Control groups for HIV prevention efficacy trials: what does the future hold?
H Janes, S Buchbinder - Current Opinion in HIV and AIDS, 2023 - journals.lww.com
Efficacy trials of new HIV prevention interventions are feasible but require careful
consideration, given the complexity and dynamic state of the prevention field. While …
consideration, given the complexity and dynamic state of the prevention field. While …
Facilitating next‐generation pre‐exposure prophylaxis clinical trials using HIV recent infection assays: a consensus statement from the Forum HIV Prevention Trial …
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 …
and persistence on a daily oral pill is low in many settings. Evaluation of alternate PrEP …
Efficacy estimates of oral pre-exposure prophylaxis for HIV prevention in cisgender women with partial adherence
M Moore, S Stansfield, DJ Donnell, MC Boily… - Nature medicine, 2023 - nature.com
Pre-exposure prophylaxis (PrEP) with tenofovir (TFV) disoproxil fumarate and emtricitabine
administered orally daily is effective in preventing human immunodeficiency virus (HIV) …
administered orally daily is effective in preventing human immunodeficiency virus (HIV) …
Counterfactual estimation of efficacy against placebo for novel PrEP agents using external trial data: example of injectable cabotegravir and oral PrEP in women
Introduction Multiple antiretroviral agents have demonstrated efficacy for human
immunodeficiency virus (HIV) pre‐exposure prophylaxis (PrEP). As a result, clinical trials of …
immunodeficiency virus (HIV) pre‐exposure prophylaxis (PrEP). As a result, clinical trials of …
Estimating counterfactual placebo HIV incidence in HIV prevention trials without placebo arms based on markers of HIV exposure
Introduction Developing alternative approaches to evaluating absolute efficacy of new HIV
prevention interventions is a priority, as active-controlled designs, whereby individuals …
prevention interventions is a priority, as active-controlled designs, whereby individuals …
[HTML][HTML] Interpretation of active-control randomised trials: the case for a new analytical perspective involving averted events
DT Dunn, OT Stirrup, S McCormack… - BMC Medical Research …, 2023 - Springer
Active-control trials, where an experimental treatment is compared with an established
treatment, are performed when the inclusion of a placebo control group is deemed to be …
treatment, are performed when the inclusion of a placebo control group is deemed to be …
[HTML][HTML] A web-based decision aid for caregivers of persons with dementia with firearm access (Safe at Home Study): protocol for a randomized controlled trial
V McCarthy, J Portz, SM Fischer… - JMIR research …, 2023 - researchprotocols.org
Background Firearm safety among individuals with Alzheimer disease and related
dementias (ADRD) is an underdiscussed and underresearched concern in the United …
dementias (ADRD) is an underdiscussed and underresearched concern in the United …
Generalizing the intention-to-treat effect of an active control from historical placebo-controlled trials: A case study of the efficacy of daily oral TDF/FTC in the HPTN 084 …
In many clinical settings, an active-controlled trial design (eg, a non-inferiority or superiority
design) is often used to compare an experimental medicine to an active control (eg, an FDA …
design) is often used to compare an experimental medicine to an active control (eg, an FDA …
HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo
Background While noninferiority of tenofovir alafenamide and emtricitabine (TAF/FTC) as
preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) …
preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) …
Bridged treatment comparisons: an illustrative application in HIV treatment
Comparisons of treatments or exposures are of central interest in epidemiology, but direct
comparisons are not always possible due to practical or ethical reasons. Here, we detail a …
comparisons are not always possible due to practical or ethical reasons. Here, we detail a …