# Novel Methods to Inform HIV/TB Clinical Trial Development

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2024 · $809,775

## Abstract

During the first 3.5 years of this R37 cycle, Novel Methods to Inform HIV/TB Clinical Trial Development
 has used decision science methodologies, focusing on value of information, and demonstrated
 outstanding productivity, methods expansion, trainee development, policy impact, and international
 collaboration. As we complete this cycle and look forward to the subsequent one, we will continue to
 develop and utilize novel VOI methods, applying them to ongoing and new international trial activities with
 the following specific aims:
1) To calculate the expected value of sample information (ESVI) using generalized additive models
(GAMs) within the Monte Carlo simulation of the Cost-effectiveness of Preventing AIDS Complications
(CEPAC) model.
2) To expand upon the methods developed in Aim 1 to inform new clinical trial design, post-trial
evaluation, and priority setting in the areas of HIV and TB in South Africa, focusing on newly reported and
potential high-impact trials. We will focus on three areas:
i. Antiretroviral Treatment Strategies
ii. Vaccines and Antibody-Mediated Prevention
iii. Novel Tuberculosis Diagnostic, Treatment, and Vaccination Strategies
We anticipate continued major productivity in the next R37 cycle, informing decision makers on efficient
use of resources both in the implementation of trial results once already performed and in the conduct of
those being designed.
RELEVANCE (See instructions):
 HIV and TB remain high among the top ten causes of death in low-income countries. Given the budgetary
 constraints to conduct the array of ongoing and potential clinical trials, we have developed a Value of
 Information (VOI) framework to assess a priori which trials might provide the best value, formally
 comparing courses of action with and without new information – as might be obtained from a trial – to
 quantify the value of information acquisition, accounting for both the trial benefits and costs.

## Key facts

- **NIH application ID:** 10894794
- **Project number:** 5R01AI093269-14
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Krishna P Reddy
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $809,775
- **Award type:** 5
- **Project period:** 2011-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10894794

## Citation

> US National Institutes of Health, RePORTER application 10894794, Novel Methods to Inform HIV/TB Clinical Trial Development (5R01AI093269-14). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10894794. Licensed CC0.

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