Notice Number: NOT-AI-16-076

Key Dates
Release Date: August 9, 2016
Response Date: September 23, 2016

Issued by
National Institutes of Allergy and Infectious Diseases (NIAID)

Purpose

The Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Disease is soliciting responses for information regarding the availability, content and suitability of pre-existing clinical trial and population datasets for constructing synthetic populations that would enable investigators to examine HIV transmission dynamics and estimate the impact of prevention interventions and strategies.

NIAID DAIDS is interested in compiling information on available data sets and their potential suitability for examination of HIV transmission dynamics as a means to estimate the impact of HIV prevention interventions and the randomized clinical trials (RCTs). Data sets capturing US and international epidemics and sub-epidemics are of interest, especially those that include broadly representative populations, adolescents, young women, transgender people and men who have sex with men (MSM).
The information obtained will be used to evaluate whether NIAID DAIDS should consider developing processes for using simulation science with synthetic clinical cohorts as one of the methods for prioritization of future prevention trials. Comments are invited from any interested parties.

Background

An increasing number of HIV interventions and strategies have recently been shown to have various degrees of protective efficacy. Which of intervention and strategies should be tested in RCTS and/or implemented and in what combinations for specific populations and settings are critical questions for the prevention field. RCTs are needed to answer these questions for both the US and international epidemics and sub-epidemics require large sample sizes and major funding. Simulation science offers a strategy for down-selecting prevention interventions and optimizing those that go into RCTs. However, an obstacle to implementing modeling of synthetic clinical cohorts is identifying the clinical and population databases needed to develop the synthetic cohorts required to simulate potential outcomes and impact. Understanding the suitability of existing datasets to support a modeling/simulation science approach for identifying the RCTs with the highest potential impact on the AIDS pandemic is critical to achieving desired reductions in AIDS incidence.

Information Requested

NIAID DAIDS is seeking input to inform on the data sets and populations they represent that are available to examine HIV transmission dynamics as a tool to estimate the potential impact of HIV prevention interventions using clinical trial simulation methods.

Areas of possible comment include but are not limited to:
1. Data sets and populations they represent that are available to examine HIV transmission dynamics
2. Evaluative statements on the types of data contained in the data sets, and whether it meets the minimal standards needed to support clinical trial simulation.
3. Web-links to a study or associated data-base, if available.
4. Evaluative assessments/statements on the suitability of the data type such as evaluative comments on key parameters the data set contains or lacks such as frequency of data points and data format.
4. Response may include data format (indicating all that are workable and those preferred), coding, and other technical details to the degree it is felt to be helpful for facilitating the use of the data set(s).
5. Specific approaches to data structure, harmonization, and any other recommendations for making it easier for investigators to use these databases to achieve the objectives stated above.

How to Submit a Response

Responses to this RFI can be submitted via email to the Division of AIDS at: [email protected] using the subject "HIV datasets". Responses will be accepted until September 23, 2016.

Responses to this RFI are voluntary. This RFI is for planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health or NIAID. The NIAID does not intend to make any type of award based on responses to the RFI or to pay for either the preparation of information submitted or the Government's use of such information.

The NIAID will use the information submitted in response to the RFI at its discretion. Respondents are advised that the Government is under no obligation to acknowledge receipt of information provided and will not provide feedback to respondents. The NIH and the government reserve the right to use any non-proprietary technical information in any future solicitation(s).

Inquiries

Please direct all inquiries to:

David Burns, M.D.
National Institute of Allergy and Infectious Diseases
Telephone: 301-435-8896
Email: [email protected]