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Factors associated with PrEP-era HIV seroconversion in a 4-year U.S. national cohort of n = 6059 sexual and gender minority individuals who have sex with men, 2017−2022 2017-2022 年,在 n = 6059 名性与性别少数群体男男性行为者的 4 年美国全国队列中,与 PrEP 时期艾滋病毒血清转换相关的因素
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-06-25 DOI: 10.1002/jia2.26312
Christian Grov, Yan Guo, Drew A. Westmoreland, Alexa B. D'Angelo, Chloe Mirzayi, Michelle Dearolf, Pedro Carneiro, Meredith Ray, David Pantalone, Adam W. Carrico, Viraj V. Patel, Sarit A. Golub, Sabina Hirshfield, Donald R. Hoover, Denis Nash
<div> <section> <h3> Introduction</h3> <p>Community-based cohort studies of HIV seroconversion can identify important avenues for enhancing HIV prevention efforts in the era of pre-exposure prophylaxis (PrEP). Within individuals, one can assess exposure and outcome variables repeatedly and with increased certainty regarding temporal ordering. This cohort study examined the association of several risk factors with subsequent HIV seroconversion.</p> </section> <section> <h3> Methods</h3> <p>We report data from a 4-year study (2017−2022) of 6059 HIV seronegative sexual and gender minority individuals who have sex with men who had indications for-, but were not using-, PrEP at enrolment. Participants completed repeat exposure assessments and self-collection of biospecimens for HIV testing. We examined the roles of race and ethnicity, socio-economic status, methamphetamine use and PrEP uptake over the course of follow-up in relation to HIV seroconversion.</p> </section> <section> <h3> Results</h3> <p>Over 4 years, 303 of the participants seroconverted across 18,421 person-years (incidence rate = 1.64 [95% CI: 1.59−1.70] per 100 person-years). In multivariable discrete-time survival analysis, factors independently associated with elevated HIV seroconversion risk included being Black/African American (adjusted risk ratio [aRR]: 2.44, 1.79−3.28), Hispanic/Latinx (1.53, 1.19−1.96), housing instability (1.58, 1.22−2.05) and past year methamphetamine use (3.82, 2.74−5.33). Conversely, time since study enrolment (24 vs. 12 months, 0.67, 0.51−0.87; 36 months, 0.60, 0.45−0.80; 48 months, 0.48, 0.35−0.66) and higher education (master's degree or higher vs. less than or equal to high school, 0.36, 0.17−0.66) were associated with reduced seroconversion risk. Compared to non-PrEP users in the past 2 years without a current clinical indication, those who started PrEP but then discontinued had higher seroconversion risk, irrespective of clinical indication (3.23, 1.74−6.46) or lack thereof (4.30, 1.85−9.88). However, those who initiated PrEP in the past year (0.14, 0.04−0.39) or persistently used PrEP in the past 2 years (0.33, 0.14−0.74) had a lower risk of seroconversion. Of all HIV seroconversions observed during follow-up assessments (12, 24, 36 and 48 months), methamphetamine was reported in the 12 months <i>prior</i> 128 (42.2%) times (overall).</p> </section> <section> <h3> Conclusions</h3> <p>Interventions that acknowledge race and ethnicity, economic variables such as education and housing instability, and methamphetamine use are critically needed. Not only a
引言 以社区为基础的艾滋病血清转换队列研究可以确定在暴露前预防疗法(PrEP)时代加强艾滋病预防工作的重要途径。在个体内部,我们可以重复评估暴露和结果变量,并提高时间排序的确定性。这项队列研究考察了几个风险因素与后续 HIV 血清转换的关系。 方法 我们报告了一项为期 4 年(2017-2022 年)的研究数据,研究对象是 6059 名 HIV 血清阴性的性少数群体和性别少数群体男男性行为者,他们在入组时具有 PrEP 适应症,但并未使用 PrEP。参与者完成了重复暴露评估和自我采集生物样本进行 HIV 检测。我们研究了种族和民族、社会经济地位、甲基苯丙胺使用情况以及在随访过程中使用 PrEP 与 HIV 血清转换之间的关系。 结果 4 年间,303 名参与者在 18,421 人年中发生了血清转换(发生率 = 1.64 [95% CI: 1.59-1.70]/100人年)。在多变量离散时间生存分析中,与 HIV 血清转换风险升高独立相关的因素包括黑人/非裔美国人(调整风险比 [aRR]:2.44,1.79-3.28)、西班牙裔/拉丁裔(1.53,1.19-1.96)、住房不稳定(1.58,1.22-2.05)和过去一年使用甲基苯丙胺(3.82,2.74-5.33)。与此相反,加入研究的时间(24 个月对 12 个月,0.67,0.51-0.87;36 个月,0.60,0.45-0.80;48 个月,0.48,0.35-0.66)和高等教育程度(硕士学位或更高对高中以下,0.36,0.17-0.66)与血清转换风险降低有关。与过去两年中未使用过 PrEP 但目前没有临床指征的人相比,那些开始使用 PrEP 但后来又停止使用的人血清转换风险更高,无论是否有临床指征(3.23,1.74-6.46)或没有临床指征(4.30,1.85-9.88)。然而,在过去一年中开始使用 PrEP(0.14,0.04-0.39)或在过去两年中持续使用 PrEP(0.33,0.14-0.74)的人血清转换风险较低。在随访评估期间(12、24、36 和 48 个月)观察到的所有艾滋病毒血清转换者中,有 128 人(42.2%)报告在 12 个月前吸食过甲基苯丙胺(总体)。 结论 急需采取干预措施,承认种族和民族、经济变量(如教育和住房不稳定性)以及甲基苯丙胺的使用。不仅需要采取干预措施让个人参与 PrEP 治疗,而且鉴于这些群体中血清转换的风险极高,还必须采取干预措施留住他们,并让那些可能脱离治疗的人重新参与治疗。
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引用次数: 0
Including transgender populations in mathematical models for HIV treatment and prevention: current barriers and policy implications 将变性人纳入艾滋病治疗和预防数学模型:当前的障碍和政策影响。
IF 6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-06-12 DOI: 10.1002/jia2.26304
Diana M. Tordoff, Arjee Restar, Brian Minalga, Atlas Fernandez, Dobromir Dimitrov, Ann Duerr, the Seattle Trans and Nonbinary Sexual Health (STARS) Advisory Board
<div> <section> <h3> Introduction</h3> <p>Mathematical models of HIV have been uniquely important in directing and evaluating HIV policy. Transgender and nonbinary people are disproportionately impacted by HIV; however, few mathematical models of HIV transmission have been published that are inclusive of transgender and nonbinary populations. This commentary discusses current structural challenges to developing robust and accurate trans-inclusive models and identifies opportunities for future research and policy, with a focus on examples from the United States.</p> </section> <section> <h3> Discussion</h3> <p>As of April 2024, only seven published mathematical models of HIV transmission include transgender people. Existing models have several notable limitations and biases that limit their utility for informing public health intervention. Notably, no models include transgender men or nonbinary individuals, despite these populations being disproportionately impacted by HIV relative to cisgender populations. In addition, existing mathematical models of HIV transmission do not accurately represent the sexual network of transgender people. Data availability and quality remain a significant barrier to the development of accurate trans-inclusive mathematical models of HIV. Using a community-engaged approach, we developed a modelling framework that addresses the limitations of existing model and to highlight how data availability and quality limit the utility of mathematical models for transgender populations.</p> </section> <section> <h3> Conclusions</h3> <p>Modelling is an important tool for HIV prevention planning and a key step towards informing public health interventions, programming and policies for transgender populations. Our modelling framework underscores the importance of accurate trans-inclusive data collection methodologies, since the relevance of these analyses for informing public health decision-making is strongly dependent on the validity of the model parameterization and calibration targets. Adopting gender-inclusive and gender-specific approaches starting from the development and data collection stages of research can provide insights into how interventions, programming and policies can distinguish unique health needs across all gender groups. Moreover, in light of the data structure limitations, designing longitudinal surveillance data systems and probability samples will be critical to fill key research gaps, highlight progress and provide additional rigour to the current evidence. Investments and initiatives like Ending the HIV Epidemic in the United States can be further expanded and are highly needed to prioritize and value transg
导言:艾滋病毒的数学模型在指导和评估艾滋病毒政策方面具有独特的重要性。变性人和非二元人群受到艾滋病毒的影响尤为严重;然而,目前已发表的艾滋病毒传播数学模型中,很少包含变性人和非二元人群。这篇评论以美国的实例为重点,讨论了当前在开发强大而准确的跨性别包容性模型方面所面临的结构性挑战,并指出了未来研究和政策的机遇:截至 2024 年 4 月,仅有七个已发表的艾滋病毒传播数学模型包含变性人。现有模型存在一些明显的局限性和偏差,限制了其为公共卫生干预提供信息的效用。值得注意的是,没有任何模型包括变性男性或非二元个人,尽管这些人群受到艾滋病毒的影响比顺性人群更大。此外,现有的 HIV 传播数学模型并不能准确地代表变性人的性网络。数据的可用性和质量仍然是开发准确的跨性别艾滋病毒数学模型的重大障碍。利用社区参与的方法,我们开发了一个建模框架,以解决现有模型的局限性,并强调数据可用性和质量如何限制了数学模型对跨性别人群的实用性:建模是艾滋病毒预防规划的重要工具,也是为变性人群体的公共卫生干预措施、规划和政策提供信息的关键步骤。我们的建模框架强调了准确的跨性别数据收集方法的重要性,因为这些分析对公共卫生决策的相关性在很大程度上取决于模型参数化和校准目标的有效性。从研究的开发和数据收集阶段开始,就采用性别包容和性别特定的方法,可以深入了解干预措施、计划和政策如何区分所有性别群体的独特健康需求。此外,鉴于数据结构的局限性,设计纵向监测数据系统和概率样本对于填补关键研究空白、突出进展和为现有证据提供更多严谨性至关重要。像美国 "消除艾滋病毒流行 "这样的投资和倡议可以进一步扩大,而且亟需在各种供资结构、目标和成果措施中优先考虑和重视跨性别人群。
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引用次数: 0
HIV self-testing in India: implementation and qualitative evaluation of a web-based programme with virtual counsellor support 印度的艾滋病毒自我检测:基于网络的虚拟顾问支持计划的实施和定性评估。
IF 6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-06-11 DOI: 10.1002/jia2.26302
Rose Pollard Kaptchuk, Jalpa Thakker, Jade Bell, Saya Okram, Usha Gopinath, Shruti H. Mehta, Ajay Kumar Reddy, Talia A. Loeb, Visvanathan Arumugam, Samit Tandon, Mugundu Ramien Parthasarathy, Subash Chandra Ghosh, Aditya Singh, Deepika Srivastava Joshi, Sukhvinder Kaur, Sunil Suhas Solomon, Allison M. McFall
<div> <section> <h3> Introduction</h3> <p>To achieve epidemic control of infectious diseases, engaging higher-burden populations with accessible diagnostic services is critical. HIV self-testing (HIVST) is a promising option.</p> </section> <section> <h3> Methods</h3> <p>We implemented an online HIVST programme for key populations across India. Eligible clients were 18 years or older, self-reported a negative or unknown HIV status and reported not taking antiretroviral therapy. Clients who reported a prior HIV diagnosis were not eligible to receive an HIVST kit. HIVST clients received kits via courier or in person at pre-determined pick-up points supported by trained counselling staff. Virtual counsellors engaged clients online and by phone and offered support to register, access, and complete HIVST free of cost. Virtual counsellors supported clients to report results and engage with follow-up services. Follow-up included linking clients with a positive result to confirmatory testing and HIV care services. We assessed programmatic data across HIV continuum outcomes and conducted a qualitative evaluation through interviews with purposively sampled clients.</p> </section> <section> <h3> Results</h3> <p>Between 30 June 2021 and 30 September 2022, 5324 clients ordered an HIVST kit (76% men, 13% women, 7% transgender people, 4% unknown gender). Of the 4282 clients reporting results (94% of those who received a kit), 6% screened positive, among whom 72% (<i>n</i> = 184) completed confirmatory testing. Themes from 41 client interviews included satisfaction about the convenience and privacy of services and the discreet nature of kit delivery. Respondents were drawn to the convenience of HIVST and appreciated gaining courage and comfort throughout the process from virtual counsellor support. For respondents who screened positive, challenges to care linkage included fearing judgemental questions from public providers and wanting more time before starting treatment. Clients shared concerns about kit accuracy and suggested that instructional materials be provided with more diverse language options.</p> </section> <section> <h3> Conclusions</h3> <p>Web-based HIVST services with tailored support appeared to facilitate HIV service access and engagement of harder-to-reach populations across India. Assistance from a community-oriented counsellor proved important to overcome literacy barriers and mistrust  in order to support the HIVST process and service linkage. Learnings can inform global efforts to improve the critical step of diagnosis in achieving epidemic con
导言:要实现传染病的流行控制,让负担较重的人群获得便捷的诊断服务至关重要。艾滋病毒自我检测(HIVST)是一个很有前景的选择:方法:我们在印度各地为重点人群实施了一项在线 HIVST 计划。符合条件的客户年龄在 18 岁或以上,自我报告的 HIV 检测结果为阴性或未知,并报告未接受抗逆转录病毒治疗。曾报告过艾滋病毒诊断结果的客户没有资格领取艾滋病毒检测试剂盒。在经过培训的咨询人员的支持下,HIVST 客户通过快递或亲自到预先确定的领取点领取工具包。虚拟咨询人员通过网络和电话与客户联系,并免费提供注册、获取和完成 HIVST 的支持。虚拟辅导员帮助客户报告结果并参与后续服务。后续服务包括将结果呈阳性的客户与确证检测和 HIV 护理服务联系起来。我们评估了整个 HIV 连续性结果的计划数据,并通过有目的抽样客户访谈进行了定性评估:2021 年 6 月 30 日至 2022 年 9 月 30 日期间,5324 名客户订购了 HIVST 套件(76% 为男性,13% 为女性,7% 为变性人,4% 为性别未知者)。在报告结果的 4282 名客户中(94% 收到试剂盒的客户),6% 筛选结果呈阳性,其中 72%(n = 184)完成了确证检测。41 次客户访谈的主题包括对服务的便利性和私密性以及试剂盒交付的谨慎性表示满意。受访者被 HIVST 的便利性所吸引,并赞赏在整个过程中从虚拟顾问支持中获得的勇气和舒适感。对于筛查结果呈阳性的受访者而言,护理联系面临的挑战包括害怕公共医疗服务提供者提出评判性的问题,以及希望在开始治疗前有更多的时间。受试者也对试剂盒的准确性表示担忧,并建议提供更多语言选择的指导材料:基于网络的 HIVST 服务以及量身定制的支持似乎有助于印度各地较难接触到的人群获得 HIV 服务并参与其中。事实证明,以社区为导向的辅导员的协助对于克服识字障碍和不信任以支持 HIVST 过程和服务连接非常重要。所学到的知识可为全球努力改进诊断这一关键步骤提供参考,以实现对艾滋病毒和其他传染病的流行控制。
{"title":"HIV self-testing in India: implementation and qualitative evaluation of a web-based programme with virtual counsellor support","authors":"Rose Pollard Kaptchuk,&nbsp;Jalpa Thakker,&nbsp;Jade Bell,&nbsp;Saya Okram,&nbsp;Usha Gopinath,&nbsp;Shruti H. Mehta,&nbsp;Ajay Kumar Reddy,&nbsp;Talia A. Loeb,&nbsp;Visvanathan Arumugam,&nbsp;Samit Tandon,&nbsp;Mugundu Ramien Parthasarathy,&nbsp;Subash Chandra Ghosh,&nbsp;Aditya Singh,&nbsp;Deepika Srivastava Joshi,&nbsp;Sukhvinder Kaur,&nbsp;Sunil Suhas Solomon,&nbsp;Allison M. McFall","doi":"10.1002/jia2.26302","DOIUrl":"10.1002/jia2.26302","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Introduction&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;To achieve epidemic control of infectious diseases, engaging higher-burden populations with accessible diagnostic services is critical. HIV self-testing (HIVST) is a promising option.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;We implemented an online HIVST programme for key populations across India. Eligible clients were 18 years or older, self-reported a negative or unknown HIV status and reported not taking antiretroviral therapy. Clients who reported a prior HIV diagnosis were not eligible to receive an HIVST kit. HIVST clients received kits via courier or in person at pre-determined pick-up points supported by trained counselling staff. Virtual counsellors engaged clients online and by phone and offered support to register, access, and complete HIVST free of cost. Virtual counsellors supported clients to report results and engage with follow-up services. Follow-up included linking clients with a positive result to confirmatory testing and HIV care services. We assessed programmatic data across HIV continuum outcomes and conducted a qualitative evaluation through interviews with purposively sampled clients.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Between 30 June 2021 and 30 September 2022, 5324 clients ordered an HIVST kit (76% men, 13% women, 7% transgender people, 4% unknown gender). Of the 4282 clients reporting results (94% of those who received a kit), 6% screened positive, among whom 72% (&lt;i&gt;n&lt;/i&gt; = 184) completed confirmatory testing. Themes from 41 client interviews included satisfaction about the convenience and privacy of services and the discreet nature of kit delivery. Respondents were drawn to the convenience of HIVST and appreciated gaining courage and comfort throughout the process from virtual counsellor support. For respondents who screened positive, challenges to care linkage included fearing judgemental questions from public providers and wanting more time before starting treatment. Clients shared concerns about kit accuracy and suggested that instructional materials be provided with more diverse language options.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusions&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Web-based HIVST services with tailored support appeared to facilitate HIV service access and engagement of harder-to-reach populations across India. Assistance from a community-oriented counsellor proved important to overcome literacy barriers and mistrust  in order to support the HIVST process and service linkage. Learnings can inform global efforts to improve the critical step of diagnosis in achieving epidemic con","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"27 6","pages":""},"PeriodicalIF":6.0,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26302","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141305041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Preventing tuberculosis with community-based care in an HIV-endemic setting: a modelling analysis 在艾滋病毒流行的环境中通过社区护理预防结核病:模型分析。
IF 6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-06-11 DOI: 10.1002/jia2.26272
Jennifer M. Ross, Chelsea Greene, Cara J. Broshkevitch, David W. Dowdy, Alastair van Heerden, Jesse Heitner, Darcy W. Rao, D. Allen Roberts, Adrienne E. Shapiro, Zelda B. Zabinsky, Ruanne V. Barnabas

Introduction

Antiretroviral therapy (ART) and tuberculosis preventive treatment (TPT) both prevent tuberculosis (TB) disease and deaths among people living with HIV. Differentiated care models, including community-based care, can increase the uptake of ART and TPT to prevent TB in settings with a high burden of HIV-associated TB, particularly among men.

Methods

We developed a gender-stratified dynamic model of TB and HIV transmission and disease progression among 100,000 adults ages 15−59 in KwaZulu-Natal, South Africa. We drew model parameters from a community-based ART initiation and resupply trial in sub-Saharan Africa (Delivery Optimization for Antiretroviral Therapy, DO ART) and other scientific literature. We simulated the impacts of community-based ART and TPT care programmes during 2018−2027, assuming that community-based ART and TPT care were scaled up to similar levels as in the DO ART trial (i.e. ART coverage increasing from 49% to 82% among men and from 69% to 83% among women) and sustained for 10 years. We projected the number of TB cases, deaths and disability-adjusted life years (DALYs) averted relative to standard, clinic-based care. We calculated programme costs and incremental cost-effectiveness ratios from the provider perspective.

Results

If community-based ART care could be implemented with similar effectiveness to the DO ART trial, increased ART coverage could reduce TB incidence by 27.0% (range 21.3%−34.1%) and TB mortality by 34.6% (range 24.8%–42.2%) after 10 years. Increasing both ART and TPT uptake through community-based ART with TPT care could reduce TB incidence by 29.7% (range 23.9%−36.0%) and TB mortality by 36.0% (range 26.9%−43.8%). Community-based ART with TPT care reduced gender disparities in TB mortality rates, with a projected 54 more deaths annually among men than women (range 11–103) after 10 years of community-based care versus 109 (range 41–182) in standard care. Over 10 years, the mean cost per DALY averted by community-based ART with TPT care was $846 USD (range $709–$1012).

Conclusions

By substantially increasing coverage of ART and TPT, community-based care for people living with HIV could reduce TB incidence and mortality in settings with high burdens of HIV-associated TB and reduce TB gender disparities.

导言:抗逆转录病毒疗法(ART)和结核病预防治疗(TPT)都能预防结核病和艾滋病病毒感染者的死亡。包括社区护理在内的差异化护理模式可以提高抗逆转录病毒疗法和结核病预防治疗的使用率,从而在艾滋病相关结核病负担较重的环境中预防结核病,尤其是在男性中:我们在南非夸祖鲁-纳塔尔省 10 万名 15-59 岁的成年人中建立了一个结核病和 HIV 传播及疾病进展的性别分层动态模型。我们从撒哈拉以南非洲的一项基于社区的抗逆转录病毒疗法启动和再供给试验(抗逆转录病毒疗法的优化交付,DO ART)和其他科学文献中提取了模型参数。我们模拟了 2018-2027 年期间社区抗逆转录病毒疗法和 TPT 护理计划的影响,假设社区抗逆转录病毒疗法和 TPT 护理扩大到与 DO ART 试验类似的水平(即男性抗逆转录病毒疗法覆盖率从 49% 提高到 82%,女性从 69% 提高到 83%),并持续 10 年。我们预测了相对于标准诊所治疗而言所避免的结核病例数、死亡人数和残疾调整生命年数。我们从提供者的角度计算了项目成本和增量成本效益比:如果社区抗逆转录病毒疗法的实施效果与 DO 抗逆转录病毒疗法试验相似,那么在 10 年后,抗逆转录病毒疗法覆盖率的提高可使结核病发病率降低 27.0%(范围为 21.3%-34.1%),结核病死亡率降低 34.6%(范围为 24.8%-42.2%)。通过基于社区的抗逆转录病毒疗法和 TPT 护理,提高抗逆转录病毒疗法和 TPT 的使用率,可使结核病发病率降低 29.7%(范围为 23.9%-36.0%),结核病死亡率降低 36.0%(范围为 26.9%-43.8%)。基于社区的抗逆转录病毒疗法和 TPT 治疗减少了结核病死亡率的性别差异,预计在基于社区的治疗 10 年后,每年男性死亡人数比女性多 54 人(范围为 11-103 人),而标准治疗每年死亡人数为 109 人(范围为 41-182)。10 年间,社区抗逆转录病毒疗法和 TPT 治疗可避免的每 DALY 平均成本为 846 美元(范围在 709 美元至 1012 美元之间):结论:通过大幅提高抗逆转录病毒疗法和 TPT 的覆盖率,对艾滋病病毒感染者进行社区护理可降低艾滋病相关结核病高负担地区的结核病发病率和死亡率,并减少结核病的性别差异。
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引用次数: 0
Reducing stigma and promoting HIV wellness/mental health of sexual and gender minorities: RCT results from a group-based programme in Nigeria 减少性少数群体和性别少数群体的污名化并促进其艾滋病毒健康/心理健康:尼日利亚一项以群体为基础的计划的 RCT 结果
IF 6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-06-05 DOI: 10.1002/jia2.26256
Julie Pulerwitz, Ann Gottert, Waimar Tun, Anita Fernandez Eromhonsele, Progress Lanre Oladimeji, Elizabeth Shoyemi, Mauton Akoro, Columbus Ndeloa, Adebola Adedimeji
<div> <section> <h3> Introduction</h3> <p>High levels of HIV stigma as well as stigma directed towards sexual and/or gender minorities (SGMs) are well documented in the African setting. These intersecting stigmas impede psychosocial wellbeing and HIV prevention and care. Yet, there are few if any evidence-based interventions that focus on reducing internalized stigma and promoting mental health and HIV wellness for SGMs in Africa. We developed and evaluated a group-based intervention drawing on cognitive behavioural therapy (CBT) strategies for men who have sex with men (MSM) and transgender women (TGW) at risk for or living with HIV in Lagos, Nigeria.</p> </section> <section> <h3> Methods</h3> <p>The intervention comprised four weekly in-person group sessions facilitated by community health workers. We conducted a delayed intervention group randomized controlled trial (April−September 2022), with pre-post surveys plus 3-month follow-up (immediate group only), as well as qualitative research with participants and programme staff. Outcomes included internalized stigma related to SGM and HIV status, depression, resiliency/coping and pre-exposure prophylaxis (PrEP)/HIV treatment use.</p> </section> <section> <h3> Results</h3> <p>Mean age of the 240 participants was 26 years (range 18−42). Seventy-seven percent self-identified as MSM and 23% TGW; 27% were people with HIV. Most (88%) participants attended all four sessions, and 98% expressed high intervention satisfaction. There was significant pre-post improvement in each psychosocial outcome, in both the immediate and delayed arms. There were further positive changes for the immediate intervention group by 3-month follow-up (e.g. in intersectional internalized stigma, depression). While baseline levels of ever-PrEP use were the same, 75% of immediate-group participants reported currently using PrEP at 3 months post-intervention versus 53% of delayed-group participants right after the intervention (<i>p</i><0.01). Participants post-intervention described (in qualitative interviews) less self-blame, and enhanced social support and resilience when facing stigma, as well as motivation to use PrEP, and indicated that positive pre-intervention changes in psychosocial factors found in the delayed group mainly reflected perceived support from the study interviewers.</p> </section> <section> <h3> Conclusions</h3> <p>This study demonstrated the feasibility and acceptability of a group-based CBT model for MSM and TGW in Nigeria. There were also some indications of positive shifts related to stigma, mental hea
导言:在非洲地区,艾滋病毒以及针对性和/或性别少数群体(SGMs)的污名化程度很高。这些相互交织的污名阻碍了社会心理健康和艾滋病预防与护理。然而,以证据为基础的干预措施很少(如果有的话),这些干预措施的重点是减少内化的污名,促进非洲 SGMs 的心理健康和 HIV 健康。我们借鉴认知行为疗法(CBT)策略,为尼日利亚拉各斯的高危男男性行为者(MSM)和变性女性(TGW)制定并评估了一项基于小组的干预措施。 方法 干预包括每周四次由社区卫生工作者主持的面对面小组会议。我们开展了一项延迟干预小组随机对照试验(2022 年 4 月至 9 月),并进行了事后调查和 3 个月的随访(仅限即时小组),还对参与者和项目工作人员进行了定性研究。研究结果包括与 SGM 和 HIV 感染状况相关的内在化污名化、抑郁、复原力/应对能力以及暴露前预防 (PrEP) / HIV 治疗的使用情况。 结果 240 名参与者的平均年龄为 26 岁(18-42 岁不等)。77%的参与者自我认同为 MSM,23%为 TGW;27%为 HIV 感染者。大多数参与者(88%)参加了全部四个疗程,98%的参与者对干预表示高度满意。立即干预组和延迟干预组的每项社会心理结果在干预前都有明显改善。在 3 个月的随访中,即时干预组还出现了进一步的积极变化(如在交叉内化污名、抑郁方面)。虽然曾经使用过 PrEP 的基线水平相同,但在干预后 3 个月,75% 的即时干预组参与者表示目前正在使用 PrEP,而在干预后,53% 的延迟干预组参与者表示目前正在使用 PrEP(p<0.01)。干预后的参与者(在定性访谈中)描述了在面对污名时较少的自责、更强的社会支持和复原力,以及使用 PrEP 的动机,并表示延迟组在干预前发现的心理社会因素的积极变化主要反映了研究访谈者提供的支持。 结论 本研究证明了针对尼日利亚男男性行为者和女性同性恋者的以小组为基础的 CBT 模式的可行性和可接受性。尽管在这一具有挑战性的环境中保持随机设计存在问题,但也有一些迹象表明在污名化、心理健康和 PrEP 方面出现了积极的转变。
{"title":"Reducing stigma and promoting HIV wellness/mental health of sexual and gender minorities: RCT results from a group-based programme in Nigeria","authors":"Julie Pulerwitz,&nbsp;Ann Gottert,&nbsp;Waimar Tun,&nbsp;Anita Fernandez Eromhonsele,&nbsp;Progress Lanre Oladimeji,&nbsp;Elizabeth Shoyemi,&nbsp;Mauton Akoro,&nbsp;Columbus Ndeloa,&nbsp;Adebola Adedimeji","doi":"10.1002/jia2.26256","DOIUrl":"https://doi.org/10.1002/jia2.26256","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Introduction&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;High levels of HIV stigma as well as stigma directed towards sexual and/or gender minorities (SGMs) are well documented in the African setting. These intersecting stigmas impede psychosocial wellbeing and HIV prevention and care. Yet, there are few if any evidence-based interventions that focus on reducing internalized stigma and promoting mental health and HIV wellness for SGMs in Africa. We developed and evaluated a group-based intervention drawing on cognitive behavioural therapy (CBT) strategies for men who have sex with men (MSM) and transgender women (TGW) at risk for or living with HIV in Lagos, Nigeria.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The intervention comprised four weekly in-person group sessions facilitated by community health workers. We conducted a delayed intervention group randomized controlled trial (April−September 2022), with pre-post surveys plus 3-month follow-up (immediate group only), as well as qualitative research with participants and programme staff. Outcomes included internalized stigma related to SGM and HIV status, depression, resiliency/coping and pre-exposure prophylaxis (PrEP)/HIV treatment use.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Mean age of the 240 participants was 26 years (range 18−42). Seventy-seven percent self-identified as MSM and 23% TGW; 27% were people with HIV. Most (88%) participants attended all four sessions, and 98% expressed high intervention satisfaction. There was significant pre-post improvement in each psychosocial outcome, in both the immediate and delayed arms. There were further positive changes for the immediate intervention group by 3-month follow-up (e.g. in intersectional internalized stigma, depression). While baseline levels of ever-PrEP use were the same, 75% of immediate-group participants reported currently using PrEP at 3 months post-intervention versus 53% of delayed-group participants right after the intervention (&lt;i&gt;p&lt;/i&gt;&lt;0.01). Participants post-intervention described (in qualitative interviews) less self-blame, and enhanced social support and resilience when facing stigma, as well as motivation to use PrEP, and indicated that positive pre-intervention changes in psychosocial factors found in the delayed group mainly reflected perceived support from the study interviewers.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusions&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;This study demonstrated the feasibility and acceptability of a group-based CBT model for MSM and TGW in Nigeria. There were also some indications of positive shifts related to stigma, mental hea","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"27 6","pages":""},"PeriodicalIF":6.0,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26256","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141251457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cost-Effectiveness and Budget Impact Analysis of the Implementation of Differentiated Service Delivery Models for HIV Treatment in Mozambique: a Modelling Study 在莫桑比克实施艾滋病毒治疗差异化服务提供模式的成本效益和预算影响分析:模型研究。
IF 6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-05-27 DOI: 10.1002/jia2.26275
Dorlim Antonio Moiana Uetela, Marita Zimmermann, Sérgio Chicumbe, Eduardo Samo Gudo, Ruanne Barnabas, Onei Andre Uetela, Aneth Dinis, Orvalho Augusto, Sandra Gaveta, Aleny Couto, Irénio Gaspar, Hélder Macul, James P. Hughes, Sarah Gimbel, Kenneth Sherr
<div> <section> <h3> Introduction</h3> <p>In 2018, the Mozambique Ministry of Health launched guidelines for implementing differentiated service delivery models (DSDMs) to optimize HIV service delivery, improve retention in care, and ultimately reduce HIV-associated mortality. The models were fast-track, 3-month antiretrovirals dispensing, community antiretroviral therapy groups, adherence clubs, family approach and three one-stop shop models: adolescent-friendly health services, maternal and child health, and tuberculosis. We conducted a cost-effectiveness analysis and budget impact analysis to compare these models to conventional services.</p> </section> <section> <h3> Methods</h3> <p>We constructed a decision tree model based on the percentage of enrolment in each model and the probability of the outcome (12-month retention in treatment) for each year of the study period—three for the cost-effectiveness analysis (2019–2021) and three for the budget impact analysis (2022–2024). Costs for these analyses were primarily estimated per client-year from the health system perspective. A secondary cost-effectiveness analysis was conducted from the societal perspective. Budget impact analysis costs included antiretrovirals, laboratory tests and service provision interactions. Cost-effectiveness analysis additionally included start-up, training and clients’ opportunity costs. Effectiveness was estimated using an uncontrolled interrupted time series analysis comparing the outcome before and after the implementation of the differentiated models. A one-way sensitivity analysis was conducted to identify drivers of uncertainty.</p> </section> <section> <h3> Results</h3> <p>After implementation of the DSDMs, there was a mean increase of 14.9 percentage points (95% CI: 12.2, 17.8) in 12-month retention, from 47.6% (95% CI, 44.9–50.2) to 62.5% (95% CI, 60.9–64.1). The mean cost difference comparing DSDMs and conventional care was US$ –6 million (173,391,277 vs. 179,461,668) and –32.5 million (394,705,618 vs. 433,232,289) from the health system and the societal perspective, respectively. Therefore, DSDMs dominated conventional care. Results were most sensitive to conventional care interaction costs in the one-way sensitivity analysis. For a population of 1.5 million, the base-case 3-year financial costs associated with the DSDMs was US$550 million, compared with US$564 million for conventional care.</p> </section> <section> <h3> Conclusions</h3> <p>DSDMs were less expensive and more effective in retaining clients 12 months after antiretroviral therapy initiation and were es
导言:2018 年,莫桑比克卫生部推出了实施差异化服务提供模式(DSDMs)的指导方针,以优化艾滋病服务提供,改善护理保留率,并最终降低艾滋病相关死亡率。这些模式包括快速通道、3 个月抗逆转录病毒药物配发、社区抗逆转录病毒治疗小组、依从性俱乐部、家庭方法和三种一站式服务模式:青少年友好型医疗服务、妇幼保健和结核病。我们对这些模式与传统服务进行了成本效益分析和预算影响分析:我们根据每种模式的注册比例和研究期间每年的结果概率(12 个月的保留治疗)构建了一个决策树模型--成本效益分析(2019-2021 年)和预算影响分析(2022-2024 年)分别为 3 年。这些分析的成本主要是从医疗系统的角度对每名患者每年的成本进行估算。从社会角度进行了二次成本效益分析。预算影响分析的成本包括抗逆转录病毒药物、实验室检测和服务提供互动。成本效益分析还包括启动、培训和客户机会成本。效果估算采用不受控制的间断时间序列分析法,对实施差异化模式前后的结果进行比较。进行了单向敏感性分析,以确定不确定性的驱动因素:实施 DSDM 后,12 个月的保留率平均提高了 14.9 个百分点(95% CI:12.2,17.8),从 47.6%(95% CI:44.9-50.2)提高到 62.5%(95% CI:60.9-64.1)。从卫生系统和社会角度来看,DSDM 与传统治疗的平均成本差异分别为-600 万美元(173,391,277 对 179,461,668 美元)和-3,250 万美元(394,705,618 对 433,232,289 美元)。因此,DSDMs 在常规护理中占主导地位。在单向敏感性分析中,结果对常规护理交互成本最为敏感。在150万人口中,与DSDM相关的基础3年财务成本为5.5亿美元,而传统医疗成本为5.64亿美元:结论:在开始抗逆转录病毒治疗 12 个月后,DSDM 在留住患者方面成本更低,效果更好,估计从 2022 年到 2024 年可为卫生系统节省约 1400 万美元。
{"title":"Cost-Effectiveness and Budget Impact Analysis of the Implementation of Differentiated Service Delivery Models for HIV Treatment in Mozambique: a Modelling Study","authors":"Dorlim Antonio Moiana Uetela,&nbsp;Marita Zimmermann,&nbsp;Sérgio Chicumbe,&nbsp;Eduardo Samo Gudo,&nbsp;Ruanne Barnabas,&nbsp;Onei Andre Uetela,&nbsp;Aneth Dinis,&nbsp;Orvalho Augusto,&nbsp;Sandra Gaveta,&nbsp;Aleny Couto,&nbsp;Irénio Gaspar,&nbsp;Hélder Macul,&nbsp;James P. Hughes,&nbsp;Sarah Gimbel,&nbsp;Kenneth Sherr","doi":"10.1002/jia2.26275","DOIUrl":"10.1002/jia2.26275","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Introduction&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;In 2018, the Mozambique Ministry of Health launched guidelines for implementing differentiated service delivery models (DSDMs) to optimize HIV service delivery, improve retention in care, and ultimately reduce HIV-associated mortality. The models were fast-track, 3-month antiretrovirals dispensing, community antiretroviral therapy groups, adherence clubs, family approach and three one-stop shop models: adolescent-friendly health services, maternal and child health, and tuberculosis. We conducted a cost-effectiveness analysis and budget impact analysis to compare these models to conventional services.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;We constructed a decision tree model based on the percentage of enrolment in each model and the probability of the outcome (12-month retention in treatment) for each year of the study period—three for the cost-effectiveness analysis (2019–2021) and three for the budget impact analysis (2022–2024). Costs for these analyses were primarily estimated per client-year from the health system perspective. A secondary cost-effectiveness analysis was conducted from the societal perspective. Budget impact analysis costs included antiretrovirals, laboratory tests and service provision interactions. Cost-effectiveness analysis additionally included start-up, training and clients’ opportunity costs. Effectiveness was estimated using an uncontrolled interrupted time series analysis comparing the outcome before and after the implementation of the differentiated models. A one-way sensitivity analysis was conducted to identify drivers of uncertainty.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;After implementation of the DSDMs, there was a mean increase of 14.9 percentage points (95% CI: 12.2, 17.8) in 12-month retention, from 47.6% (95% CI, 44.9–50.2) to 62.5% (95% CI, 60.9–64.1). The mean cost difference comparing DSDMs and conventional care was US$ –6 million (173,391,277 vs. 179,461,668) and –32.5 million (394,705,618 vs. 433,232,289) from the health system and the societal perspective, respectively. Therefore, DSDMs dominated conventional care. Results were most sensitive to conventional care interaction costs in the one-way sensitivity analysis. For a population of 1.5 million, the base-case 3-year financial costs associated with the DSDMs was US$550 million, compared with US$564 million for conventional care.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusions&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;DSDMs were less expensive and more effective in retaining clients 12 months after antiretroviral therapy initiation and were es","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"27 5","pages":""},"PeriodicalIF":6.0,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11129834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141156977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Lessons from the field: understanding the use of a youth tailored U = U tool by peer educators in Lesotho with adolescents and youth living with HIV 来自实地的经验:了解莱索托同伴教育者对青少年艾滋病毒感染者使用为青年量身定制的 U = U 工具的情况。
IF 6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-05-27 DOI: 10.1002/jia2.26267
Cosima Lenz, The Committee of African Youth Advisors, Thabelang Rabaholo, Matsepo Mphafi, Felleng Samonyane, Lauren Greenberg, Angelique Thomas, Elona Toska

Adolescence is defined by significant socio-emotional changes and vulnerability. Adolescents and youth living with HIV (AYLHIV) experience worse clinical HIV outcomes—adherence, retention and viral load suppression—compared to adults [1]. Novel approaches to implement evidence-based interventions to address their unique needs and life-stage are needed.

Undetectable = Untransmittable (U = U) is important in the comprehensive care of AYLHIV [2, 3]. U = U is a community-driven, evidence-based movement embodying the message that a person living with HIV who has reached and sustained an undetectable viral load (<200 copies/ml) will not transmit HIV to a sexual partner [4, 5]. As AYLHIV navigate friendships, sexual and romantic relationships, and parenthood, U = U may be a powerful tool for safe relationships and motivation for maintaining viral suppression [6]. Limited U = U interventions exist for AYLHIV, especially in Eastern and Southern Africa, where nearly 80% of AYLHIV reside.

The experience of implementing this tool reveals the practicality and promise of a narrative, youth-friendly graphic novel tool on a topic like U = U.

The authors declare no competing interests.

CL, TR, ET, AT, MM and CAYA conceptualized the project. Data tools were designed by CL, TR and MM with inputs from CAYA, ET and AT. Data collection was facilitated by TR and MM. Data analysis was led by CL. The draft was jointly constructed by all authors and reviewed by all authors.

ET/AT were funded by the Fogarty International Center, National Institute on Mental Health, National Institutes of Health [K43TW011434] and UKRI GCRF Accelerating Achievement for Africa's Adolescents (Accelerate) Hub (ES/S008101/1).

The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health.

青少年时期社会情感发生了重大变化,容易受到伤害。与成年人相比,青少年艾滋病病毒感染者(AYLHIV)的临床治疗效果更差,包括依从性、保留率和病毒载量抑制率[1]。需要采用新的方法来实施循证干预,以满足他们的独特需求和生命阶段。"检测不到 = 无法传播"(U = U)对青少年艾滋病病毒感染者的综合治疗非常重要 [2,3]。检测不到 = 无法传播(U = U)对于 AYLHIV 的全面护理非常重要[2,3]。U = U 是一项以社区为主导、以证据为基础的运动,它所传达的信息是:达到并维持检测不到病毒载量(200 拷贝/毫升)的 HIV 感染者不会将 HIV 传播给性伴侣[4,5]。当艾滋病病毒感染者在朋友关系、性关系、恋爱关系和为人父母的过程中不断摸索时,U = U 可能会成为促进安全关系和保持病毒抑制的有力工具[6]。针对 AYLHIV 的 U = U 干预措施非常有限,尤其是在东部和南部非洲,那里居住着近 80% 的 AYLHIV。CL、TR 和 MM 设计了数据工具,CAYA、ET 和 AT 提供了意见。TR 和 MM 协助收集数据。数据分析由 CL 领导。ET/AT得到了美国国立卫生研究院国家心理健康研究所福加蒂国际中心[K43TW011434]和英国皇家研究院GCRF加速非洲青少年成就(Accelerate)中心(ES/S008101/1)的资助。
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引用次数: 0
HPTN 083-02: factors influencing adherence to injectable PrEP and retention in an injectable PrEP study HPTN 083-02:影响坚持注射 PrEP 和坚持注射 PrEP 研究的因素。
IF 6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-05-23 DOI: 10.1002/jia2.26252
Christina Psaros, Georgia R. Goodman, Jasper S. Lee, Whitney Rice, Colleen F. Kelley, Temitope Oyedele, Lara E. Coelho, Nittaya Phanuphak, Yashna Singh, Keren Middelkoop, Sam Griffith, Marybeth McCauley, James Rooney, Alex R. Rinehart, Jesse Clark, Vivian Go, Jeremy Sugarman, Sheldon D. Fields, Adeola Adeyeye, Beatriz Grinsztejn, Raphael J. Landovitz, Steven A. Safren, the HPTN 083-02 Study Team
<div> <section> <h3> Introduction</h3> <p>HPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial.</p> </section> <section> <h3> Methods</h3> <p>Participants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (<i>N</i> = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (<i>n</i> = 27), non-adherent (<i>n =</i> 12) and early discontinuers (<i>n</i> = 1). Data were organized using NVivo software and analysed using content analysis.</p> </section> <section> <h3> Results</h3> <p>Participants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules).</p> </section> <section> <h3> Conclusions</h3> <p>Respondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility
前言HPTN 083 证明了长效卡博替拉韦(CAB-LA)与每日口服恩曲他滨/富马酸替诺福韦二吡呋酯(TDF/FTC)相比,作为暴露前预防药物(PrEP)在同性男性和变性男男性行为者(MSM/TGW)中的优越性。HPTN 083 为了解临床试验中使用注射 PrEP 的经验提供了首次机会:在 2019 年 11 月至 2020 年 3 月期间,有目的性地从两个美国研究机构(伊利诺伊州芝加哥市和佐治亚州亚特兰大市)和一个国际研究机构(巴西里约热内卢市)抽取参与者进行个人定性访谈(N = 40),以探讨试验经验、依从性障碍以及可能影响研究实施或结果的其他因素。由于疗效原因,盲法阶段提前结束;本分析包括在解除盲法之前进行的访谈,访谈对象为按依从性(即注射就诊率)定义的三组:依从者(n = 27)、非依从者(n = 12)和提前终止者(n = 1)。使用 NVivo 软件对数据进行整理,并使用内容分析法对数据进行分析:参与者(平均年龄:27 岁)主要是顺性别 MSM(90%)和黑人/非裔美国人(60%)。参加试验和使用 PrEP 的原因包括:在感染艾滋病病毒时更倾向于使用艾滋病病毒预防药物而不是治疗;能够通过与研究相关的教育和服务提高健康水平;能够免费获得新颖、方便的艾滋病病毒预防产品;以及通过研究为 MSM/TGW 社区做出贡献。参与者将与研究人员接触的积极体验与他们的日常临床护理进行了对比,并强调增加日程安排的灵活性、充分的沟通、不做判断的咨询以及开放、肯定的环境(如同情、减少污名化)是坚持治疗的促进因素。总体而言,注射体验是积极的;一些人描述了早期与注射有关的焦虑,但随着时间的推移和一定程度的控制(如注射前倒计时),这种焦虑有所缓解,注射部位的不适感也很小。有报告称,人们对注射式 PrEP 存在一些担忧和误解。在所有坚持治疗的类别中,阻碍坚持治疗的因素包括结构性因素(如经济限制、旅行)和相互竞争的需求(如工作时间安排):结论:受访者认为参与注射式 PrEP 试验是一种积极的体验,也是提高幸福感的一种手段。研究地点的灵活性和肯定性的诊所环境(包括非评判性咨询)是促进坚持注射的关键因素。为支持坚持注射,解决结构性障碍和推广灵活注射方式的干预措施可能最为有效。
{"title":"HPTN 083-02: factors influencing adherence to injectable PrEP and retention in an injectable PrEP study","authors":"Christina Psaros,&nbsp;Georgia R. Goodman,&nbsp;Jasper S. Lee,&nbsp;Whitney Rice,&nbsp;Colleen F. Kelley,&nbsp;Temitope Oyedele,&nbsp;Lara E. Coelho,&nbsp;Nittaya Phanuphak,&nbsp;Yashna Singh,&nbsp;Keren Middelkoop,&nbsp;Sam Griffith,&nbsp;Marybeth McCauley,&nbsp;James Rooney,&nbsp;Alex R. Rinehart,&nbsp;Jesse Clark,&nbsp;Vivian Go,&nbsp;Jeremy Sugarman,&nbsp;Sheldon D. Fields,&nbsp;Adeola Adeyeye,&nbsp;Beatriz Grinsztejn,&nbsp;Raphael J. Landovitz,&nbsp;Steven A. Safren,&nbsp;the HPTN 083-02 Study Team","doi":"10.1002/jia2.26252","DOIUrl":"10.1002/jia2.26252","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Introduction&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;HPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Participants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (&lt;i&gt;N&lt;/i&gt; = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (&lt;i&gt;n&lt;/i&gt; = 27), non-adherent (&lt;i&gt;n =&lt;/i&gt; 12) and early discontinuers (&lt;i&gt;n&lt;/i&gt; = 1). Data were organized using NVivo software and analysed using content analysis.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Participants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules).&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusions&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Respondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"27 5","pages":""},"PeriodicalIF":6.0,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26252","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141086341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The potential of broadly neutralizing antibodies for HIV prevention 广泛中和抗体预防艾滋病毒的潜力
IF 6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-05-17 DOI: 10.1002/jia2.26257
Huub C. Gelderblom, Lawrence Corey, Dan H. Barouch
<p>The number of new HIV acquisitions globally has declined, but not rapidly enough to meet the 2030 targets set by UNAIDS and the United Nations Sustainable Development Goals (SDGs) [<span>1, 2</span>]. Despite intense efforts such as those to support the UNAIDS 95-95-95 targets and to expand the availability of oral pre-exposure prophylaxis (PrEP), progress in primary prevention of HIV acquisition has lagged. There were 1.3 million new HIV acquisitions in 2022, and at current rates of decline, this number is projected to decrease to 900,000 new HIV acquisitions by 2030, which is far from the SDG target of 300,000. The number of people living with HIV will continue to increase from 39 million in 2022 to a projected 45 million in 2030 [<span>1-3</span>].</p><p>In this Viewpoint, we review the potential of HIV broadly neutralizing monoclonal antibodies (bnAbs) as a long-acting injectable immunoprophylaxis regimen to reduce HIV acquisition in high-risk populations. HIV bnAbs can recognize and neutralize a wide range of HIV strains, making them a promising tool for HIV prevention [<span>4</span>]. In the last 10−15 years, several HIV bnAbs have been isolated and have entered clinical development [<span>5</span>] (Table 1). These include antibodies against the CD4 binding site, the V3 glycan supersite and the V2 apex of the Env trimer. During the COVID-19 pandemic, monoclonal antibodies were delivered on an unprecedented scale for the prevention of SARS-CoV-2, showing the feasibility of using antibodies for prevention.</p><p>The proof-of-concept that an HIV bnAb can prevent HIV acquisition was demonstrated in 2021 by the Antibody Mediated Prevention (AMP) trials [<span>6</span>]. These two harmonized phase 2B clinical trials—one conducted in the United States and Latin America in men who have sex with men and transgender persons and the other conducted in sub-Saharan Africa in cisgender women—showed that the prototype HIV bnAb VRC01 could prevent HIV acquisition, but was only effective against sensitive virus (IC80 < 1 µg/ml). The determinant of efficacy was the susceptibility of the infecting HIV strain to the antibody. The trials also provided a target serum antibody titre as a correlate of protection [<span>7</span>]. For HIV bnAbs to achieve broad protection against circulating HIV strains, a combination of antibodies targeting multiple epitopes will be needed. Several groups have shown that a cocktail of three complementary bnAbs, such as a combination of antibodies targeting the CD4 binding site, V3 loop and V2 loop, provide broad neutralization coverage of global viruses in vitro, which supports the rationale for clinical evaluation of such bnAb cocktails [<span>8, 9</span>].</p><p>Next-generation HIV bnAbs have entered clinical trials [<span>5, 10</span>] (Table 1). These antibodies have been engineered to include mutations in the variable Fab region for greater potency and breadth, as well as mutations M428L/N434S or “LS” in the constant
要想取得成功,需要政府、制药公司、医疗服务提供者、社区和个人等社会各界齐心协力、通力合作,在全球范围内推广艾滋病 bnAbs。展望 2030 年以后,将创新的科学工具与公平获取政策相结合将是扭转艾滋病防治形势的关键。
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引用次数: 0
Breaking barriers: addressing transphobia and advancing transgender rights in the Asia-Pacific and beyond 打破障碍:在亚太地区及其他地区消除对变性人的仇视并促进变性人的权利。
IF 6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-05-16 DOI: 10.1002/jia2.26273
Rena Janamnuaysook, Danvic Rosadiño, Erika Castellanos
<p>The International Day against Homophobia and Transphobia annually memorializes the rights violations of transgender people, yet once a year will not be enough to remember the atrocities that transgender people have to face and endure every single day. Globally, perspectives on transphobia are shaped by cultural, legal and social contexts. In multiple countries, there is a growing recognition of transgender rights, with laws evolving to protect against discrimination and hate crimes [<span>1</span>]. However, transphobia remains pervasive, affecting access to healthcare, education, employment and social acceptance [<span>2</span>].</p><p>In the Asia-Pacific region, transgender people often face severe social stigma, legal penalties, and even violence, with little to no legal protection [<span>3</span>]. In some instances, colonial legacies have left enduring impacts on societal views towards gender diversity, further entrenching transphobia [<span>4</span>]. Transgender communities in the Philippines and Thailand have been historically struggling to battle for equality. In the Philippines, the “Equality Law” was first introduced in 2007, which is an anti-discrimination bill based on sexual orientation, gender identity, gender expression and sex characteristics (SOGIESC). Due to the ongoing failure to pass the law, it has since been repeatedly refiled. In Thailand, the “Gender Equality Act” was enacted by the national government in 2015, which broadly promoted gender equality. In addition, Thailand recently passed a same-sex marriage bill that the lower house of the Parliament approved by an overwhelming majority [<span>5</span>].</p><p>Although some Asian countries, like India, recognize transgender people as a separate gender for legal documents, many others do not, reflecting the institutionalized transphobia persisting across the region. This leaves individuals vulnerable to pervasive stigma and discrimination [<span>6</span>], fuelled by entrenched fears of identity falsification and deeply ingrained transphobic attitudes rooted in hetero-cis-normative beliefs [<span>7</span>]. Negative media representations further exacerbate these challenges, often linking transgender identities with stereotypical depictions of sex work and violence [<span>8</span>].</p><p>Notably, only 23 out of 193 United Nations member states legislated legal gender recognition based on self-identification [<span>9</span>]. Without legal gender recognition in many countries in Asia and the Pacific, transgender people find it challenging to access public services and healthcare, due to transphobic environments. This can include client intake forms with binary gender options, judgemental attitudes from healthcare providers and a lack of transgender-competent care services [<span>10</span>]. In the Philippines, the transgender community faces difficulties in accessing medical services in the country. Gender-affirming hormone therapy and surgery can only be accessed by tho
自 2024 年初以来,由于这些网络和媒体攻击,相关人员不得不提高其个人安全和安保标准,包括数字安全和管理额外的工作量。对相关人员造成的压力以及给他们工作的组织带来的负担,都是反性别运动的产物,他们竭力削弱我们的群体,阻碍世卫组织准则制定小组会议取得进展,最终推迟了这一急需的变性和性别多元化成人准则的发布。在纪录片《披露:银幕上的变性生活》中,杰米-克莱顿(Jamie Clayton)用一句话总结了变性群体如何在社会中定位自己:"正面代表越多,这个群体获得的自信就越多,这就会让我们处于更危险的境地"。代表性很重要,因为这有助于社会认识到这个群体的存在,但这种认识可能会让一些人感到威胁,从而导致报复行为--报复行为往往来自于对变性人群体的相对无知。对性别认同的法律承认是最重要的,这需要全面的立法,明确保障跨性别者的权利,包括基于自我认同的法律性别承认优先于国家认可的、通常是二元的跨性别认同。将跨性别医疗服务纳入医疗机构,并扩大性别确认医疗服务(如激素治疗和手术)的可及性,是确保公平提供医疗服务的必要步骤。此外,打击仇视变性者的努力必须解决交叉形式的歧视,包括种族主义、阶级歧视和能力歧视,认识到来自边缘化社区的变性者所面临的多重障碍。此外,教育和宣传活动对于挑战误解和减少围绕变性身份的污名化也是不可或缺的。这些举措应促进对性别多样性的同情、理解和接受,在教育机构、工作场所和社区营造包容性的环境。总之,打击对变性人的仇视需要全世界个人、社区和政府的集体行动和团结。通过挑战歧视性态度和政策、营造包容性环境、倡导法律和社会对变性人权利的承认,我们可以向往一个所有人都能自由、真实地生活而不必担心歧视或暴力的世界。DR 和 EC 声明不存在利益冲突。DR和EC审阅并提供意见。所有作者均批准了最终稿件。
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引用次数: 0
期刊
Journal of the International AIDS Society
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