Facilitating next‐generation pre‐exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the Forum HIV Prevention Trial …

N Parkin, F Gao, E Grebe, A Cutrell… - Clinical …, 2023 - Wiley Online Library
Standard‐of‐care HIV pre‐exposure prophylaxis (PrEP) is highly efficacious, but uptake of
and persistence on a daily oral pill is low in many settings. Evaluation of alternate PrEP …

Initiation, discontinuation, and restarting HIV pre-exposure prophylaxis: ongoing implementation strategies

SE Rutstein, DK Smith, S Dalal, RC Baggaley… - The lancet HIV, 2020 - thelancet.com
When used appropriately, pre-exposure prophylaxis (PrEP) substantially reduces the risk of
HIV acquisition. Early implementation outcomes often suggest poor PrEP adherence and …

HIV prevention trial design in an era of effective pre-exposure prophylaxis

A Cutrell, D Donnell, DT Dunn, DV Glidden… - HIV clinical …, 2017 - Taylor & Francis
Pre-exposure prophylaxis (PrEP) has demonstrated remarkable effectiveness protecting at-
risk individuals from HIV-1 infection. Despite this record of effectiveness, concerns persist …

Amplifying the population health benefits of PrEP for HIV prevention

JM Baeten - The Journal of infectious diseases, 2018 - academic.oup.com
Pre-exposure prophylaxis (PrEP) prevents HIV infection. Robust evidence—first from pivotal
clinical trials [1, 2], then rigorous studies testing best-practice models of implementation [3 …

Sample size calculation for active-arm trial with counterfactual incidence based on recency assay

F Gao, DV Glidden, JP Hughes… - … in Infectious Diseases, 2021 - degruyter.com
Objectives The past decade has seen tremendous progress in the development of
biomedical agents that are effective as pre-exposure prophylaxis (PrEP) for HIV prevention …

A Bayesian averted infection framework for PrEP trials with low numbers of HIV infections: application to the results of the DISCOVER trial

DV Glidden, OT Stirrup, DT Dunn - The Lancet HIV, 2020 - thelancet.com
Trials of candidate agents for HIV pre-exposure prophylaxis (PrEP) might randomly assign
participants to be given a new PrEP agent or oral coformulated tenofovir disoproxil fumarate …

Has pre-exposure prophylaxis made a difference at a population level? Jury Is Still Out

JL Marcus, AD Paltiel… - Clinical Infectious Diseases, 2020 - academic.oup.com
Once-daily preexposure prophylaxis (PrEP) is up to 99% effective in reducing the risk of
human immunodeficiency virus (HIV) acquisition [1–5]. Although PrEP has been approved …

Regulatory perspectives for streamlining HIV prevention trials

JS Murray - Statistical Communications in Infectious Diseases, 2019 - degruyter.com
Designing and conducting active-controlled trials of HIV pre-exposure prophylaxis (PrEP)
therapeutics are becoming challenging due to inconsistency of adherence across trials and …

[HTML][HTML] HIV pre-exposure prophylaxis: scaling up for impact now and in the future

BR Bavinton, AE Grulich - The Lancet Public Health, 2021 - thelancet.com
More than a decade after the first efficacy evidence for oral HIV pre-exposure prophylaxis
(PrEP) was reported, PrEP uptake globally has been inadequate and global HIV prevention …

[HTML][HTML] Pre-exposure prophylaxis (PrEP) in an era of stalled HIV prevention: Can it change the game?

R Eakle, F Venter, H Rees - Retrovirology, 2018 - Springer
Pre-exposure prophylaxis (PrEP) for HIV prevention has evolved significantly over the years
where clinical trials have now demonstrated the efficacy of oral PrEP, and the field is scaling …