NIH grant: Novel Methods to Inform HIV/TB Clinical Trial Development (1R01AI200758-01)

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NIH grant 1R01AI200758-01: Novel Methods to Inform HIV/TB Clinical Trial Development
Institute: {'code': 'AI', 'abbreviation': 'NIAID', 'name': 'National Institute of Allergy and Infectious Diseases', 'admin_org_id': '12500003', 'admin_funding_url': ''}. PI: Krishna P Reddy. Award: $830944.
Start: 2026-07-17T00:00:00.
PROJECT SUMMARY
Clinical trials provide the gold standard of evidence for guiding the care of people with HIV and tuberculosis
(TB), but they require years to complete and substantial commitments of time, money, personnel, and
participants. Given resource limitations, difficult decisions must be made by funders and trialists about which
trials to pursue. Value-of-information (VOI) analysis is a formal approach to setting research priorities. This
application, from investigators who have been leaders in applying modeling methods to HIV and TB clinical
policy questions, will expand VOI analytic methods within a microsimulation model of HIV and TB to address
emerging issues in clinical trial design. First, we will advance methods for estimating the VOI of new clinical
trials, accounting for alternative priorities and different implementation, eligibility, and subgroup criteria.
Second, we will apply these and other methods to inform HIV/TB clinical trial design and priority-setting. We
will assess the value of trials that focus on populations not included in prior trials, as well as the value of trials
of emerging TB vaccines and long-acting medications for people with HIV. This research will address high
priority goals of the NIH Office of AIDS Research, including cross-cutting research in HIV and comorbid TB that
aims to maximize the information obtained from limited trial budgets. This research will also address NIH
priorities for health economics research, including modeling the impact of interventions on health outcomes
and healthcare utilization. Through methodological advances and applications to key HIV/TB questions, this
research will help decision makers choose the best possible use of limited resources to ultimately improve the
care and outcomes of people with HIV and TB.

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