Comput. Biol. Med. - Use of agent-based simulations to design and interpret HIV clinical trials.


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In this study, we illustrate the utility of an agent-based simulation to inform a trial design and how this supports outcome interpretation of randomized controlled trials (RCTs). We developed agent-based Monte Carlo models to simulate existing landmark HIV RCTs, such as the Partners in Prevention HSV/HIV Transmission Study. We simulated a variation of this study using valacyclovir therapy as the intervention, and we used a male circumcision RCT based on the Rakai Male Circumcision Trial. Our results indicate that a small fraction (20%) of the simulated Partners in Prevention HSV/HIV Transmission Study realizations rejected the null hypothesis, which was no effect from the intervention. Our results also suggest that an RCT designed to evaluate the effectiveness of a more potent drug regimen for HSV-2 suppression (valacyclovir therapy) is more likely to identify the efficacy of the intervention. For the male circumcision RCT simulation, the greater biological effect of the male circumcision yielded a major fraction (81%) of RCT realizations' that rejects the null hypothesis, which was no effect from the intervention. Our study highlights how agent-based simulations synthesize individual variation in the epidemiological context of the RCT. This methodology will be particularly useful for designing RCTs aimed at evaluating combination prevention interventions in community-based RCTs, wherein an interventions effectiveness is challenging to predict.

Resumo Limpo

studi illustr util agentbas simul inform trial design support outcom interpret random control trial rcts develop agentbas mont carlo model simul exist landmark hiv rcts partner prevent hsvhiv transmiss studi simul variat studi use valacyclovir therapi intervent use male circumcis rct base rakai male circumcis trial result indic small fraction simul partner prevent hsvhiv transmiss studi realiz reject null hypothesi effect intervent result also suggest rct design evalu effect potent drug regimen hsv suppress valacyclovir therapi like identifi efficaci intervent male circumcis rct simul greater biolog effect male circumcis yield major fraction rct realiz reject null hypothesi effect intervent studi highlight agentbas simul synthes individu variat epidemiolog context rct methodolog will particular use design rcts aim evalu combin prevent intervent communitybas rcts wherein intervent effect challeng predict

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