Abstract
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 intervention[U+05F3]s effectiveness is challenging to predict.
| Original language | English |
|---|---|
| Pages (from-to) | 1-8 |
| Number of pages | 8 |
| Journal | Computers in Biology and Medicine |
| Volume | 50 |
| DOIs | |
| Publication status | Published - 1 Jul 2014 |
| Externally published | Yes |
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Keywords
- Agent-based simulation
- Clinical trial
- HIV
- HIV treatment and prevention
- Mathematical modeling
ASJC Scopus subject areas
- Computer Science Applications
- Health Informatics
- Medicine(all)
Cite this
Use of agent-based simulations to design and interpret HIV clinical trials. / Cuadros, Diego F.; Aburaddad, Laith; Awad, Susanne; García-Ramos, Gisela.
In: Computers in Biology and Medicine, Vol. 50, 01.07.2014, p. 1-8.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Use of agent-based simulations to design and interpret HIV clinical trials
AU - Cuadros, Diego F.
AU - Aburaddad, Laith
AU - Awad, Susanne
AU - García-Ramos, Gisela
PY - 2014/7/1
Y1 - 2014/7/1
N2 - 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 intervention[U+05F3]s effectiveness is challenging to predict.
AB - 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 intervention[U+05F3]s effectiveness is challenging to predict.
KW - Agent-based simulation
KW - Clinical trial
KW - HIV
KW - HIV treatment and prevention
KW - Mathematical modeling
UR - http://www.scopus.com/inward/record.url?scp=84899819559&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84899819559&partnerID=8YFLogxK
U2 - 10.1016/j.compbiomed.2014.03.008
DO - 10.1016/j.compbiomed.2014.03.008
M3 - Article
VL - 50
SP - 1
EP - 8
JO - Computers in Biology and Medicine
JF - Computers in Biology and Medicine
SN - 0010-4825
ER -