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R01HD111355

Project Grant

Overview

Grant Description
Adolescent-Tailored HIV Treatment and Prevention Strategies in South Africa: Projecting Clinical Benefits and Value - Project Abstract

Globally, HIV-related deaths have decreased 60% from their peak in 2004. Adolescents and young adults (AYA) ages 10 to 24, however, comprise the only age group that has not seen improvements in HIV-related mortality since then. Adolescent is a distinct developmental period, in which risk-taking and impulsive decision-making are normative behaviors. Stigma, disclosure concerns, and medication toxicity impact HIV health behaviors at a time when AYA may also experience their first sexual relationships.

Differences in HIV health outcomes by age are partly due to late diagnosis, as well as to challenges in accessing treatment and prevention modalities requiring daily adherence. This problem is particularly acute in South Africa, which has the largest HIV epidemic in the world, with one in three new infections there occurring among AYA.

Recent advances in long-acting HIV prevention and treatment formulations that avert the need to take a daily pill hold major promise, particularly for AYA. With support to Dr. Neilan from an NICHD K08 HD094638 (2018-2023) as well as from the Adolescent Medicine for HIV/AIDS Interventions Trials Network U24HD089880 (2017-2022), we developed the Cost-Effectiveness of Preventing AIDS Complications-Adolescent and Young Adult (CEPAC-AYA) microsimulation model.

We have conducted 12 model-based clinical and cost-effectiveness analyses addressing key questions in AYA HIV prevention, diagnosis, and treatment in the United States. In a new US-South Africa collaboration, we now propose to adapt and expand the structure of this simulation model and assemble necessary data inputs, and then to use the model to identify the most effective and cost-effective approaches and monitoring strategies for the treatment and prevention of HIV among AYA in South Africa.

We have three specific aims:

AIM 1. Develop new structure within the CEPAC-AYA model and derive data to permit modeling of long-acting ART and PrEP regimens for AYA in South Africa.

AIM 2. Evaluate the clinical impact, cost, and cost-effectiveness of new AYA-focused treatment interventions to decrease opportunistic infections and mortality among AYA in South Africa.

AIM 3. Assess the clinical impact, cost, and cost-effectiveness of new AYA-focused prevention interventions to reduce HIV incidence among AYA in South Africa.

The goal of this proposal is to evaluate context-specific, adolescent-tailored care strategies and to identify the best use of limited resources to improve health outcomes for AYA affected by HIV in South Africa. As new treatments and delivery systems emerge, the model will be poised to inform how to best deploy these resources for this vulnerable population.
Funding Goals
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.
Place of Performance
Boston, Massachusetts 021142509 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 354% from $830,757 to $3,770,170.
The General Hospital Corporation was awarded Adolescent-Tailored HIV Treatment Strategies in South Africa Project Grant R01HD111355 worth $3,770,170 from the National Institute of Child Health and Human Development in September 2022 with work to be completed primarily in Boston Massachusetts United States. The grant has a duration of 5 years and was awarded through assistance program 93.865 Child Health and Human Development Extramural Research. The Project Grant was awarded through grant opportunity NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed).

Status
(Ongoing)

Last Modified 8/20/25

Period of Performance
9/20/22
Start Date
8/31/27
End Date
59.0% Complete

Funding Split
$3.8M
Federal Obligation
$0.0
Non-Federal Obligation
$3.8M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01HD111355

Transaction History

Modifications to R01HD111355

Additional Detail

Award ID FAIN
R01HD111355
SAI Number
R01HD111355-2778161192
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Nonprofit With 501(c)(3) IRS Status (Other Than An Institution Of Higher Education)
Awarding Office
75NT00 NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development
Funding Office
75NT00 NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development
Awardee UEI
FLJ7DQKLL226
Awardee CAGE
0ULU5
Performance District
MA-08
Senators
Edward Markey
Elizabeth Warren

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Institute of Child Health and Human Development, National Institutes of Health, Health and Human Services (075-0844) Health research and training Grants, subsidies, and contributions (41.0) $1,623,597 100%
Modified: 8/20/25