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Adherence measurement considerations for oral antiretroviral medications 口服抗逆转录病毒药物的依从性测量注意事项。
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-26 DOI: 10.1002/jia2.26397
Corwin Coppinger, Peter L. Anderson
<p>Non-adherence has been, and remains, the most powerful predictor of unfavourable outcomes for both pre-exposure prophylaxis (PrEP) and anti-retroviral therapy. In particular, non-adherence during oral PrEP trials complicated the picture of efficacy, a fact that is again on display following the PURPOSE-1 trial that included daily oral emtricitabine/tenofovir alafenamide (F-TAF) and emtricitabine/tenofovir disoproxil fumarate [<span>1</span>]. Adherence in early trials was initially measured via self-report, pill counts and medication dispensation records, all suggesting high adherence (>90%) during trial periods [<span>2, 3</span>]. However, analysis of biological samples from the active arms indicated much lower PrEP use (unquantifiable or low drug concentrations), and particularly low use among participants who seroconverted. The lessons learned from these trials include: objective adherence measures greatly outperformed indirect measures, and many participants, by virtue of repeated undetectable drug concentrations between study visits, likely had little intention of being adherent, and this was unbeknownst to study personnel. Intentionality of non-adherence is difficult to determine and nuanced and likely underappreciated when considering adherence measurements in trials.</p><p>In this Viewpoint, we highlight the need for more research to consider adherence measurements when participants have little intention of adhering to the medication. We recognize the only way to differentiate the intentionality of non-adherence is participant self-report, which is subject to social desirability bias [<span>4</span>]. We also recognize and acknowledge that open communication is critical to this subject and appreciate that the foundation of care requires open and non-judgemental conversations between clients and clinicians. The reasons for participating in trials are complex: for some clients, there may be an initial intent to take the medication, but subsequent side effects or perception of not being at risk anymore may temper their enthusiasm to continue to take the medication; both the incentives of trial participation (financial and access to healthcare) and/or social desirability bias (not wanting to disappoint the study staff) may lead to misreporting of non-adherence. Nevertheless, clinicians and researchers need reliable adherence measurements to properly interpret expected/observed therapeutic outcomes, whether the participant is intentionally or unintentionally non-adherent. Additionally, intent to adhere is important for policymakers who must target appropriate populations for medical interventions (i.e. those who intend to be adherent).</p><p>The main adherence assessment in the recently published PURPOSE-1 study was intraerythrocytic tenofovir-diphosphate (TFV-DP), the phosphorylated anabolite of TFV, which is formed and trapped in red blood cells with a 17-day half-life. It accumulates with repeated dosing (i.e. adherence) and provides
PURPOSE-1 研究报告了基于 DBS 中 TFV-DP 的细粒度依从性数据,以及 F-TAF 的依从性-疗效关系[1]。这些数据说明了 F-TAF 的生物学疗效,以及在这一人群中每日口服 PrEP 的可能性较低。已发表的许多出色的依从性综述讨论了 PrEP 时代其他依从性评估的优缺点,包括自我报告、宣布和不宣布的药片计数、电子日记、电子药盒、数字药片和尿液/血浆药物浓度[7-9]。所有这些方法都有其优势和局限性,其潜在作用取决于研究或临床环境(表 1)。我们希望强调两个需要更多研究的注意事项,它们与参与者无意坚持治疗时的不坚持治疗有关。第一点是要求参与者配合进行依从性评估,如电子药盒和数字药片。这些方法依赖参与者参与依从性评估--例如,参与者知道打开电子药盒或吃下数字药片会发出依从性信号。如果参与者故意不坚持服药,他们可能会拒绝参加依从性评估,从而威胁到评估的效用[4]。这就引出了一个问题:故意不坚持服药如何影响配合依从性测量的决定?第二个问题与操纵依从性评估有关,这方面有几个例子。白大衣服药(如上所述)就是一个例子,即参与者长期漏服药物,但在就诊前服用了一剂药物,在一些试验中观察到 25-30% 的 PrEP 参与者有这种情况[6, 15]。尿液和血浆药物浓度检测(短半衰期生物标志物)很容易受到这种操纵。另一种情况是改变自我报告和药片数量,这在早期的 PrEP 试验中经常出现[2]。例如,参与者可能会在就诊前倾倒药物,以显示自己坚持服药。这就引出了一个问题:我们认为,这些问题以及更全面地考虑有意不依从性的必要性对于未来的依从性测量研究非常重要。我们认为,故意不坚持治疗在上述 PrEP 试验中很常见,但真正的流行程度和临床影响还需要进一步研究。这些问题都很重要,因为只有通过强有力的依从性测量,才能确定适当的目标人群,并对药物的安全性和有效性进行准确评估,从而指导临床管理。
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引用次数: 0
Recent infection testing to inform HIV prevention responses and surveillance in a programme context: lessons from implementation within a nationally scaled female sex worker programme in Zimbabwe 最近的感染检测为计划背景下的艾滋病毒预防对策和监测提供了信息:从津巴布韦全国性女性性工作者计划的实施中汲取的经验教训。
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-26 DOI: 10.1002/jia2.26391
Harriet S. Jones, Fortunate Machingura, Leah Gaihai, Memory Makamba, Thomas Chanyowedza, Panganai Masvikeni, Edward Matsikire, Primrose Matambanadzo, Sithembile Musemburi, Phillip N. Chida, Jeffery Dirawo, Owen Mugurungi, Sarah Bourdin, Bernadette Hensen, Lucy Platt, Gary Murphy, James R. Hargreaves, Frances M. Cowan, Brian Rice

Introduction

In the context of key population HIV testing programmes, identifying new HIV acquisitions, tracking incidence, and responding with prevention and treatment interventions will be critical for achieving HIV epidemic control. Laboratory tests for recently acquired HIV used as part of a “recent infection testing algorithm” (RITA), offer a potential tool to support this work. We implemented a RITA for female sex workers (FSWs) in Zimbabwe to explore opportunities and programmatic benefits.

Methods

Between October 2021 and January 2023, recency testing was offered to FSWs attending the Centre for Sexual Health and HIV/AIDS Research (CeSHHAR) Zimbabwe's key populations programme. Dried blood spot (DBS) samples were taken at 86 clinic sites across 10 provinces and Laboratory LAg Avidity and viral load testing conducted. RITA results were analysed and linked to programme data to explore geographical differences and calculate HIV incidence. We describe concurrent efforts in HIV testing for social (social network testing [SNT]) and sexual (index case testing [ICT]) contacts of those testing HIV positive.

Results

Among 24,976 FSWs tested at programme sites, 9.5% (2363/24,976) were confirmed HIV positive. We enrolled 55.5% (1311/2363) of eligible HIV-positive FSWs to our study, of whom 11.7% (153/1311) were identified as having recently acquired HIV. It took a median of 37 days (IQR 20–67) for samples to be processed. Enrolment rates varied between provinces but the proportion of recently acquired HIV was similar (range: 18.4% to 4.0%). Overall HIV incidence was 3.4 (95% CI 2.7−4.0) per 100py. Where results could be linked to routinely collected data, we found no evidence of a difference in test-positivity between the ICT and SNT contacts of those with recently acquired compared to those with long-term HIV.

Conclusions

Implementation of a RITA was possible within a nationally scaled sex worker programme, and while challenging to implement, can provide an understanding of transmission dynamics and HIV incidence in this context. Sub-optimal recruitment and data linkage limited the interpretation of our findings and opportunities for strategic gains though focusing on HIV prevention efforts.

导言:在重点人群艾滋病毒检测计划中,确定新感染艾滋病毒的人群、跟踪发病率并采取预防和治疗干预措施,对于实现艾滋病毒疫情控制至关重要。作为 "近期感染检测算法"(RITA)一部分的近期感染 HIV 实验室检测是支持这项工作的潜在工具。我们在津巴布韦为女性性工作者(FSWs)实施了 RITA,以探索机会和项目效益:在 2021 年 10 月至 2023 年 1 月期间,我们为参加津巴布韦性健康与艾滋病研究中心(CeSHHAR)重点人群项目的女性性工作者提供了回顾性检测。在 10 个省的 86 个诊所采集了干血斑 (DBS) 样本,并进行了实验室 LAg 阳性和病毒载量检测。我们对 RITA 结果进行了分析,并将其与计划数据联系起来,以探索地域差异并计算 HIV 感染率。我们介绍了同时对 HIV 检测呈阳性者的社会接触者(社会网络检测 [SNT])和性接触者(指数病例检测 [ICT])进行 HIV 检测的情况:结果:在项目地点接受检测的 24 976 名女性外阴残割者中,9.5%(2363/24 976)被确诊为 HIV 阳性。我们将 55.5%(1311/2363)符合条件的 HIV 阳性女性外阴残割者纳入研究,其中 11.7%(153/1311)被确认为最近感染了 HIV。样本处理时间的中位数为 37 天(IQR 20-67)。各省的登记率不同,但近期感染 HIV 的比例相似(范围:18.4% 至 4.0%)。总的 HIV 感染率为每 100 人 3.4 例(95% CI 2.7-4.0)。在结果可与常规收集数据联系起来的情况下,我们没有发现证据表明,与长期感染艾滋病病毒者相比,新近感染艾滋病病毒者的 ICT 接触者和 SNT 接触者的检测阳性率存在差异:在一项全国性的性工作者计划中实施 RITA 是可行的,虽然实施起来具有挑战性,但它可以帮助我们了解传播动态和艾滋病的发病率。招募和数据链接不够理想限制了我们对研究结果的解释,也限制了通过集中开展艾滋病预防工作而取得战略成果的机会。
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引用次数: 0
Preferences of people living with HIV for features of tuberculosis preventive treatment regimens in Uganda: a discrete choice experiment 乌干达艾滋病毒感染者对结核病预防治疗方案特点的偏好:离散选择实验。
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-26 DOI: 10.1002/jia2.26390
Hélène E. Aschmann, Allan Musinguzi, Jillian L. Kadota, Catherine Namale, Juliet Kakeeto, Jane Nakimuli, Lydia Akello, Fred Welishe, Anne Nakitende, Christopher Berger, David W. Dowdy, Adithya Cattamanchi, Fred C. Semitala, Andrew D. Kerkhoff

Introduction

Tuberculosis (TB) preventive treatment (TPT) is recommended for people living with HIV (PLHIV) in high TB burden settings. While 6 months of daily isoniazid remains widely used, shorter regimens are now available. However, little is known about preferences of PLHIV for key features of TPT regimens.

Methods

From July to November 2022, we conducted a discrete choice experiment among adult PLHIV engaged in care at an urban HIV clinic in Kampala, Uganda. Participants chose between two hypothetical TPT regimens with five different features (pills per dose, frequency, duration, need for adjusted antiretroviral therapy [ART] dosage and side effects), organized across nine random choice tasks. We analysed preferences using hierarchical Bayesian estimation, latent class analysis and willingness-to-trade simulations.

Results

Of 400 PLHIV, 392 (median age 44, 72% female, 91% TPT-experienced) had high-quality choice task responses. Pills per dose was the most important attribute (relative importance 32.4%, 95% confidence interval [CI] 31.6–33.2), followed by frequency (20.5% [95% CI 19.7–21.3]), duration (19.5% [95% CI 18.6–20.5]) and need for ART dosage adjustment (18.2% [95% CI 17.2–19.2]). Latent class analysis identified three preference groups: one prioritized less frequent, weekly dosing (N = 222; 57%); another was averse to ART dosage adjustment (N = 107; 27%); and the last prioritized short regimens with fewer side effects (N = 63; 16%). All groups highly valued fewer pills per dose. Overall, participants were willing to accept a regimen of 2.8 months’ additional duration [95% CI: 2.4–3.2] to reduce pills per dose from five to one, 3.6 [95% CI 2.4–4.8] months for weekly rather than daily dosing and 2.2 [95% CI 1.3–3.0] months to avoid ART dosage adjustment.

Conclusions

To align with preferences of PLHIV in Uganda, decision-makers should prioritize the development and implementation of TPT regimens with fewer pills, less frequent dosing and no need for ART dosage adjustment, rather than focus primarily on duration of treatment.

导言:在结核病高发地区,建议对艾滋病病毒感染者(PLHIV)进行结核病预防治疗(TPT)。虽然 6 个月的每日异烟肼治疗仍在广泛使用,但现在已有了更短的治疗方案。然而,人们对艾滋病病毒感染者对 TPT 方案关键特征的偏好知之甚少:2022 年 7 月至 11 月,我们在乌干达坎帕拉一家城市 HIV 诊所对接受治疗的成年 PLHIV 进行了离散选择实验。参与者在两种假定的 TPT 方案中做出选择,这两种方案具有五种不同的特征(每次服药的药片数、服药频率、服药时间、调整抗逆转录病毒疗法剂量的必要性和副作用),共分为九个随机选择任务。我们采用分层贝叶斯估计法、潜类分析法和交易意愿模拟法对偏好进行了分析:在 400 名艾滋病毒感染者中,392 人(中位年龄 44 岁,72% 为女性,91% 有 TPT 经验)对选择任务做出了高质量的回答。每剂药片是最重要的属性(相对重要性为 32.4%,95% 置信区间 [CI] 为 31.6-33.2),其次是频率(20.5% [95% CI 19.7-21.3])、持续时间(19.5% [95% CI 18.6-20.5])和抗逆转录病毒疗法剂量调整需求(18.2% [95% CI 17.2-19.2])。潜类分析确定了三个偏好群体:一个偏好群体优先考虑减少给药次数、每周给药(N = 222;57%);另一个偏好群体厌恶调整抗逆转录病毒疗法剂量(N = 107;27%);最后一个偏好群体优先考虑副作用较少的短期疗法(N = 63;16%)。所有群体都高度重视每次服药的药片数量减少。总体而言,参与者愿意接受增加 2.8 个月的疗程[95% CI:2.4-3.2]以将每次服药的剂量从 5 粒减少到 1 粒,愿意接受每周服药而不是每天服药的疗程为 3.6 个月[95% CI:2.4-4.8],愿意接受避免调整抗逆转录病毒疗法剂量的疗程为 2.2 个月[95% CI:1.3-3.0]:为了与乌干达 PLHIV 的偏好保持一致,决策者应优先考虑开发和实施药片数量更少、服药频率更低、无需调整抗逆转录病毒疗法剂量的 TPT 方案,而不是主要关注治疗持续时间。
{"title":"Preferences of people living with HIV for features of tuberculosis preventive treatment regimens in Uganda: a discrete choice experiment","authors":"Hélène E. Aschmann,&nbsp;Allan Musinguzi,&nbsp;Jillian L. Kadota,&nbsp;Catherine Namale,&nbsp;Juliet Kakeeto,&nbsp;Jane Nakimuli,&nbsp;Lydia Akello,&nbsp;Fred Welishe,&nbsp;Anne Nakitende,&nbsp;Christopher Berger,&nbsp;David W. Dowdy,&nbsp;Adithya Cattamanchi,&nbsp;Fred C. Semitala,&nbsp;Andrew D. Kerkhoff","doi":"10.1002/jia2.26390","DOIUrl":"10.1002/jia2.26390","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Tuberculosis (TB) preventive treatment (TPT) is recommended for people living with HIV (PLHIV) in high TB burden settings. While 6 months of daily isoniazid remains widely used, shorter regimens are now available. However, little is known about preferences of PLHIV for key features of TPT regimens.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>From July to November 2022, we conducted a discrete choice experiment among adult PLHIV engaged in care at an urban HIV clinic in Kampala, Uganda. Participants chose between two hypothetical TPT regimens with five different features (pills per dose, frequency, duration, need for adjusted antiretroviral therapy [ART] dosage and side effects), organized across nine random choice tasks. We analysed preferences using hierarchical Bayesian estimation, latent class analysis and willingness-to-trade simulations.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 400 PLHIV, 392 (median age 44, 72% female, 91% TPT-experienced) had high-quality choice task responses. Pills per dose was the most important attribute (relative importance 32.4%, 95% confidence interval [CI] 31.6–33.2), followed by frequency (20.5% [95% CI 19.7–21.3]), duration (19.5% [95% CI 18.6–20.5]) and need for ART dosage adjustment (18.2% [95% CI 17.2–19.2]). Latent class analysis identified three preference groups: one prioritized less frequent, weekly dosing (<i>N</i> = 222; 57%); another was averse to ART dosage adjustment (<i>N</i> = 107; 27%); and the last prioritized short regimens with fewer side effects (<i>N</i> = 63; 16%). All groups highly valued fewer pills per dose. Overall, participants were willing to accept a regimen of 2.8 months’ additional duration [95% CI: 2.4–3.2] to reduce pills per dose from five to one, 3.6 [95% CI 2.4–4.8] months for weekly rather than daily dosing and 2.2 [95% CI 1.3–3.0] months to avoid ART dosage adjustment.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>To align with preferences of PLHIV in Uganda, decision-makers should prioritize the development and implementation of TPT regimens with fewer pills, less frequent dosing and no need for ART dosage adjustment, rather than focus primarily on duration of treatment.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"27 12","pages":""},"PeriodicalIF":4.6,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26390","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142714991","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
Increasing event-driven HIV pre-exposure prophylaxis use among gay, bisexual and other men who have sex with men in Australia: results from behavioural surveillance 2019–2023 澳大利亚男同性恋、双性恋和其他男男性行为者越来越多地使用事件驱动的艾滋病毒暴露前预防措施:2019-2023 年行为监测结果
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-24 DOI: 10.1002/jia2.26398
Curtis Chan, Martin Holt, Anthony K. J. Smith, Timothy R. Broady, James MacGibbon, Limin Mao, Ben Wilcock, John Rule, Benjamin R. Bavinton
<div> <section> <h3> Introduction</h3> <p>HIV pre-exposure prophylaxis (PrEP) has been publicly available since 2018 in Australia as a daily regimen. In 2019, clinical guidelines were updated to support guidance on event-driven PrEP (ED-PrEP) use. We assessed trends in the PrEP dosing regimen by comparing daily PrEP use to ED-PrEP among cisgender gay, bisexual and other men who have sex with men (GBMSM).</p> </section> <section> <h3> Methods</h3> <p>Data from repeated, cross-sectional, national behavioural surveillance surveys were analysed from 2019 to 2023 among participants not living with HIV. Logistic regression models were conducted to assess trends and compared ED-PrEP users to non-PrEP users and daily PrEP.</p> </section> <section> <h3> Results</h3> <p>Among 38,880 participants, overall PrEP use with any regimen increased from 27.6% in 2019 to 42.7% in 2023 (OR = 1.16, 95% CI = 1.15−1.18, <i>p</i> < 0.001). Among 12,922 participants who reported PrEP use in the last 6 months, the proportion reporting ED-PrEP use increased from 7.6% in 2019 to 27.8% in 2023 (OR = 1.41, 95% CI = 1.37−1.46, <i>p</i> < 0.001) with those who reported daily PrEP decreasing from 92.4% to 63.3% (OR = 0.64, 95% CI = 0.62−0.66, <i>p</i> < 0.001). In a cross-sectional sub-sample in 2022–2023 (<i>n</i> = 8840), compared to ED-PrEP users, non-PrEP users were less likely to have received three or more HIV tests in the last 12 months (aRRR = 0.26, 95% CI = 0.22−0.31, <i>p</i> < 0.001), have 2−10 male sexual partners in the last 6 months (aRRR = 0.24, 95% CI = 0.14−0.41, <i>p</i> < 0.001) or 11 or more (aRRR = 0.26, 95% CI = 0.15−0.45, <i>p</i> < 0.001) compared to none, or to report condomless anal intercourse with casual partners (aRRR = 0.38, 95% CI = 0.32−0.46, <i>p</i> < 0.001). Compared to ED-PrEP users, daily PrEP users were more likely to have received three of more HIV tests in the last year (aRRR = 3.73, 95% CI = 3.15−4.40, <i>p</i> < 0.001) and less likely to be born overseas and lived in Australia for less than 5 years compared to being born in Australia (aRRR = 0.64, 95% CI = 0.49−0.83, <i>p</i> = 0.001).</p> </section> <section> <h3> Conclusions</h3> <p>While daily PrEP remains the most common PrEP dosing regimen among GBMSM in Australia, there has been a steep increase in the proportion of PrEP users who are taking ED-PrEP. Monitoring of PrEP use should continue to adapt to new dosing methods and future PrEP options. As ED-PrEP use increases, further work is needed to ensure those taking ED-PrEP are taking it effectively to prevent HI
引言 艾滋病暴露前预防疗法(PrEP)自 2018 年起在澳大利亚作为一种日常疗法公开上市。2019 年,临床指南进行了更新,以支持事件驱动的 PrEP(ED-PrEP)使用指南。我们通过比较男同性恋、双性恋和其他男男性行为者(GBMSM)中每日PrEP与ED-PrEP的使用情况,评估了PrEP剂量方案的趋势。 方法 分析了 2019 年至 2023 年期间在非 HIV 感染者中重复进行的横断面全国行为监测调查数据。采用逻辑回归模型评估趋势,并将 ED-PrEP 使用者与非 PrEP 使用者和每日 PrEP 使用者进行比较。 结果 在 38880 名参与者中,使用任何治疗方案的 PrEP 使用者总体比例从 2019 年的 27.6% 上升至 2023 年的 42.7%(OR = 1.16,95% CI = 1.15-1.18,p <0.001)。在报告在过去 6 个月中使用 PrEP 的 12922 名参与者中,报告使用 ED-PrEP 的比例从 2019 年的 7.6% 增加到 2023 年的 27.8%(OR = 1.41,95% CI = 1.37-1.46,p < 0.001),报告每天使用 PrEP 的参与者从 92.4% 下降到 63.3%(OR = 0.64,95% CI = 0.62-0.66,p < 0.001)。在 2022-2023 年的横断面子样本(n = 8840)中,与 ED-PrEP 使用者相比,非 ED-PrEP 使用者在过去 12 个月中接受三次或三次以上 HIV 检测的可能性较低(aRRR = 0.26,95% CI = 0.22-0.31,p < 0.001),在过去 6 个月中有 2-10 个男性性伴侣的可能性较低(aRRR = 0.24,95% CI = 0.14-0.41,p <0.001)或 11 个或更多 (aRRR = 0.26,95% CI = 0.15-0.45,p <0.001),或报告与临时性伴侣进行无套肛交 (aRRR = 0.38,95% CI = 0.32-0.46,p <0.001)。与 ED-PrEP 使用者相比,每日 PrEP 使用者更有可能在过去一年中接受过三次或三次以上的 HIV 检测(aRRR = 3.73,95% CI = 3.15-4.40,p < 0.001),而且与在澳大利亚出生的人相比,在海外出生和在澳大利亚居住不到 5 年的人更不可能接受 HIV 检测(aRRR = 0.64,95% CI = 0.49-0.83,p = 0.001)。 结论 虽然在澳大利亚,每日服用 PrEP 仍是 GBMSM 最常见的 PrEP 服药方案,但服用 ED-PrEP 的 PrEP 使用者比例急剧上升。对 PrEP 使用情况的监测应继续适应新的给药方法和未来的 PrEP 选择。随着 ED-PrEP 使用的增加,需要进一步开展工作,以确保那些服用 ED-PrEP 的人能够有效地预防艾滋病毒。
{"title":"Increasing event-driven HIV pre-exposure prophylaxis use among gay, bisexual and other men who have sex with men in Australia: results from behavioural surveillance 2019–2023","authors":"Curtis Chan,&nbsp;Martin Holt,&nbsp;Anthony K. J. Smith,&nbsp;Timothy R. Broady,&nbsp;James MacGibbon,&nbsp;Limin Mao,&nbsp;Ben Wilcock,&nbsp;John Rule,&nbsp;Benjamin R. Bavinton","doi":"10.1002/jia2.26398","DOIUrl":"https://doi.org/10.1002/jia2.26398","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;HIV pre-exposure prophylaxis (PrEP) has been publicly available since 2018 in Australia as a daily regimen. In 2019, clinical guidelines were updated to support guidance on event-driven PrEP (ED-PrEP) use. We assessed trends in the PrEP dosing regimen by comparing daily PrEP use to ED-PrEP among cisgender gay, bisexual and other men who have sex with men (GBMSM).&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;Data from repeated, cross-sectional, national behavioural surveillance surveys were analysed from 2019 to 2023 among participants not living with HIV. Logistic regression models were conducted to assess trends and compared ED-PrEP users to non-PrEP users and daily PrEP.&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;Among 38,880 participants, overall PrEP use with any regimen increased from 27.6% in 2019 to 42.7% in 2023 (OR = 1.16, 95% CI = 1.15−1.18, &lt;i&gt;p&lt;/i&gt; &lt; 0.001). Among 12,922 participants who reported PrEP use in the last 6 months, the proportion reporting ED-PrEP use increased from 7.6% in 2019 to 27.8% in 2023 (OR = 1.41, 95% CI = 1.37−1.46, &lt;i&gt;p&lt;/i&gt; &lt; 0.001) with those who reported daily PrEP decreasing from 92.4% to 63.3% (OR = 0.64, 95% CI = 0.62−0.66, &lt;i&gt;p&lt;/i&gt; &lt; 0.001). In a cross-sectional sub-sample in 2022–2023 (&lt;i&gt;n&lt;/i&gt; = 8840), compared to ED-PrEP users, non-PrEP users were less likely to have received three or more HIV tests in the last 12 months (aRRR = 0.26, 95% CI = 0.22−0.31, &lt;i&gt;p&lt;/i&gt; &lt; 0.001), have 2−10 male sexual partners in the last 6 months (aRRR = 0.24, 95% CI = 0.14−0.41, &lt;i&gt;p&lt;/i&gt; &lt; 0.001) or 11 or more (aRRR = 0.26, 95% CI = 0.15−0.45, &lt;i&gt;p&lt;/i&gt; &lt; 0.001) compared to none, or to report condomless anal intercourse with casual partners (aRRR = 0.38, 95% CI = 0.32−0.46, &lt;i&gt;p&lt;/i&gt; &lt; 0.001). Compared to ED-PrEP users, daily PrEP users were more likely to have received three of more HIV tests in the last year (aRRR = 3.73, 95% CI = 3.15−4.40, &lt;i&gt;p&lt;/i&gt; &lt; 0.001) and less likely to be born overseas and lived in Australia for less than 5 years compared to being born in Australia (aRRR = 0.64, 95% CI = 0.49−0.83, &lt;i&gt;p&lt;/i&gt; = 0.001).&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;While daily PrEP remains the most common PrEP dosing regimen among GBMSM in Australia, there has been a steep increase in the proportion of PrEP users who are taking ED-PrEP. Monitoring of PrEP use should continue to adapt to new dosing methods and future PrEP options. As ED-PrEP use increases, further work is needed to ensure those taking ED-PrEP are taking it effectively to prevent HI","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"27 11","pages":""},"PeriodicalIF":4.6,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26398","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142707987","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
Updated guidelines on HIV post-exposure prophylaxis: continued efforts towards increased accessibility 最新的艾滋病毒暴露后预防指南:继续努力提高可及性。
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-22 DOI: 10.1002/jia2.26393
Lao-Tzu Allan-Blitz, Kenneth H. Mayer

Introduction

HIV transmission is ongoing in both high- and low-resource settings. Post-exposure prophylaxis (PEP) remains an important tool in preventing HIV; however, PEP is significantly underutilized. The multitude of barriers to PEP implementation include low patient and provider awareness and acceptability, limited access to treatment and prevention services, and high rates of stigma. The World Health Organization (WHO) recently released updated guidance on the delivery of HIV PEP. This commentary aims to highlight the salient changes, evaluate how such recommendations can overcome the existing barriers to PEP implementation and discuss strategies needed to put the updated guidance into practice.

Discussion

The 2024 WHO PEP guidelines continue a trend towards increasing access to PEP. Most notably, the WHO now provides strong recommendations that: (1) PEP be delivered in community settings (e.g. pharmacies, police stations and online platforms), and (2) PEP delivery and monitoring be done via task sharing involving non-specialist health workers (e.g. pharmacists or community health workers). The guidelines also emphasize that the PEP encounter is an important educable moment whereby a transition to pre-exposure prophylaxis among individuals at continued risk for HIV infection should be discussed. The decentralization of PEP delivery has the potential to overcome numerous barriers to PEP implementation, reduce time to initiation and support adherence with the 28-day course. To translate the recommendations into delivery programmes, however, much more work is needed. Detailed templates can help overcome the heterogeneity of both the community settings in which PEP can now be provided and the populations (e.g. survivors of sexual assault, healthcare workers, sex workers, etc.) among whom PEP may be indicated. Training of the workforce will be essential, which should include, as emphasized by the WHO, training in trauma-based care. Novel formulations of and delivery mechanisms for PEP are also emerging, and how such iterations can synergize with decentralized PEP delivery programmes remains to be seen.

Conclusions

The updated WHO PEP guidelines make major strides towards increasing access to PEP. Realization of such aims will require ongoing evaluation and support given the heterogeneity in who benefits most from PEP.

导言:在资源丰富和资源贫乏的环境中,艾滋病毒的传播都在持续。暴露后预防 (PEP) 仍是预防 HIV 的重要工具;然而,PEP 的使用率却严重不足。实施 PEP 所面临的众多障碍包括:患者和医疗服务提供者对 PEP 的认知度和接受度较低、获得治疗和预防服务的途径有限,以及污名率较高。世界卫生组织(WHO)最近发布了关于提供 HIV PEP 的最新指南。本评论旨在强调其中的突出变化,评估这些建议如何能够克服实施 PEP 的现有障碍,并讨论将最新指南付诸实践所需的策略:2024 年世卫组织 PEP 指南延续了增加 PEP 普及率的趋势。最值得注意的是,世卫组织现在强烈建议(1) 在社区环境(如药房、警察局和在线平台)中提供 PEP,以及 (2) 通过非专业卫生工作者(如药剂师或社区卫生工作者)分担任务的方式提供和监测 PEP。该指南还强调,PEP 是一个重要的教育时机,应在此讨论在有持续感染艾滋病毒风险的人群中过渡到暴露前预防的问题。分散提供 PEP 有可能克服实施 PEP 的诸多障碍,缩短启动时间并支持坚持 28 天的疗程。然而,要将这些建议转化为实施计划,还需要做更多的工作。详细的模板可以帮助克服现在可以提供 PEP 的社区环境和可能需要 PEP 的人群(如性侵犯幸存者、医护人员、性工作者等)的多样性。对医务人员进行培训至关重要,其中应包括世界卫生组织强调的创伤护理培训。PEP 的新配方和给药机制也在不断涌现,这些新配方和给药机制如何与分散的 PEP 给药计划协同增效仍有待观察:最新的世界卫生组织 PEP 指南在增加 PEP 普及率方面取得了重大进展。鉴于从 PEP 中获益最多的人群存在差异,实现这些目标将需要持续的评估和支持。
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引用次数: 0
The ground has shifted under PEPFAR: what does that mean for its future? PEPFAR 的基础已经发生变化:这对其未来意味着什么?
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-22 DOI: 10.1002/jia2.26396
Jennifer Kates, Brian Honermann, Gregorio Millett
<p>PEPFAR, the U.S. global HIV programme, has been credited with saving 25 million lives and changing the trajectory of the HIV/AIDS pandemic [<span>1</span>]. Last year, more than 20 million people were on antiretroviral therapy with support from PEPFAR, almost 2 million were newly enrolled on pre-exposure prophylaxis and 327,000 healthcare workers were directly supported by the program. PEPFAR also estimates that more than 5 million babies have been born without HIV. In addition, studies have found that PEPFAR funding is significantly associated with several, positive, knock-on effects beyond HIV, including increases in the gross domestic product (GDP) per capita growth rate, educational retention and childhood vaccination rates [<span>2</span>].</p><p>Created in 2003 in the United States by a Republican President, with strong, bipartisan support in Congress at the time, PEPFAR has largely maintained that support across multiple administrations and congresses, often standing outside the political fray in Washington, DC. But the ground upon which PEPFAR sits has shifted in fundamental ways, perhaps most obviously manifest in the challenges it recently faced in securing a 5-year reauthorization [<span>3</span>]. These shifts are multifaceted and intertwined and, in most cases, not specific to PEPFAR or HIV, but taken together, suggest a “rethink” for PEPFAR's next phase. Here, we explore some of these shifts and the questions they pose going forward, questions that have become even more important given the outcome of the U.S. election; a second Trump administration and a changing balance in Congress likely mean, at a minimum, even greater scrutiny of the programme.</p><p>One of the greatest shifts is in the global economy. While recovering, it continues to experience the economic effects of the COVID-19 pandemic, with GDP growth remaining below historic averages. Fiscal space is further strained by high inflation and the ongoing costs of multiple wars and humanitarian assistance [<span>4</span>]. For donor governments, these fiscal strains present challenges for financing health and development needs, including for HIV, and many are shifting away [<span>5</span>]. For low- and middle-income countries, rising debt burden threatens their economic recovery, with many poorer now than before COVID-19 [<span>4</span>].</p><p>More broadly, reports have found that the human rights environment in many countries is deteriorating, with negative effects on health [<span>6</span>]. This has particular implications for HIV given that many of the populations most affected—men who have sex with men, transgender women, people who use drugs and other marginalized groups—already face human rights barriers that put them at increased risk for HIV and complicate the ability to control HIV [<span>6</span>]. There is also evidence that civic space is closing in many localities, making it more difficult for civil society organizations to operate and organize and presenti
PEPFAR 是美国的一项全球艾滋病计划,它拯救了 2,500 万人的生命,改变了艾滋病毒/艾滋病的流行轨迹[1]。去年,2000 多万人在 PEPFAR 的支持下接受了抗逆转录病毒治疗,近 200 万人新接受了暴露前预防治疗,327,000 名医疗工作者直接得到了该计划的支持。据《总统艾滋病紧急救援计划》估计,500 多万婴儿在出生时没有感染艾滋病毒。此外,研究还发现,PEPFAR 的资金与 HIV 以外的几种积极的连锁反应有显著关联,包括人均国内生产总值 (GDP) 增长率、教育保留率和儿童疫苗接种率的提高 [2]。PEPFAR 于 2003 年由共和党总统在美国创立,当时在国会两党的大力支持下,PEPFAR 在多届政府和国会中基本保持了这种支持,经常置身于华盛顿特区的政治纷争之外。但是,PEPFAR 所处的环境已经发生了根本性的变化,最明显的表现可能就是它最近在获得五年期重新授权时所面临的挑战[3]。这些变化是多方面的、相互交织的,在大多数情况下,并不是 PEPFAR 或 HIV 所特有的,但综合在一起,就表明需要对 PEPFAR 的下一阶段进行 "重新思考"。在此,我们将探讨其中的一些转变及其对未来提出的问题,鉴于美国大选的结果,这些问题变得更加重要;特朗普的第二届政府和国会中不断变化的平衡可能至少意味着对该计划进行更严格的审查。全球经济虽然正在复苏,但仍受到 COVID-19 大流行病的经济影响,GDP 增长率仍低于历史平均水平。高通胀以及多场战争和人道主义援助的持续成本进一步压缩了财政空间[4]。对于捐助国政府来说,这些财政压力对资助健康和发展需求(包括艾滋病毒)构成了挑战,许多捐助国政府正在放弃资助[5]。对于中低收入国家来说,不断增加的债务负担威胁着它们的经济复苏,许多国家现在比 COVID-19 之前还要贫穷[4]。更广泛地说,报告发现许多国家的人权环境正在恶化,对健康产生了负面影响[6]。鉴于许多受影响最严重的人群--男男性行为者、变性妇女、吸毒者和其他边缘化群体--已经面临人权障碍,使他们感染艾滋病毒的风险增加,并使控制艾滋病毒的能力复杂化[6],这对艾滋病毒的影响尤为明显。还有证据表明,许多地方的公民空间正在关闭,使民间社会组织的运作和组织更加困难,并对艾滋病毒和其他健康需求提出了新的挑战[7]。例如,人们对科学和卫生机构的信任度下降,党派之间的分歧越来越大[8]。最后,近年来,全球卫生与发展领域变得更加复杂,越来越 "拥挤",出现了许多相互重叠的挑战,有时甚至是相互竞争的挑战。这包括目前的 "资金补充交通堵塞"[9],即多个机构同时要求捐助国政府提供资金。部分由于 PEPFAR 和全球抗击艾滋病、结核病和疟疾基金所取得的巨大成功,HIV 已不再像以前那样具有紧迫感,这使其筹资工作更具挑战性。事实上,许多捐助国政府已经减少了在艾滋病防治方面的支出,使得美国在艾滋病防治方面的负担越来越重[10]。即使是美国,它仍然是世界上最大的艾滋病捐助政府,其资助额在 2010 年达到了最高水位[11]。但疟疾和结核病等其他传染病的教训表明,当关注度和资金减少时,这些疾病又会死灰复燃[12]。这些更广泛的趋势对 PEPFAR 的支持及其正在进行的工作产生了影响,而 PEPFAR 创建时在任的美国国会议员人数越来越少,更加剧了这种影响。值此世界艾滋病日之际,这些问题和其他问题可能会为重新思考 PEPFAR 的未来提供新的机会,积极主动地重新塑造和重构 PEPFAR,同时继续关注终结艾滋病这一公共卫生威胁这一目标。鉴于美国总统选举的结果,这一点尤为重要。
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引用次数: 0
High retention among key populations initiated on HIV pre-exposure prophylaxis in Kigali City, Rwanda 卢旺达基加利市开始接受艾滋病毒暴露前预防治疗的重点人群中保留率较高。
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-20 DOI: 10.1002/jia2.26392
Athanase Munyaneza, Kiran Bhutada, Qiuhu Shi, Natalia Zotova, Etienne Nsereko, Benjamin Muhoza, Gallican Kubwimana, Gad Murenzi, Laetitia Nyirazinyoye, Kathryn Anastos, Viraj V. Patel, Jonathan Ross

Introduction

Key populations (KPs) including female sex workers (FSWs) and men who have sex with men (MSM) in sub-Saharan Africa are disproportionately impacted by HIV. Despite the increasing availability of pre-exposure prophylaxis (PrEP), data on retention remain limited. This study assessed PrEP retention at 1 and 12 months among Rwandan FSWs and MSM.

Methods

We analysed routine clinical data on adult FSWs and MSM receiving PrEP care from 11 health facilities in Kigali, Rwanda between 2019 and 2022. Retention was defined as attendance at regularly scheduled appointments for a PrEP refill. We used logistic regression to assess associations between demographic and clinical characteristics and retention at 1 and 12 months.

Results

Among 2043 PrEP initiators, 1343 (66%) were FSWs and 700 (34%) were MSM. FSWs reported a median number of eight sexual partners in the prior 7 days, 70% reported condomless sex and 94% considered themselves at high HIV risk. About 1239 (92%) and 1032 (77%) were retained at 1 and 12 months, respectively. One-month retention was lower among FSWs living with others (OR 0.59, 95% CI: 0.35−0.99; ref: living alone) or with low HIV risk perception (OR 0.12, 95% CI: 0.04−0.29). At 12 months, low HIV risk perception remained statistically significant (aOR 0.20, 95% CI: 0.12−0.32). At PrEP initiation, MSM reported a median of four sexual partners in the prior 12 months, 88% reported condomless sex and 72% considered themselves at high HIV risk. Retention rates were 96% at 1 month and 82% at 12 months. At 1 month, retention was higher among MSM with some education (OR 12.74, 95% CI: 2.74−70.93; ref: no education). At 12 months, retention was lower among MSM with part-time employment (aOR 0.29, 95% CI: 0.11, 0.76), students (aOR 0.12, 95% CI: 0.04, 0.37) and unemployed (aOR 0.12, 95% CI: 0.05, 0.28); ref: full-employed) and those unaware of PrEP at baseline (aOR 0.15, 95% CI: 0.10, 0.23).

Conclusions

We observed very high rates of PrEP retention among Rwandan FSWs and MSM. Predictors of retention included living situation, employment status, HIV risk perception and low PrEP awareness, but differed between FSWs and MSM. These findings suggest that targeted awareness campaigns tailored to different KPs could improve PrEP retention in care.

导言:撒哈拉以南非洲地区的关键人群(KPs),包括女性性工作者(FSWs)和男男性行为者(MSM),受到艾滋病毒的影响尤为严重。尽管暴露前预防疗法(PrEP)的可用性越来越高,但有关保留率的数据仍然有限。本研究评估了卢旺达家庭主妇和男男性行为者 1 个月和 12 个月的 PrEP 保持率:我们分析了 2019 年至 2022 年期间在卢旺达基加利 11 家医疗机构接受 PrEP 治疗的成年女性同性恋者和男男性行为者的常规临床数据。留用率的定义是定期赴约补服 PrEP 的出勤率。我们使用逻辑回归评估了人口统计学和临床特征与 1 个月和 12 个月的保留率之间的关系:在 2043 名 PrEP 启动者中,有 1343 人(66%)为女性社会工作者,700 人(34%)为男男性行为者。家庭主妇报告的前 7 天性伴侣数量中位数为 8 个,70% 的人报告了无安全套性行为,94% 的人认为自己处于 HIV 高危人群。分别有约 1239 人(92%)和 1032 人(77%)在 1 个月和 12 个月后继续接受治疗。与他人同居(OR 0.59,95% CI:0.35-0.99;参考:独居)或对 HIV 风险感知较低(OR 0.12,95% CI:0.04-0.29)的女性外阴残留者的 1 个月保留率较低。在 12 个月时,低 HIV 风险认知仍具有显著的统计学意义(aOR 0.20,95% CI:0.12-0.32)。在开始使用 PrEP 时,男男性行为者在过去 12 个月中报告的性伴侣中位数为 4 个,88% 的人报告了无安全套性行为,72% 的人认为自己处于 HIV 高风险状态。1 个月和 12 个月的保留率分别为 96% 和 82%。1 个月时,受过一定教育的 MSM 的保留率更高(OR 12.74,95% CI:2.74-70.93;参考:未受过教育)。12 个月时,有兼职工作(aOR 0.29,95% CI:0.11,0.76)、学生(aOR 0.12,95% CI:0.04,0.37)和失业(aOR 0.12,95% CI:0.05,0.28)的 MSM 以及基线时不知道 PrEP 的 MSM 的保留率较低(aOR 0.15,95% CI:0.10,0.23):我们观察到卢旺达女性同性恋者和男男性行为者中 PrEP 的保留率非常高。保留率的预测因素包括生活状况、就业状况、艾滋病风险认知和对 PrEP 的低认知度,但这在女性外阴残割者和男男性行为者之间存在差异。这些研究结果表明,针对不同的 KPs 开展有针对性的宣传活动可以提高 PrEP 在护理中的保留率。
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引用次数: 0
Learning from the first: a qualitative study of the psychosocial benefits and treatment burdens of long-acting cabotegravir/rilpivirine among early adopters in three U.S. clinics 向先行者学习:对美国三家诊所早期采用长效卡博特拉韦/利匹韦林的患者进行的心理社会效益和治疗负担定性研究。
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-20 DOI: 10.1002/jia2.26394
Katerina A. Christopoulos, Mollie B. Smith, Priyasha Pareek, Alicia Dawdani, Xavier A. Erguera, Kaylin V. Dance, Ryan S. Walker, Janet Grochowski, Francis Mayorga-Munoz, Matthew D. Hickey, Mallory O. Johnson, John Sauceda, Jose I. Gutierrez Jr., Elizabeth T. Montgomery, Jonathan A. Colasanti, Lauren F. Collins, Moira C. McNulty, Kimberly A. Koester
<div> <section> <h3> Introduction</h3> <p>Perspectives on long-acting injectable cabotegravir/rilpivirine (CAB/RPV-LA) from HIV health disparity populations are under-represented in current literature yet crucial to optimize delivery.</p> </section> <section> <h3> Methods</h3> <p>Between August 2022 and May 2023, we conducted in-depth interviews with people with HIV (PWH) at four HIV clinics in Atlanta, Chicago and San Francisco. Eligibility criteria were current CAB/RPV-LA use with receipt of ≥3 injections or CAB/RPV-LA discontinuation. We purposefully sampled for PWH who initiated with viraemia (plasma HIV RNA >50 copies/ml) due to adherence challenges, discontinuers, and cis and trans women. Interviews were coded and analysed using thematic methods grounded in descriptive phenomenology. Clinical data were abstracted from the medical record.</p> </section> <section> <h3> Results</h3> <p>The sample (San Francisco <i>n</i> = 25, Atlanta <i>n</i> = 20, Chicago <i>n</i> = 14 for total <i>n</i> = 59, median number of injections = 6) consisted of 48 PWH using CAB/RPV-LA and 11 who had discontinued. The median age was 50 (range 25–73) and 40 (68%) identified as racial/ethnic minorities, 19 (32%) cis or trans women, 16 (29%) were experiencing homelessness/unstable housing, 12 (20%) had recently used methamphetamine or opioids and 11 (19%) initiated with viraemia. All participants except one (who discontinued) had evidence of viral suppression at interview. Typical benefits of CAB/RPV-LA included increased convenience, privacy and freedom from being reminded of HIV and reduced anxiety about forgetting pills. However, PWH who became virally suppressed through CAB/RPV-LA use also experienced an amelioration of feelings of shame and negative self-worth related to oral adherence challenges. Regardless of baseline viral suppression status, successful use of CAB/RPV-LA amplified positive provider/clinic relationships, and CAB/RPV-LA was often viewed as less “work” than oral antiretroviral therapy, which created space to attend to other aspects of health and wellness. For some participants, CAB/RPV-LA remained “work,” particularly with regard to injection site pain and visit frequency. At times, these burdens outweighed the aforementioned benefits, resulting in discontinuation.</p> </section> <section> <h3> Conclusions</h3> <p>CAB/RPV-LA offers a range of logistical, psychosocial and care engagement benefits, which are experienced maximally by PWH initiating with viraemia due to adherence challenges; however, benefits do not always outweigh treatment burdens
导言:在目前的文献中,艾滋病毒健康差异人群对长效注射用卡博替拉韦/利匹韦林(CAB/RPV-LA)的看法所占比例较低,但这对优化治疗至关重要:方法:2022 年 8 月至 2023 年 5 月期间,我们在亚特兰大、芝加哥和旧金山的四家 HIV 诊所对 HIV 感染者(PWH)进行了深入访谈。资格标准为目前使用 CAB/RPV-LA,且注射次数≥3 次或已停止使用 CAB/RPV-LA。我们特意抽取了因坚持治疗而出现病毒血症(血浆 HIV RNA >50 copies/ml)的初诊感染者、停药者以及顺性和逆性女性。采用以描述性现象学为基础的主题方法对访谈进行编码和分析。临床数据摘自病历:样本(旧金山 n = 25,亚特兰大 n = 20,芝加哥 n = 14,总计 n = 59,注射次数中位数 = 6)包括 48 名使用 CAB/RPV-LA 的 PWH 和 11 名停止使用的 PWH。年龄中位数为 50 岁(25-73 岁不等),40 人(68%)为少数种族/民族,19 人(32%)为同性或异性女性,16 人(29%)无家可归/住房不稳定,12 人(20%)最近使用过甲基苯丙胺或阿片类药物,11 人(19%)开始时患有病毒血症。除一人(中断治疗)外,所有参与者在接受访谈时都有病毒抑制的证据。CAB/RPV-LA 的典型益处包括更方便、更私密、更免于被提醒感染艾滋病毒,以及减少对忘带药片的焦虑。然而,通过使用 CAB/RPV-LA 而获得病毒抑制的艾滋病感染者也体验到了与口服药物相关的羞耻感和负面自我价值感的改善。无论基线病毒抑制状态如何,成功使用 CAB/RPV-LA 都会扩大积极的医疗服务提供者/诊所关系,而且 CAB/RPV-LA 通常被视为比口服抗逆转录病毒疗法更少的 "工作",这就为关注健康和保健的其他方面创造了空间。对一些参与者来说,CAB/RPV-LA 仍然是 "工作",尤其是在注射部位疼痛和就诊频率方面。有时,这些负担超过了上述益处,从而导致中断:CAB/RPV-LA提供了一系列后勤、社会心理和护理参与方面的益处,由于依从性方面的挑战,感染病毒血症的PWH能够最大限度地体验到这些益处;然而,益处并不总是大于治疗负担,并可能导致中断治疗。我们关于坚持治疗与中断治疗的理由的研究结果可为患者的初次咨询和后续咨询提供参考。
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引用次数: 0
In-utero exposure to tenofovir-containing pre-exposure prophylaxis and bone mineral content in HIV-unexposed infants in South Africa 南非未接触艾滋病毒的婴儿在宫内接触含替诺福韦的暴露前预防药物和骨矿物质含量。
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-11 DOI: 10.1002/jia2.26379
Kerusha Reddy, Kimesh L. Naidoo, Carl Lombard, Zukiswa Godlwana, Alicia C. Desmond, Richard Clark, James F. Rooney, Glenda Gray, Dhayendre Moodley

Introduction

Tenofovir disoproxil fumarate (TDF) is a common drug of choice for pre-exposure prophylaxis (PrEP) or as a combination HIV treatment for pregnant women. In-utero exposure to TDF was found to be associated with lower bone mineral content (BMC) in HIV-exposed uninfected neonates. Data for infants born to women taking TDF-PrEP are lacking. The CAP016 randomized control trial was conducted in South Africa between September 2017 and August 2021 and pregnant women either initiated TDF/FTC PrEP in pregnancy (Immediate PrEP arm-IP) or at cessation of breastfeeding (Deferred PrEP arm-DP). In a secondary data analysis, we evaluated BMC in HIV-unexposed infants in the CAP016 trial in the first 18 months of life in association with maternal TDF-PrEP use during pregnancy.

Methods

Infants born to women randomized to the IP arm or DP arm in the CAP016 clinical trial had BMC measurements of the whole body with head (WBH) and lumbar spine (LS) by dual energy X-ray absorptiometry (DXA) at 6, 26, 50 and 74 weeks.

Results

Of 481 infants born to women enrolled in the CAP016 clinical trial, 335 (69.6%) infants had a minimum of one DXA scan of the WBH and LS between 6 and 74 weeks of age (168 IP and 167 DP). Women in the IP arm received TDF-FTC PreP for a median of 19 weeks between initiation in pregnancy and delivery. Using a mixed linear regression model and adjusted for gestational age, sex and ever-breastfed, the mean difference (95% CI) for BMC of the WBH between IP and DP arms were −0.74 (−8.69 to 7.20), −1.26 (−10.75 to 8.23), −9.17 (−20.02 to 1.69) and 5.02 (−6.74 to 16.78) g at 6, 26, 50 and 74 weeks (p = 0.283). Mean differences in BMC of the LS were 0.07 (−0.10 to 0.23), 0.02 (−0.18 to 0.22), −0.14 (−0.36 to 0.09) and 0.14 (−0.11 to 0.38) g at 6, 26, 50 and 74 weeks, respectively (p = 0.329).

Conclusions

In a randomized controlled trial, there were no differences in BMC of the WBH and LS between infants exposed to in-utero TDF-FTC PrEP and unexposed infants in the first 18 months of life.

简介:富马酸替诺福韦二吡呋酯(TDF)是暴露前预防(PrEP)或孕妇艾滋病综合治疗的常用药物。研究发现,宫内暴露于 TDF 与暴露于 HIV 的未感染新生儿骨矿物质含量(BMC)降低有关。目前尚缺乏服用 TDF-PrEP 的妇女所生婴儿的数据。CAP016 随机对照试验于 2017 年 9 月至 2021 年 8 月期间在南非进行,孕妇要么在怀孕期间开始服用 TDF/FTC PrEP(立即 PrEP 组-IP),要么在停止母乳喂养时开始服用 TDF/FTC PrEP(推迟 PrEP 组-DP)。在二次数据分析中,我们评估了 CAP016 试验中暴露于 HIV 的婴儿在出生后 18 个月内的 BMC 与母亲在孕期使用 TDF-PrEP 的关系:CAP016临床试验中被随机分配到IP组或DP组的妇女所生的婴儿在6周、26周、50周和74周时接受了双能X射线吸收测定法(DXA)对全身及头部(WBH)和腰椎(LS)的BMC测量:参加 CAP016 临床试验的妇女所生的 481 名婴儿中,有 335 名婴儿(69.6%)在 6 至 74 周龄期间至少接受过一次头颅和腰椎的 DXA 扫描(168 名 IP 婴儿和 167 名 DP 婴儿)。IP 组妇女从怀孕开始到分娩期间接受 TDF-FTC PreP 治疗的时间中位数为 19 周。使用混合线性回归模型并根据孕龄、性别和曾哺乳情况进行调整后,IP 和 DP 两组在 6、26、50 和 74 周时的 WBH BMC 平均差异(95% CI)分别为-0.74(-8.69 至 7.20)、-1.26(-10.75 至 8.23)、-9.17(-20.02 至 1.69)和 5.02(-6.74 至 16.78)克(p = 0.283)。在 6、26、50 和 74 周时,LS 的 BMC 平均差异分别为 0.07(-0.10 至 0.23)、0.02(-0.18 至 0.22)、-0.14(-0.36 至 0.09)和 0.14(-0.11 至 0.38)克(p = 0.329):在一项随机对照试验中,在出生后的前18个月中,接受过宫内TDF-FTC PrEP治疗的婴儿与未接受治疗的婴儿在WBH和LS的BMC方面没有差异。
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引用次数: 0
Patient and public involvement in HIV research: a mapping review and development of an online evidence map 患者和公众参与艾滋病研究:绘图审查和在线证据地图的开发。
IF 4.6 1区 医学 Q2 IMMUNOLOGY Pub Date : 2024-11-11 DOI: 10.1002/jia2.26385
David Jackson-Perry, Ellen Cart-Richter, David Haerry, Lindrit Ahmeti, Annatina Bieri, Alexandra Calmy, Marie Ballif, Chloé Pasin, Julia Notter, Alain Amstutz, the Swiss HIV Cohort Study Young Researchers’ Group, and the Swiss HIV Cohort Study
<div> <section> <h3> Introduction</h3> <p>Increasing evidence indicates the benefits of patient and public involvement (PPI) in medical research, and PPI is increasingly expected by funders and publishers. We conducted a mapping review of studies reporting examples of PPI implementation in HIV research, and developed an online evidence map to guide HIV researchers.</p> </section> <section> <h3> Methods</h3> <p>We systematically searched Medline and Embase up until 18 August 2024, including search terms with variations for PPI and HIV. We extracted information from identified studies in duplicate and analysed the data descriptively and qualitatively to describe types of PPI models and reported benefits, challenges, and mitigation strategies. This study was co-initiated and co-led by people living with HIV.</p> </section> <section> <h3> Results</h3> <p>We identified 17 studies reporting PPI in HIV research between 1992 and August 2024. Most PPI examples informed prospective clinical studies, but also qualitative research, questionnaire development, research priority setting and surveys. Ten studies described the number and characteristics of PPI members involved. We observed four PPI models, from a model that solely engaged PPI members for a specific task to a model whereby PPI representatives were integrated into the study team with decision-making authority. Benefits reported included wider dissemination of research results, better understanding of research material and results, and higher levels of trust and learning between researcher and communities. The most commonly reported challenges were the lack of specific resources for PPI, differing levels of knowledge and expertise, concern about HIV status disclosure, and lack of diversity of the PPI team. Uneven power dynamics, tensions, and differing expectations between stake-holder groups were also frequently noted.</p> </section> <section> <h3> Conclusions</h3> <p>This mapping review summarizes published examples of PPI in HIV research for various phases of research. There is a clear need to strengthen the reporting on PPI processes in HIV research, for example by following the Guidance for Reporting Involvement of Patients and the Public (GRIPP) 2 guidelines, and developing guidance on its hands-on implementation. We embedded PPI from study inception onwards, which potentially pre-empted some of the challenges reported in the reviewed examples. The resulting online evidence map is a starting point to guide researchers on integrating PPI into their own research.</p> </section>
导言:越来越多的证据表明,患者和公众参与(PPI)对医学研究大有裨益,资助者和出版商也越来越期待患者和公众参与。我们对报告在艾滋病研究中实施患者和公众参与(PPI)实例的研究进行了图谱审查,并开发了一份在线证据图谱,为艾滋病研究人员提供指导:我们对 Medline 和 Embase 进行了系统检索,检索期截至 2024 年 8 月 18 日,包括 PPI 和 HIV 的不同检索词。我们从确定的研究中提取了一式两份的信息,并对数据进行了描述性和定性分析,以描述PPI模式的类型以及报告的益处、挑战和缓解策略。本研究由艾滋病病毒感染者共同发起和领导:我们发现有 17 项研究报告了 1992 年至 2024 年 8 月期间艾滋病毒研究中的 PPI。大多数 PPI 实例都为前瞻性临床研究提供了信息,但也包括定性研究、问卷开发、研究优先级设定和调查。十项研究描述了参与其中的 PPI 成员的数量和特征。我们观察了四种公众参与模式,从仅让公众参与成员参与特定任务的模式,到将公众参与代表纳入研究团队并赋予其决策权的模式。据报告,这种模式的好处包括:研究成果得到了更广泛的传播,研究材料和成果得到了更好的理解,研究人员和社区之间的信任和学习水平得到了提高。最常报告的挑战是缺乏用于公众宣传的特定资源、知识和专业技能水平参差不齐、对艾滋病病毒感染状况披露的担忧以及公众宣传团队缺乏多样性。利益相关者群体之间不平衡的权力动态、紧张关系和不同的期望也经常被提及:本图谱审查总结了已发表的艾滋病毒研究中不同研究阶段的公众参与实例。显然,有必要加强对艾滋病研究中患者和公众参与过程的报告,例如遵循《患者和公众参与报告指南》(GRIPP)2 指南,并制定实际操作指南。我们从研究开始之初就将患者和公众参与纳入其中,这可能会预先避免已审查实例中报告的一些挑战。由此产生的在线证据地图是指导研究人员将 PPI 纳入自身研究的起点。
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Journal of the International AIDS Society
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