{"title":"Partner protections in HIV cure-related trials involving analytical treatment interruption: Updated toolkit to mitigate HIV transmission risk","authors":"","doi":"10.1016/j.jve.2024.100386","DOIUrl":null,"url":null,"abstract":"<div><div>Analytical treatment interruptions (ATIs) are widely used to evaluate HIV cure-related research interventions. However, sex partners of cure-related trial participants might be at risk of acquiring HIV during ATIs. Addressing this risk is key to ensuring the continued success of trials involving ATIs and offer greater acceptability across multiple trials sites. In 2022, the Advancing Clinical Therapeutics Globally (ACTG) Network convened a Partner Protections Working Group (PPWG) to update the 2020 HIV transmission risk toolkit developed by Peluso and colleagues. In our review of the original toolkit, we identified new challenges and needs at the participant, partner and study levels, as well as new evidence on measures to address these needs and more advanced ethical thinking on partner protections in HIV cure-related trials with ATIs. Based on these findings, we developed an updated toolkit that will provide trial participants and their partners with better support to address new and unfamiliar situations and protect partners from undue harm. We present this toolkit, make it available as a resource for cure-related trials with ATIs and discuss possible future directions.</div></div>","PeriodicalId":17552,"journal":{"name":"Journal of Virus Eradication","volume":null,"pages":null},"PeriodicalIF":3.5000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2055664024000232/pdfft?md5=4998fea798603048df3d77fc61673ab9&pid=1-s2.0-S2055664024000232-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Virus Eradication","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2055664024000232","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Analytical treatment interruptions (ATIs) are widely used to evaluate HIV cure-related research interventions. However, sex partners of cure-related trial participants might be at risk of acquiring HIV during ATIs. Addressing this risk is key to ensuring the continued success of trials involving ATIs and offer greater acceptability across multiple trials sites. In 2022, the Advancing Clinical Therapeutics Globally (ACTG) Network convened a Partner Protections Working Group (PPWG) to update the 2020 HIV transmission risk toolkit developed by Peluso and colleagues. In our review of the original toolkit, we identified new challenges and needs at the participant, partner and study levels, as well as new evidence on measures to address these needs and more advanced ethical thinking on partner protections in HIV cure-related trials with ATIs. Based on these findings, we developed an updated toolkit that will provide trial participants and their partners with better support to address new and unfamiliar situations and protect partners from undue harm. We present this toolkit, make it available as a resource for cure-related trials with ATIs and discuss possible future directions.
分析性治疗中断(ATI)被广泛用于评估与艾滋病治愈相关的研究干预措施。然而,与治愈相关的试验参与者的性伴侣可能有在 ATI 期间感染 HIV 的风险。解决这一风险是确保涉及 ATIs 的试验持续成功的关键,并能为多个试验点提供更高的可接受性。2022 年,全球推进临床治疗(ACTG)网络召集了合作伙伴保护工作组(PPWG),以更新 Peluso 及其同事开发的 2020 年 HIV 传播风险工具包。在对原始工具包的审查中,我们发现了参与者、伴侣和研究层面的新挑战和新需求,以及解决这些需求的措施的新证据和在使用 ATIs 的 HIV 治愈相关试验中伴侣保护方面更先进的伦理思想。基于这些发现,我们开发了一个更新的工具包,为试验参与者及其伴侣提供更好的支持,以应对新的和陌生的情况,并保护伴侣免受不必要的伤害。我们将介绍该工具包,将其作为ATIs治愈相关试验的资源,并讨论未来可能的发展方向。
期刊介绍:
The Journal of Virus Eradication aims to provide a specialist, open-access forum to publish work in the rapidly developing field of virus eradication. The Journal covers all human viruses, in the context of new therapeutic strategies, as well as societal eradication of viral infections with preventive interventions.
The Journal is aimed at the international community involved in the prevention and management of viral infections. It provides an academic forum for the publication of original research into viral reservoirs, viral persistence and virus eradication and ultimately development of cures.
The Journal not only publishes original research, but provides an opportunity for opinions, reviews, case studies and comments on the published literature. It focusses on evidence-based medicine as the major thrust in the successful management of viral infections.The Journal encompasses virological, immunological, epidemiological, modelling, pharmacological, pre-clinical and in vitro, as well as clinical, data including but not limited to drugs, immunotherapy and gene therapy. It is an important source of information on the development of vaccine programs and preventative measures aimed at virus eradication.