Request for Information (RFI): Interest in data and specimens from the Hemophilia Growth and Development Study (HGDS) for research on HIV-associated comorbidities, coinfections and complications

Notice Number: NOT-HL-19-747

Key Dates
Release Date: January 21, 2020
Response Date: March 23, 2020

Related Announcements

Issued by
National Heart, Lung, and Blood Institute (NHLBI)


This Notice is a time-sensitive Request for Information (RFI) inviting comments on potential interest in data and specimens from the Hemophilia Growth and Development Study (HGDS) repository for research on HIV-associated comorbidities, coinfections and complications, especially in heart, lung, blood and sleep (HLBS), as well as suggestions or ideas on how investigators may want to use the data and specimens from the cohort for what kind of research.


The Hemophilia Growth and Development Study (HGDS) was funded by the NIH to examine the longitudinal effects of hemophilia on child and adolescent health and development. HGDS was established by 14 US hemophilia treatment centers in 1988 and data were prospectively collected through 1996/97. The cohort consisted of 380 children and adolescents (all males), 6 to 19 years old with hemophilia (n=333), with or without HIV infection but at risk of HIV infection, and a subset of their unaffected male siblings (n=47). The cohort included 59 Hispanics and 321 Non-Hispanics, 41 Blacks or African Americans, 333 Whites and 6 with Unknown races. Further information is available through this link: DASH Data and Specimen Hub (

The HGDS investigated the effects of hemophilia and HIV on physical growth and maturation; immunological, neurological, and neuropsychological functioning; and the pathophysiology of HIV and hepatitis C. Research using the clinical data and stored samples continued and included the genetic research that paved the way for development of the protease inhibitors currently used to treat HIV; studies that provided clues to viral characteristics of HIV and hepatitis B and C; research to identify genetic factors associated with the development of inhibitory antibodies to factor VIII; the relationship of inhibitors to cognitive development and academic achievement; studies of viral factors and how they relate to progression of HIV and hepatitis C; and research on the parenteral transmission of human viruses.

A total of 41,068 samples from the study are still available: 8,019 cell samples in 1.8 ml aliquots (including many immortalized B-cell lines), 14,102 serum samples in 0.5 mL aliquots, and 18,947 plasma samples in 0.5 aliquots. The samples are accompanied by phenotypic and genotypic data as shown in the DASH Data and Specimen Hub (

HGDS is unique in several aspects: 1) It was the largest early cohort of children and adolescents with hemophilia with or without HIV infection but at risk of HIV infection (n=333); 2) Given that the population was postnatally infected with HIV, such a cohort will not be encountered in the future, at least in the developed world, given the availability of safe clotting factor concentrates; persons with hemophilia and HIV may differ from those who are perinatally infected with HIV in that they may have a more protracted course of disease, they usually lack risk factors commonly associated with perinatal infections, such as HIV infection in a parent or lower socio-economic status (confounding variables), and they may experience a different developmental course compared to perinatally HIV-infected individuals with hemophilia because of differences in rate of brain growth depending on age at which infection occurred.

Recently, NHLBI published two NOSIs to invite applications to study HIV-associated heart, lung, blood and sleep comorbidities: Notice of Special Interest: SEARCH: Stimulating ExplorAtory Research on HIV/AIDS Contribution to Heart, Lung, Blood and Sleep Comorbidities (R01 - Clinical Trial Not Allowed) (NOT-HL-19-677) and Notice of Special Interest (NOSI): Leveraging existing HIV observational cohorts to study HIV-associated HLBS disorders (NOT-HL-19-705). The HIV program at NHLBI could facilitate access to the HGDS data and specimen repository if investigators should be interested in having such access to conduct research on HIV-associated comorbidities, coinfections and complications among persons with hemophilia, provided that the proposed research is appropriately reviewed and determined to be of scientific merit and that privacy of participants is protected, with no individual DNA sequencing data published or released.

Information Requested

This RFI seeks input from stakeholders throughout the scientific research community and the general public. Individuals wishing to provide feedback may respond to any number of the following topics:

  • Interest in using the data and specimens from the HGDS cohort for future research on HIV-associated comorbidities, coinfections and complications.
  • Scientific questions that could be answered with this collection.
  • Kind(s) of research that could be conducted by using the data and specimens from the HGDS cohort.
  • How the research study or studies could be carried out, with only the existing data and specimens from HGDS or also with data and specimens from other cohorts.
  • New methods that could be developed using this collection.
  • Unique value of data and specimens from the HGDS cohort or from a component of the collection.

How to Submit a Response

All responses to this RFI must be submitted electronically to the following webpage at by March 23, 2020. The suggested response length is up to 1000 words.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

We look forward to your input and hope that you will share this RFI document with your colleagues.


Please direct all inquiries to:

Shimian Zou, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8301