Related papers: Active-Controlled Trial Design for HIV Prevention …
The past decade has seen tremendous progress in the development of biomedical agents that are effective as pre-exposure prophylaxis (PrEP) for HIV prevention. To expand the choice of products and delivery methods, new medications and…
With the advent of effective pre-exposure prophylaxis agents, active-controlled HIV prevention trials have become a common study design. Nevertheless, estimating absolute efficacy relative to a placebo remains important. In this paper, we…
Active-controlled trials with non-inferiority objectives are often used when effective interventions are available, but new options may offer advantages or meet public health needs. In these trials, participants are randomized to an…
Pre-exposure prophylaxis (PrEP) consists in the use of an antiretroviral medication to prevent the acquisition of HIV infection by uninfected individuals and has recently demonstrated to be highly efficacious for HIV prevention. We propose…
Controlling an epidemiological model is often performed using optimal control theory techniques for which the solution depends on the equations of the control system, objective functional and possible state and/or control constraints. In…
Anti-retroviral drugs can reduce the infectiousness of people living with HIV by about 96%--treatment as prevention or TasP--and can reduce the risk of being infected by an HIV positive person by about 70%--pre-exposure prophylaxis or…
Sexual contacts are the main spreading route of HIV. This puts sex workers at higher risk of infection even in populations where HIV prevalence is moderate or low. Alongside condom use, Pre-Exposure Prophylaxis (PrEP) is an effective tool…
HIV pre-exposure Prophylaxis (PrEP) has become essential for global HIV control, but its implementation coincides with rising bacterial STI rates among men who have sex with men (MSM). While risk-compensation behavioral changes like reduced…
Cross-sectional incidence estimation based on recency testing has become a widely used tool in HIV research. Recently, this method has gained prominence in HIV prevention trials to estimate the "placebo" incidence that participants might…
Pre-exposure prophylaxis (PrEP) is an effective intervention for preventing HIV transmission, but high cost and uneven uptake raise challenges for resource allocation. While spillover effects, wherein PrEP use in one group reduces…
In many clinical settings, an active-controlled trial design (e.g., a non-inferiority or superiority design) is often used to compare an experimental medicine to an active control (e.g., an FDA-approved, standard therapy). One prominent…
A central challenge in Human Immunodeficiency Virus (HIV) public health policy lies in determining whether to universally expand treatment access, despite the risk of sub-optimal adherence and consequent drug resistance, or to adopt a more…
TechStep is a randomized trial of a mobile health interventions targeted towards transgender adolescents. The interventions include a short message system, a mobile-optimized web application, and electronic counseling. The primary outcomes…
This paper is about numerical control of HIV propagation. The contribution of the paper is threefold: first, a novel model of HIV propagation is proposed; second, the methods from numerical optimal control are successfully applied to the…
HIV pre-exposure prophylaxis (PrEP) drastically reduces the risk of HIV infection if taken as prescribed, providing almost perfect protection even during unprotected sexual intercourse. Although this has been transformative in reducing new…
Four randomized placebo-controlled efficacy trials of a candidate vaccine or passively infused monoclonal antibody for prevention of HIV-1 infection are underway (HVTN 702 in South African men and women; HVTN 705 in sub-Saharan African…
The development of potent drugs for the control of viraemia in people living with HIV means that infected people may live a normal, healthy life and offers the prospect of eliminating HIV transmission in the short term and HIV infection in…
A key objective in two phase 2b AMP clinical trials of VRC01 is to evaluate whether drug concentration over time, as estimated by non-linear mixed effects pharmacokinetics (PK) models, is associated with HIV infection rate. We conducted a…
The government's effort to alleviate HIV stigma has been justified by the suppression effect of stigma on the HIV testing rate. Nevertheless, the deterrence effect of stigma on undesirable sexual behaviours has long been overlooked. This…
Adaptive experimental design methods are increasingly being used in industry as a tool to boost testing throughput or reduce experimentation cost relative to traditional A/B/N testing methods. This paper shares lessons learned regarding the…