellows Of Harvard College

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Boston, Massachusetts 021156028 United States

Single Zip Code

NICHD Program Project Grants for HIV Research (P01 Clinical Trial Optional) (RFA-HD-21-023)

Amendment Since initial award the total obligations have increased 358% from $1,340,804 to $6,146,740.