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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Method to Extend Research in Time (MERIT) Award (R37)
Project #
4R37AI093269-10
Application #
9890410
Study Section
Special Emphasis Panel (NSS)
Program Officer
Gezmu, Misrak
Project Start
2011-09-01
Project End
2025-08-31
Budget Start
2020-09-01
Budget End
2021-08-31
Support Year
10
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Massachusetts General Hospital
Department
Type
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code
02114
O'Laughlin, Kelli N; He, Wei; Greenwald, Kelsy E et al. (2018) Feasibility and acceptability of home-based HIV testing among refugees: a pilot study in Nakivale refugee settlement in southwestern Uganda. BMC Infect Dis 18:332
Luz, Paula M; Osher, Benjamin; Grinsztejn, Beatriz et al. (2018) The cost-effectiveness of HIV pre-exposure prophylaxis in men who have sex with men and transgender women at high risk of HIV infection in Brazil. J Int AIDS Soc 21:e25096
Neilan, Anne M; Cohn, Jennifer E; Lemaire, Jean-Francois et al. (2018) HIV Testing After a First Positive Rapid Diagnostic Test: A Role for Nucleic Acid Testing? Open Forum Infect Dis 5:ofy170
Freedberg, Kenneth A; Kumarasamy, Nagalingeswaran; Borre, Ethan D et al. (2018) Clinical Benefits and Cost-Effectiveness of Laboratory Monitoring Strategies to Guide Antiretroviral Treatment Switching in India. AIDS Res Hum Retroviruses 34:486-497
Ciaranello, Andrea; Sohn, Annette H; Collins, Intira Jeannie et al. (2018) Simulation Modeling and Metamodeling to Inform National and International HIV Policies for Children and Adolescents. J Acquir Immune Defic Syndr 78 Suppl 1:S49-S57
Mallampati, Divya; MacLean, Rachel L; Shapiro, Roger et al. (2018) Optimal breastfeeding durations for HIV-exposed infants: the impact of maternal ART use, infant mortality and replacement feeding risk. J Int AIDS Soc 21:e25107
Zheng, Amy; Kumarasamy, Nagalingeswaran; Huang, Mingshu et al. (2018) The cost-effectiveness and budgetary impact of a dolutegravir-based regimen as first-line treatment of HIV infection in India. J Int AIDS Soc 21:e25085
Rabideau, Dustin J; Pei, Pamela P; Walensky, Rochelle P et al. (2018) Implementing Generalized Additive Models to Estimate the Expected Value of Sample Information in a Microsimulation Model: Results of Three Case Studies. Med Decis Making 38:189-199
Paltiel, A David; Zheng, Amy; Weinstein, Milton C et al. (2017) Setting Performance Standards for a Cost-Effective Human Immunodeficiency Virus Cure Strategy in South Africa. Open Forum Infect Dis 4:ofx081
Bassett, Ingrid V; Coleman, Sharon M; Giddy, Janet et al. (2017) Barriers to Care and 1-Year Mortality Among Newly Diagnosed HIV-Infected People in Durban, South Africa. J Acquir Immune Defic Syndr 74:432-438

Showing the most recent 10 out of 33 publications