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A Systematic Review and Meta-analysis of the Impact of the COVID-19 Pandemic on Access to HIV Pre-exposure Prophylaxis: Lessons for Future Public Health Crises. COVID-19大流行对获取艾滋病暴露前预防措施的影响的系统回顾和元分析:未来公共卫生危机的教训》。
IF 2.9 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-11-01 Epub Date: 2024-10-07 DOI: 10.1097/QAI.0000000000003488
Luh Putu Lila Wulandari, Srila Nirmithya Salita Negara, Yusuf Ari Mashuri, Siska Dian Wahyuningtias, I Wayan Cahyadi Surya Distira Putra, Yanri W Subronto, Riris Andono Ahmad, Hasbullah Thabrany, Rebecca Guy, Matthew Law, Mohamed Hammoud, Benjamin B Bavinton, John Kaldor, Nicholas Medland, Marco Liverani, Ari Probandari, David Boettiger, Virginia Wiseman

Background: The World Health Organization is committed to strengthening access to pre-exposure prophylaxis (PrEP) for HIV prevention and its integration into primary care services. Unfortunately, the COVID-19 pandemic has disrupted the delivery of primary care, including HIV-related services. To determine the extent of this disruption, we conducted a systematic review and meta-analysis of the changes in access to PrEP services during the pandemic and the reasons for these changes.

Methods: A search was conducted using PubMed, Scopus, Embase, PsycINFO, and Cinahl for studies published between January 2020 and January 2023. Selected articles described self-reported disruptions to PrEP service access associated with the COVID-19 pandemic or its responses. Pooled effect sizes were computed using a random-effects model.

Results: Thirteen studies involving 12,652 PrEP users were included in our analysis. The proportion of participants reporting a disruption in access to PrEP services during the COVID-19 pandemic ranged from 3% to 56%, with a pooled proportion of 21% (95% confidence intervals: 8% to 38%). Social restrictions, financial constraints, and limited health insurance coverage were key factors affecting access to PrEP services during the pandemic.

Conclusions: To our knowledge, this is the first meta-analysis to quantify the extent of disruptions to accessing PrEP services because of the COVID-19 pandemic. To increase the ability of primary care services to maintain PrEP services during public health crises, a mixture of strategies is worth considering. These include multi-month PrEP prescriptions, telehealth services, deployment of peer support groups to provide a community-based service or home delivery, and provision of financial support interventions.

背景:世界卫生组织致力于加强接触前预防疗法(PrEP)在艾滋病预防中的应用,并将其纳入初级医疗服务。不幸的是,COVID-19 大流行扰乱了初级医疗服务的提供,包括与 HIV 相关的服务。为了确定这种干扰的程度,我们对大流行期间 PrEP 服务获取途径的变化及其原因进行了系统回顾和荟萃分析:我们使用 PubMed、Scopus、Embase、PsycINFO 和 Cinahl 对 2020 年 1 月至 2023 年 1 月间发表的研究进行了检索。所选文章描述了与 COVID-19 大流行或其应对措施相关的 PrEP 服务中断的自我报告。采用随机效应模型计算汇总效应大小:我们的分析包括 13 项研究,涉及 12,652 名 PrEP 用户。报告在 COVID-19 大流行期间 PrEP 服务中断的参与者比例从 3% 到 56% 不等,汇总比例为 21%(95% 置信区间:8% 到 38%)。在大流行期间,社会限制、经济制约和有限的医疗保险覆盖面是影响人们获得 PrEP 服务的关键因素:据我们所知,这是首次对 COVID-19 大流行对获得 PrEP 服务的干扰程度进行量化的荟萃分析。为了提高初级医疗服务机构在公共卫生危机期间维持 PrEP 服务的能力,值得考虑采取多种策略。这些策略包括多月 PrEP 处方、远程保健服务、部署同伴支持小组以提供社区服务或上门服务,以及提供财务支持干预措施。
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引用次数: 0
A Review and Economic Analysis of the Dapivirine Vaginal Ring as HIV Pre-Exposure Prophylaxis for Women, to Inform South African Public-Sector Guidelines. 对达匹韦林阴道环作为妇女艾滋病暴露前预防药物的审查和经济分析,为南非公共部门指导方针提供参考。
IF 2.9 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-11-01 Epub Date: 2024-10-07 DOI: 10.1097/QAI.0000000000003496
Trudy D Leong, Jeremy Nel, Lise Jamieson, Regina Osih, Halima Dawood, Hasina Subedar, Michael McCaul, Leigh F Johnson, Karen Cohen

Background: South Africa has a high HIV incidence and oral pre-exposure prophylaxis (PrEP) is available as public-sector standard of care. Access to alternative prevention methods for women may further reduce HIV acquisition.

Setting: South African public sector.

Methods: We performed a systematic search for high-quality up-to-date guidelines recommending dapivirine rings as PrEP using the Grading of Recommendations Assessment, Development, and Evaluation -Adolopment process. We appraised the systematic review and randomized controlled trial (RCT) evidence underpinning the selected guideline's recommendations and conducted a cost-effectiveness analysis. The Grading of Recommendations Assessment, Development, and Evaluation evidence-to-decision framework guided the adaptation of source guideline recommendations, according to our local context.

Results: We identified the 2021 World Health Organization PrEP Guidelines, informed by 2 placebo-controlled RCTs, which were included in a contemporaneous systematic review. There were 23 fewer HIV acquisitions per 1000 clients with dapivirine ring vs placebo (95% confidence interval: 10 to 34), with no increase in adverse events (moderate certainty evidence). We found no RCTs comparing dapivirine to oral PrEP or among adolescent/pregnant/breastfeeding clients. Dapivirine is less cost-effective than oral PrEP at $14.59/ring, at the current price.

Conclusions: The source guideline recommendation was adapted for the local context. Dapivirine ring seems to be less efficacious than oral PrEP, although comparative studies are lacking. Data on adolescents and pregnancy are also lacking, currently limiting the use of dapivirine as an alternative for women unable to take oral PrEP. At the current price, dapivirine is not cost-effective and unaffordable for inclusion in the South African Essential Medicines List.

背景:南非的艾滋病发病率很高,口服暴露前预防疗法(PrEP)是公共部门的标准治疗方法。为妇女提供其他预防方法可进一步减少艾滋病的感染:环境:南非公共部门:我们采用建议评估、发展和评价分级(GRADE)-Adolopment 流程,对推荐使用达匹韦林环作为 PrEP 的高质量最新指南进行了系统检索。我们对所选指南建议所依据的系统综述和随机对照试验 (RCT) 证据进行了评估,并进行了成本效益分析。根据我们当地的情况,GRADE "从证据到决策 "框架指导我们对源指南建议进行了调整:我们确定了 2021 年世界卫生组织 PrEP 指南,该指南以两项安慰剂对照 RCT 为依据,并纳入了同期的系统综述。使用达匹韦林环与安慰剂相比,每 1000 例患者中感染 HIV 的人数减少了 23 例(95% 置信区间为 10-34),不良事件没有增加(中等确定性证据)。我们没有发现将达匹韦林与口服 PrEP 进行比较的 RCT,也没有发现在青少年/孕妇/哺乳期客户中进行比较的 RCT。与口服 PrEP 相比,达匹韦林的成本效益较低,按当前价格计算为 14.59 美元/环:结论:根据当地情况对源准则建议进行了调整。达匹韦林环剂的疗效似乎不如口服 PrEP,但缺乏比较研究。此外,还缺乏有关青少年和孕妇的数据,这限制了达匹韦林作为无法服用口服 PrEP 的妇女的替代药物的使用。按照目前的价格,达匹韦林不具成本效益,无法负担得起将其列入《南非基本药物清单》的费用。
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引用次数: 0
Mortality and Associated Risk Factors Among People Living With HIV With Kaposi Sarcoma: A5263/AMC066 and A5264/AMC067. 患有卡波西肉瘤的 HIV 感染者的死亡率和相关风险因素:A5263/AMC066 和 A5264/AMC067。
IF 2.9 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-11-01 DOI: 10.1097/QAI.0000000000003484
Maganizo B Chagomerana, Carlee B Moser, Minhee Kang, Triin Umbleja, Michael D Hughes, Thomas B Campbell, Susan E Krown, Margaret Z Borok, Wadzanai Samaneka, McNeil Ngongondo, Mulinda Nyirenda, Deborah C Langat, Brenda Hoagland, Henriette Burger, Naftali Busakhala, Evangeline Njiru, Noluthando Mwelase, Rosie Mngqibisa, Mina C Hosseinipour

Background: AIDS-related Kaposi sarcoma (AIDS-KS) remains a leading cause of morbidity and mortality among people living with HIV in Africa. Mortality among people with AIDS-KS on antiretroviral therapy remains high compared with people on antiretroviral therapy who do not have AIDS-KS.

Setting: People living with HIV with Kaposi sarcoma (KS) who participated in 2 randomized trials (A5263/AMC066 [advanced stage] and A5264/AMC067 [mild-to-moderate stage]) conducted by AIDS Clinical Trials Group/AIDS Malignancy Consortium in low- and middle-income countries.

Methods: We estimated mortality rates over the trial period. Cox proportional hazards regressions were used to identify baseline characteristics associated with mortality and compared mortality rates between participants who had KS progression within 12 weeks of treatment initiation (early progression of KS [KS-PD]) and those who did not.

Results: Of the 329 and 189 eligible participants in A5263/AMC066 and A5264/AMC067, 71 (21.6%) and 24 (12.7%) died, respectively. In both trials, hypoalbuminemia was associated with increased hazards of death compared with normal albumin; A5263/AMC066: mild hypoalbuminemia (adjusted hazard ratio [aHR] = 3.01; 95% CI: 1.42 to 6.29), moderate hypoalbuminemia (aHR = 5.11; 95% CI: 2.54 to 10.29), and severe hypoalbuminemia (aHR = 14.58; 95% CI: 6.32 to 35.60), and A5264/AMC067: mild hypoalbuminemia (aHR = 5.66; 95% CI: 1.90 to 16.93) and moderate hypoalbuminemia (aHR = 7.02; 95% CI: 2.57 to 19.15). The rate of death was higher among participants who had early KS-PD than those without early KS-PD in A5263/AMC066 (HR = 5.09; 95% CI: 1.71 to 15.19) but not in A5264/AMC067 (HR = 1.74; 95% CI: 0.66 to 4.62).

Conclusions: Albumin measurements may be used to identify individuals at higher risk of death after initiating KS treatment and for evaluation of interventions that can reduce AIDS-KS mortality.

背景:艾滋病相关卡波西肉瘤(AIDS-KS)仍然是非洲艾滋病病毒感染者发病和死亡的主要原因。与接受抗逆转录病毒治疗但未感染 AIDS-KS 的患者相比,接受抗逆转录病毒治疗的 AIDS-KS 患者的死亡率仍然很高:背景:参与艾滋病临床试验小组/艾滋病恶性肿瘤联盟在中低收入国家开展的两项随机试验(A5263/AMC066 [晚期] 和 A5264/AMC067 [轻中度])的卡波西肉瘤(KS)艾滋病感染者:我们估算了试验期间的死亡率。方法:我们估算了试验期间的死亡率,采用 Cox 比例危险度回归确定了与死亡率相关的基线特征,并比较了在开始治疗后 12 周内出现 KS 进展(KS 早期进展 [KS-PD])的参与者与未出现 KS 进展的参与者之间的死亡率:在A5263/AMC066和A5264/AMC067的329名和189名合格参与者中,分别有71人(21.6%)和24人(12.7%)死亡。在这两项试验中,与白蛋白正常相比,低白蛋白血症与死亡危险增加有关;A5263/AMC066:轻度低白蛋白血症(调整后危险比 [aHR] = 3.01;95% CI:1.42 至 6.29),中度低白蛋白血症(aHR = 5.11;95% CI:2.54 至 10.29)和严重低白蛋白血症(aHR = 14.58;95% CI:6.32 至 35.60),以及 A5264/AMC067:轻度低白蛋白血症(aHR = 5.66;95% CI:1.90 至 16.93)和中度低白蛋白血症(aHR = 7.02;95% CI:2.57 至 19.15)。在 A5263/AMC066 中,有早期 KS-PD 的参与者的死亡率高于没有早期 KS-PD 的参与者(HR = 5.09;95% CI:1.71 至 15.19),而在 A5264/AMC067 中则没有(HR = 1.74;95% CI:0.66 至 4.62):白蛋白测量结果可用于识别开始接受 KS 治疗后死亡风险较高的个体,并用于评估可降低 AIDS-KS 死亡率的干预措施。
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引用次数: 0
Frequent Cocaine Use is Associated With Larger HIV Latent Reservoir Size. 频繁使用可卡因与较大的艾滋病毒潜伏库有关。
IF 3.6 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-10-01 DOI: 10.1097/qai.0000000000003472
Bradley E Aouizerat,Josephine N Garcia,Carlos V Domingues,Ke Xu,Bryan C Quach,Grier P Page,Deborah Konkle-Parker,Hector H Bolivar,Cecile D Lahiri,Elizabeth T Golub,Mardge H Cohen,Seble G Kassaye,Jack DeHovitz,Mark H Kuniholm,Nancie M Archin,Phyllis C Tien,Dana B Hancock,Eric Otto Johnson
BACKGROUNDCocaine-one of the most frequently abused illicit drugs among persons living with HIV [people living with HIV (PLWH)]-slows the decline of viral production after antiretroviral therapy and is associated with higher HIV viral load, more rapid HIV progression, and increased mortality.SETTINGWe examined the impact of cocaine use on the CD4+ T-cell HIV latent reservoir (HLR) in virally suppressed PLWH participating in a national, longitudinal cohort study of the natural and treated history of HIV in the United States.METHODSCD4+ T-cell genomic DNA from 434 women of diverse ancestry (ie, 75% Black, 14% Hispanic, 12% White) who self-reported cocaine use (ie, 160 cocaine users, 59 prior users, 215 non-users) was analyzed using the Intact Proviral HIV DNA Assay, measuring intact provirus per 106 CD4+ T cells.FINDINGSHIV latent reservoir size differed by cocaine use (ie, median [interquartile range]: 72 [14-193] for never users, 165 [63-387] for prior users, 184 [28-502] for current users), which was statistically significantly larger in both prior (P = 0.023) and current (P = 0.001) cocaine users compared with never users.CONCLUSIONSCocaine use may contribute to a larger replication competent HLR in CD4+ T cells among virologically suppressed women living with HIV. Our findings are important because women are underrepresented in HIV reservoir studies and in studies of the impact of cocaine use on outcomes among PLWH.
背景可卡因是艾滋病病毒感染者(PLWH)中最常滥用的非法药物之一,它能减缓抗逆转录病毒治疗后病毒产量的下降,并与更高的艾滋病病毒载量、更快的艾滋病进展和更高的死亡率有关。设置我们研究了使用可卡因对CD4+ T细胞HIV潜伏库(HLR)的影响,研究对象是参与美国HIV自然史和治疗史全国纵向队列研究的病毒已被抑制的艾滋病毒感染者。方法使用完整病毒 HIV DNA 检测法对 434 名不同血统(即 75% 黑人、14% 西班牙人、12% 白人)、自我报告使用过可卡因的女性(即 160 名可卡因使用者、59 名先前使用者、215 名非使用者)的 CD4+ T 细胞基因组 DNA 进行分析,测量每 106 个 CD4+ T 细胞中的完整病毒数量。结果艾滋病毒潜伏库的大小因使用可卡因而异(即,中位数[四分位数间距]:从未使用者 72 [14-193],既往使用者 165 [63-387],当前使用者 184 [28-502]),在统计学上,既往使用者(P = 0.结论可卡因的使用可能导致病毒学抑制的女性艾滋病毒感染者的 CD4+ T 细胞中 HLR 复制能力增强。我们的研究结果非常重要,因为在艾滋病毒储库研究以及可卡因使用对艾滋病毒感染者预后影响的研究中,女性所占比例较低。
{"title":"Frequent Cocaine Use is Associated With Larger HIV Latent Reservoir Size.","authors":"Bradley E Aouizerat,Josephine N Garcia,Carlos V Domingues,Ke Xu,Bryan C Quach,Grier P Page,Deborah Konkle-Parker,Hector H Bolivar,Cecile D Lahiri,Elizabeth T Golub,Mardge H Cohen,Seble G Kassaye,Jack DeHovitz,Mark H Kuniholm,Nancie M Archin,Phyllis C Tien,Dana B Hancock,Eric Otto Johnson","doi":"10.1097/qai.0000000000003472","DOIUrl":"https://doi.org/10.1097/qai.0000000000003472","url":null,"abstract":"BACKGROUNDCocaine-one of the most frequently abused illicit drugs among persons living with HIV [people living with HIV (PLWH)]-slows the decline of viral production after antiretroviral therapy and is associated with higher HIV viral load, more rapid HIV progression, and increased mortality.SETTINGWe examined the impact of cocaine use on the CD4+ T-cell HIV latent reservoir (HLR) in virally suppressed PLWH participating in a national, longitudinal cohort study of the natural and treated history of HIV in the United States.METHODSCD4+ T-cell genomic DNA from 434 women of diverse ancestry (ie, 75% Black, 14% Hispanic, 12% White) who self-reported cocaine use (ie, 160 cocaine users, 59 prior users, 215 non-users) was analyzed using the Intact Proviral HIV DNA Assay, measuring intact provirus per 106 CD4+ T cells.FINDINGSHIV latent reservoir size differed by cocaine use (ie, median [interquartile range]: 72 [14-193] for never users, 165 [63-387] for prior users, 184 [28-502] for current users), which was statistically significantly larger in both prior (P = 0.023) and current (P = 0.001) cocaine users compared with never users.CONCLUSIONSCocaine use may contribute to a larger replication competent HLR in CD4+ T cells among virologically suppressed women living with HIV. Our findings are important because women are underrepresented in HIV reservoir studies and in studies of the impact of cocaine use on outcomes among PLWH.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"40 1","pages":"156-164"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Brief Report: HIV-1 Resistance Analysis of Participants With HIV-1 and Hepatitis B Initiating Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate: A Subanalysis of ALLIANCE Data: Erratum. 简要报告:对开始接受比特拉韦/恩曲他滨/替诺福韦阿拉非那胺或多替拉韦+恩曲他滨/替诺福韦二吡呋酯治疗的 HIV-1 和乙肝患者的 HIV-1 耐药性分析:ALLIANCE数据的子分析:勘误。
IF 3.6 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-10-01 DOI: 10.1097/qai.0000000000003494
{"title":"Brief Report: HIV-1 Resistance Analysis of Participants With HIV-1 and Hepatitis B Initiating Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate: A Subanalysis of ALLIANCE Data: Erratum.","authors":"","doi":"10.1097/qai.0000000000003494","DOIUrl":"https://doi.org/10.1097/qai.0000000000003494","url":null,"abstract":"","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"4 1","pages":"202"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Markers of Maternal Bone and Renal Toxicity Through 50 Weeks Postpartum: IMPAACT 2010 (VESTED) Trial. 产后 50 周内母体骨骼和肾毒性的标志物:IMPAACT 2010 (VESTED) 试验。
IF 3.6 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-10-01 DOI: 10.1097/qai.0000000000003478
Gaerolwe Masheto,Sean S Brummel,Lauren Ziemba,John Shepherd,Tapiwa Mbengeranwa,Laarni Igawa,Anne Coletti,Dorinda Mukura,Lindie Rossouw,Gerhard Theron,Chelsea Krotje,Patrick Jean-Philippe,Nahida Chakhtoura,Haseena Cassim,Sisinyana Ruth Mathiba,Joel Maena,William Murtaugh,Lee Fairlie,Judith Currier,Risa Hoffman,Lameck Chinula,Paul E Sax,Lynda Stranix-Chibanda,Shahin Lockman,
BACKGROUNDSafety data from randomized trials of antiretrovirals in pregnancy are scarce. We evaluated maternal bone and renal data from the International Maternal Pediatric Adolescent AIDS Clinical Trials Network 2010 trial, which compared the safety and efficacy of 3 antiretroviral therapy regimens started in pregnancy: dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF), dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + FTC/TDF), and efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF).METHODSA subset of participants underwent dual-energy X-ray absorptiometry scans at postpartum week 50 only. Maternal bone mineral density (BMD) Z-scores were compared between arms. Maternal creatinine was measured at enrolment and periodically through week 50 postpartum, and by-arm differences in average weekly change in estimated creatinine clearance were compared.RESULTSSix hundred forty-three participants were randomized to DTG + FTC/TAF (N = 217) or DTG + FTC/TDF (N = 215) or EFV/FTC/TDF (N = 211). Median age = 27 years (IQR 23, 32), median CD4 count = 466 cells/mm3 (IQR 308, 624); 564 (88%) women enrolled in Africa and 479 (74%) breastfed. Week 50 postpartum dual-energy X-ray absorptiometry results from 154 women were included in the analysis. Hip and spine BMD was on average higher in women in the DTG + FTC/TAF and lower in the DTG + FTC/TDF and EFV/FTC/TDF arms, but no significant differences in BMD Z-scores were observed between treatment groups. The weekly rate of change in estimated creatinine clearance differed among treatment groups during the antepartum period, but not over the full study follow-up.CONCLUSIONSMarkers of bone and renal toxicity did not differ significantly through week 50 postpartum among women randomized to start DTG + FTC/TAF or DTG + FTC/TDF or EFV/FTC/TDF in pregnancy.
背景妊娠期抗逆转录病毒药物随机试验的安全性数据很少。我们评估了国际母婴青少年艾滋病临床试验网络 2010 试验中的母体骨骼和肾脏数据,该试验比较了孕期开始使用的三种抗逆转录病毒疗法的安全性和有效性:多托曲韦+恩曲他滨/替诺福韦-阿拉非那胺(DTG + FTC/TAF)、多托曲韦+恩曲他滨/富马酸替诺福韦二吡呋酯(DTG + FTC/TDF)和依非韦伦/恩曲他滨/富马酸替诺福韦二吡呋酯(EFV/FTC/TDF)。方法仅在产后第 50 周对部分参与者进行双能 X 射线吸收扫描。比较两组产妇的骨矿物质密度 (BMD) Z 值。结果六百四十三名参与者随机接受了 DTG + FTC/TAF (N = 217)或 DTG + FTC/TDF (N = 215)或 EFV/FTC/TDF (N = 211)治疗。中位年龄 = 27 岁 (IQR 23, 32),中位 CD4 细胞数 = 466 cells/mm3 (IQR 308, 624);564 名(88%)非洲妇女入组,479 名(74%)母乳喂养。154 名妇女的产后第 50 周双能 X 光吸收测定结果被纳入分析。DTG+FTC/TAF治疗组妇女的髋部和脊柱BMD平均较高,而DTG+FTC/TDF和EFV/FTC/TDF治疗组妇女的髋部和脊柱BMD平均较低,但治疗组之间的BMD Z-scores无显著差异。结论在产前期间,各治疗组间估计肌酐清除率的每周变化率存在差异,但在整个研究随访期间则没有差异。在产后第50周,随机开始服用DTG + FTC/TAF或DTG + FTC/TDF或EFV/FTC/TDF的妊娠期妇女的骨毒性和肾毒性指标没有显著差异。
{"title":"Markers of Maternal Bone and Renal Toxicity Through 50 Weeks Postpartum: IMPAACT 2010 (VESTED) Trial.","authors":"Gaerolwe Masheto,Sean S Brummel,Lauren Ziemba,John Shepherd,Tapiwa Mbengeranwa,Laarni Igawa,Anne Coletti,Dorinda Mukura,Lindie Rossouw,Gerhard Theron,Chelsea Krotje,Patrick Jean-Philippe,Nahida Chakhtoura,Haseena Cassim,Sisinyana Ruth Mathiba,Joel Maena,William Murtaugh,Lee Fairlie,Judith Currier,Risa Hoffman,Lameck Chinula,Paul E Sax,Lynda Stranix-Chibanda,Shahin Lockman,","doi":"10.1097/qai.0000000000003478","DOIUrl":"https://doi.org/10.1097/qai.0000000000003478","url":null,"abstract":"BACKGROUNDSafety data from randomized trials of antiretrovirals in pregnancy are scarce. We evaluated maternal bone and renal data from the International Maternal Pediatric Adolescent AIDS Clinical Trials Network 2010 trial, which compared the safety and efficacy of 3 antiretroviral therapy regimens started in pregnancy: dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF), dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + FTC/TDF), and efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF).METHODSA subset of participants underwent dual-energy X-ray absorptiometry scans at postpartum week 50 only. Maternal bone mineral density (BMD) Z-scores were compared between arms. Maternal creatinine was measured at enrolment and periodically through week 50 postpartum, and by-arm differences in average weekly change in estimated creatinine clearance were compared.RESULTSSix hundred forty-three participants were randomized to DTG + FTC/TAF (N = 217) or DTG + FTC/TDF (N = 215) or EFV/FTC/TDF (N = 211). Median age = 27 years (IQR 23, 32), median CD4 count = 466 cells/mm3 (IQR 308, 624); 564 (88%) women enrolled in Africa and 479 (74%) breastfed. Week 50 postpartum dual-energy X-ray absorptiometry results from 154 women were included in the analysis. Hip and spine BMD was on average higher in women in the DTG + FTC/TAF and lower in the DTG + FTC/TDF and EFV/FTC/TDF arms, but no significant differences in BMD Z-scores were observed between treatment groups. The weekly rate of change in estimated creatinine clearance differed among treatment groups during the antepartum period, but not over the full study follow-up.CONCLUSIONSMarkers of bone and renal toxicity did not differ significantly through week 50 postpartum among women randomized to start DTG + FTC/TAF or DTG + FTC/TDF or EFV/FTC/TDF in pregnancy.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"29 1","pages":"172-179"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Switching to Low Neurotoxic Antiretrovirals to Improve Neurocognition Among People Living With HIV-1-Associated Neurocognitive Disorder: The MARAND-X Randomized Clinical Trial. 改用低神经毒性抗逆转录病毒药物改善 HIV-1 相关神经认知障碍患者的神经认知:MARAND-X 随机临床试验》。
IF 3.6 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-10-01 DOI: 10.1097/qai.0000000000003480
Alessandro Lazzaro,Daniela Vai,Ambra Barco,Giacomo Stroffolini,Veronica Pirriatore,Giulia Guastamacchia,Marco Nigra,Valeria Ghisetti,Maria Cristina Tettoni,Giuseppe Noce,Claudia Giaccone,Mattia Trunfio,Alice Trentalange,Stefano Bonora,Giovanni Di Perri,Andrea Calcagno
BACKGROUNDThe pathogenesis of HIV-associated neurocognitive (NC) impairment is multifactorial, and antiretroviral (ARV) neurotoxicity may contribute. However, interventional pharmacological studies are limited.METHODSSingle-blind, randomized (1:1), controlled trial to assess the change of NC performance (Global Deficit Score, GDS, and domain scores) in PLWH with NC impairment randomized to continue their standard of care treatment or to switch to a less neurotoxic ARV regimen: darunavir/cobicistat, maraviroc, emtricitabine (MARAND-X). Participants had plasma and cerebrospinal fluid HIV RNA< 50 copies/mL, R5-tropic HIV, and were on ARV regimens that did not include efavirenz and darunavir. The change of resting-state electroencephalography was also evaluated. The outcomes were assessed at week 24 of the intervention through tests for longitudinal paired data and mixed-effect models.RESULTSThirty-eight participants were enrolled and 28 completed the follow-up. Global Deficit Score improved over time but with no difference between arms in longitudinal adjusted models. Perceptual functions improved in the MARAND-X, while long-term memory improved only in participants within the MARAND-X for whom the central nervous system penetration-effectiveness (CNS penetration effectiveness) score increased by ≥3. No significant changes in resting-state electroencephalography were observed.CONCLUSIONSIn this small but well-controlled study, the use of less neurotoxic ARV showed no major beneficial effect over an unchanged regimen. The beneficial effects on the memory domain of increasing CNS penetration effectiveness score suggest that ARV neuropenetration may have a role in cognitive function.
背景HIV相关神经认知(NC)损伤的发病机制是多因素的,抗逆转录病毒(ARV)的神经毒性可能是其中之一。方法单盲、随机(1:1)对照试验评估有神经认知障碍的 PLWH 的神经认知能力(全局缺陷评分、GDS 和领域评分)的变化,随机选择继续接受标准治疗或改用神经毒性较低的抗逆转录病毒疗法:达鲁那韦/可比司他、马拉韦罗、恩曲他滨(MARAND-X)。参与者的血浆和脑脊液中 HIV RNA< 50 copies/mL,HIV 为 R5-tropic,所使用的抗逆转录病毒疗法不包括依非韦伦和达鲁那韦。此外,还评估了静息状态脑电图的变化。通过纵向配对数据测试和混合效应模型,对干预第 24 周的结果进行了评估。随着时间的推移,总体缺陷评分有所改善,但在纵向调整模型中,不同干预组之间没有差异。MARAND-X治疗组的感知功能有所改善,而只有在中枢神经系统渗透效果(CNS penetration effectiveness)得分增加≥3的MARAND-X治疗组患者的长期记忆力才有所改善。结论 在这项规模较小但控制良好的研究中,使用神经毒性较低的抗逆转录病毒药物与保持不变的治疗方案相比并无重大益处。增加中枢神经系统穿透有效性评分对记忆领域的有益影响表明,抗逆转录病毒药物的神经穿透可能对认知功能有影响。
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引用次数: 0
Sleep, Sleep Apnea, and Fatigue in People Living With HIV. 艾滋病病毒感染者的睡眠、睡眠呼吸暂停和疲劳。
IF 3.6 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-10-01 DOI: 10.1097/qai.0000000000003481
Jeremy E Orr,Jazmin Velazquez,Christopher N Schmickl,Naa-Oye Bosompra,Pamela N DeYoung,Dillon Gilbertson,Atul Malhotra,Igor Grant,Sonia Ancoli-Israel,Maile Young Karris,Robert L Owens
BACKGROUNDPeople living with HIV (PLWH) often report fatigue even when viral load is suppressed. Obstructive sleep apnea (OSA), which is often associated with fatigue, is common in PLWH, but whether OSA explains fatigue in this population is unknown.SETTINGAcademic university-affiliated HIV and Sleep Medicine Clinics.METHODSPLWH, aged 18-65 years, with a body mass index of 20-35 kg/m2 and viral suppression (RNA <200 copies per mL), were recruited to undergo daytime questionnaires, including the Functional Assessment of Chronic Illness Therapy Fatigue Scale and Epworth Sleepiness Scale, 7 days of actigraphy (to determine daily sleep duration and activity amplitude and rhythms), and an in-laboratory polysomnography to assess for the presence and severity of OSA.RESULTSOf 120 subjects with evaluable data, 90 (75%) had OSA using the American Academy of Sleep Medicine 3% desaturation or arousal criteria, with an apnea-hypopnea index >5/h. There was no difference in Functional Assessment of Chronic Illness Therapy scores between those with and without OSA, although those with OSA did report more daytime sleepiness as measured using the Epworth Sleepiness Scale. In a multivariable model, predictors of fatigue included more variable daily sleep durations and decreased mean activity counts. Sleepiness was predicted by the presence of OSA.CONCLUSIONOSA was very common in our cohort of PLWH, with those with OSA reporting more sleepiness but not more fatigue. Variability in sleep duration was associated with increased fatigue. Further study is needed to determine if treatment of OSA, or an emphasis on sleep consistency and timing, improves symptoms of fatigue in PLWH.
背景艾滋病病毒感染者(PLWH)即使在病毒载量得到抑制的情况下也经常报告疲劳。阻塞性睡眠呼吸暂停(OSA)通常与疲劳有关,在艾滋病病毒感染者中很常见,但 OSA 是否能解释这一人群的疲劳问题尚不清楚。患有和未患有 OSA 的患者在慢性疾病治疗功能评估得分上没有差异,但使用 Epworth 嗜睡量表测量,患有 OSA 的患者白天嗜睡程度更高。在一个多变量模型中,疲劳的预测因素包括每日睡眠时间更长和平均活动次数减少。结论 在我们的 PLWH 群体中,OSA 非常常见,OSA 患者嗜睡程度更高,但疲劳程度并不更高。睡眠时间的不稳定性与疲劳的增加有关。需要进一步研究以确定治疗 OSA 或强调睡眠的连贯性和时间安排是否能改善 PLWH 的疲劳症状。
{"title":"Sleep, Sleep Apnea, and Fatigue in People Living With HIV.","authors":"Jeremy E Orr,Jazmin Velazquez,Christopher N Schmickl,Naa-Oye Bosompra,Pamela N DeYoung,Dillon Gilbertson,Atul Malhotra,Igor Grant,Sonia Ancoli-Israel,Maile Young Karris,Robert L Owens","doi":"10.1097/qai.0000000000003481","DOIUrl":"https://doi.org/10.1097/qai.0000000000003481","url":null,"abstract":"BACKGROUNDPeople living with HIV (PLWH) often report fatigue even when viral load is suppressed. Obstructive sleep apnea (OSA), which is often associated with fatigue, is common in PLWH, but whether OSA explains fatigue in this population is unknown.SETTINGAcademic university-affiliated HIV and Sleep Medicine Clinics.METHODSPLWH, aged 18-65 years, with a body mass index of 20-35 kg/m2 and viral suppression (RNA <200 copies per mL), were recruited to undergo daytime questionnaires, including the Functional Assessment of Chronic Illness Therapy Fatigue Scale and Epworth Sleepiness Scale, 7 days of actigraphy (to determine daily sleep duration and activity amplitude and rhythms), and an in-laboratory polysomnography to assess for the presence and severity of OSA.RESULTSOf 120 subjects with evaluable data, 90 (75%) had OSA using the American Academy of Sleep Medicine 3% desaturation or arousal criteria, with an apnea-hypopnea index >5/h. There was no difference in Functional Assessment of Chronic Illness Therapy scores between those with and without OSA, although those with OSA did report more daytime sleepiness as measured using the Epworth Sleepiness Scale. In a multivariable model, predictors of fatigue included more variable daily sleep durations and decreased mean activity counts. Sleepiness was predicted by the presence of OSA.CONCLUSIONOSA was very common in our cohort of PLWH, with those with OSA reporting more sleepiness but not more fatigue. Variability in sleep duration was associated with increased fatigue. Further study is needed to determine if treatment of OSA, or an emphasis on sleep consistency and timing, improves symptoms of fatigue in PLWH.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"60 1","pages":"192-201"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Mixed Methods Evaluation of Pharmacists' Readiness to Provide Long-Acting Injectable HIV Pre-exposure Prophylaxis in California. 对加利福尼亚州药剂师提供长效注射剂艾滋病暴露前预防的准备情况进行混合方法评估。
IF 3.6 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-10-01 DOI: 10.1097/qai.0000000000003470
Raiza M Beltran,Lauren A Hunter,Laura J Packel,Loriann De Martini,Ian W Holloway,Betty J Dong,Jerika Lam,Sandra I McCoy,Ayako Miyashita Ochoa
BACKGROUNDPre-exposure prophylaxis (PrEP) uptake remains low among people who could benefit, some of whom may prefer alternatives to oral PrEP, such as long-acting injectable pre-exposure prophylaxis (LAI-PrEP). We evaluated the potential for LAI-PrEP provision in pharmacies through a mixed methods study of pharmacists in California, where Senate Bill 159 enables pharmacists to independently provide oral PrEP.METHODSIn 2022-2023, we conducted an online cross-sectional survey of California pharmacists and pharmacy students (n = 919) and in-depth interviews with pharmacists (n = 30), both of which included modules assessing attitudes about PrEP provision. Using log-binomial regression, we estimated prevalence ratios (PRs) comparing survey participants' willingness to provide LAI-PrEP by pharmacy- and individual-level characteristics. Qualitative interview data were analyzed using Rapid Qualitative Analysis to identify factors that may affect pharmacists' provision of LAI-PrEP.RESULTSHalf of the survey participants (53%) indicated that they would be willing to administer LAI-PrEP using gluteal injection in their pharmacy. Willingness was higher among participants who worked in pharmacies that provided vaccinations or other injections (56% vs. 46%; PR: 1.2; 95% confidence interval: 1.0-1.4) and/or oral PrEP under Senate Bill 159 (65% vs. 51%; PR: 1.3; 95% confidence interval: 1.1-1.5) than among participants whose pharmacies did not. Interviewed participants reported barriers to LAI-PrEP provision, including the need for increased training and staffing, a private room for gluteal injections, better medication access, and payment for services.CONCLUSIONPharmacies offer a promising setting for increased LAI-PrEP access. However, pharmacists may require additional training, resources, and policy changes to make implementation feasible.
背景暴露前预防疗法(PrEP)在可受益人群中的使用率仍然很低,其中一些人可能更喜欢口服 PrEP 的替代品,如长效注射暴露前预防疗法(LAI-PrEP)。2022-2023 年,我们对加利福尼亚州的药剂师和药学学生(n = 919 人)进行了在线横断面调查,并对药剂师(n = 30 人)进行了深入访谈,这两项调查都包括评估药剂师对提供 PrEP 的态度的模块。我们使用对数二项式回归法估算了流行率 (PR),将调查参与者提供 LAI-PrEP 的意愿与药房和个人层面的特征进行比较。我们使用快速定性分析法分析了定性访谈数据,以确定可能影响药剂师提供 LAI-PrEP 的因素。结果半数调查参与者(53%)表示,他们愿意在药房使用臀部注射法提供 LAI-PrEP。在提供疫苗接种或其他注射服务的药房工作的参与者(56% 对 46%;PR:1.2;95% 置信区间:1.0-1.4)和/或根据参议院第 159 号法案提供口服 PrEP 服务的参与者(65% 对 51%;PR:1.3;95% 置信区间:1.1-1.5)的意愿高于其药房不提供此类服务的参与者。接受访谈的参与者报告了提供 LAI-PrEP 的障碍,包括需要增加培训和人员配备、臀部注射的私人房间、更好的药物获取途径以及服务费用。然而,药剂师可能需要接受更多培训、获得更多资源并改变政策,才能使实施工作切实可行。
{"title":"A Mixed Methods Evaluation of Pharmacists' Readiness to Provide Long-Acting Injectable HIV Pre-exposure Prophylaxis in California.","authors":"Raiza M Beltran,Lauren A Hunter,Laura J Packel,Loriann De Martini,Ian W Holloway,Betty J Dong,Jerika Lam,Sandra I McCoy,Ayako Miyashita Ochoa","doi":"10.1097/qai.0000000000003470","DOIUrl":"https://doi.org/10.1097/qai.0000000000003470","url":null,"abstract":"BACKGROUNDPre-exposure prophylaxis (PrEP) uptake remains low among people who could benefit, some of whom may prefer alternatives to oral PrEP, such as long-acting injectable pre-exposure prophylaxis (LAI-PrEP). We evaluated the potential for LAI-PrEP provision in pharmacies through a mixed methods study of pharmacists in California, where Senate Bill 159 enables pharmacists to independently provide oral PrEP.METHODSIn 2022-2023, we conducted an online cross-sectional survey of California pharmacists and pharmacy students (n = 919) and in-depth interviews with pharmacists (n = 30), both of which included modules assessing attitudes about PrEP provision. Using log-binomial regression, we estimated prevalence ratios (PRs) comparing survey participants' willingness to provide LAI-PrEP by pharmacy- and individual-level characteristics. Qualitative interview data were analyzed using Rapid Qualitative Analysis to identify factors that may affect pharmacists' provision of LAI-PrEP.RESULTSHalf of the survey participants (53%) indicated that they would be willing to administer LAI-PrEP using gluteal injection in their pharmacy. Willingness was higher among participants who worked in pharmacies that provided vaccinations or other injections (56% vs. 46%; PR: 1.2; 95% confidence interval: 1.0-1.4) and/or oral PrEP under Senate Bill 159 (65% vs. 51%; PR: 1.3; 95% confidence interval: 1.1-1.5) than among participants whose pharmacies did not. Interviewed participants reported barriers to LAI-PrEP provision, including the need for increased training and staffing, a private room for gluteal injections, better medication access, and payment for services.CONCLUSIONPharmacies offer a promising setting for increased LAI-PrEP access. However, pharmacists may require additional training, resources, and policy changes to make implementation feasible.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"113 1","pages":"142-149"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Peer-Delivered HIV Self-Testing, Sexually Transmitted Infection Self-Sampling, and Pre-exposure Prophylaxis for Transgender Women in Uganda: A Randomized Trial. 乌干达变性妇女的同伴提供 HIV 自我检测、性传播感染自我采样和接触前预防:随机试验
IF 3.6 3区 医学 Q3 IMMUNOLOGY Pub Date : 2024-10-01 DOI: 10.1097/qai.0000000000003471
Andrew Mujugira,Beyonce Karungi,Agnes Nakyanzi,Monica Bagaya,Rogers Nsubuga,Timothy Sebuliba,Olivia Nampewo,Faith Naddunga,Juliet E Birungi,Oliver Sapiri,Kikulwe R Nyanzi,Felix Bambia,Timothy Muwonge,Monica Gandhi,Jessica E Haberer
BACKGROUNDPeer-delivered HIV self-testing (HIVST) and sexually transmitted infection self-sampling (STISS) may promote adherence to oral pre-exposure prophylaxis (PrEP), but no studies have analyzed this approach among transgender women (TGW) in sub-Saharan Africa.SETTINGThe Peer study was a cluster randomized trial in Uganda (October 2020-July 2022; NCT04328025).METHODSTen TGW peer groups, each with 1 TGW peer and 8 TGW, were randomized 1:1 to receive quarterly in-clinic HIV testing with PrEP refills as standard-of-care (SOC) or SOC plus monthly peer delivery of oral-fluid HIVST, STISS, and PrEP refills (intervention). Participants were followed for 12 months. The primary outcome was PrEP adherence.RESULTSWe screened 85 TGW and enrolled 82 (41 per arm). The median age was 22 years (interquartile range [IQR] 20-24). Twelve-month retention was 88% (72/82). At the 3, 6, 9, and 12-month clinic visits, 10%, 5%, 5%, and 0% of TGW in the intervention arm had TFV-DP levels ≥700 fmol/punch, versus 7%, 15%, 7%, and 2% in the SOC arm, respectively (P = 0.18). At all visits, any detectable TFV-DP levels were significantly higher in SOC than the peer delivery group (P < 0.04). PrEP adherence was associated with sex work (incidence rate ratio 6.93; 95% CI: 2.33 to 20.60) and >10 years of schooling (incidence rate ratio 2.35; 95% CI: 1.14 to 4.84). There was a strong correlation between tenofovir detection in dried blood spots and urine (P < 0.001). No HIV seroconversions occurred.CONCLUSIONSPeer-delivered HIVST and STISS did not increase low levels of oral PrEP adherence among TGW in Uganda. Long-acting PrEP formulations should be considered for this population.
背景由同伴提供的 HIV 自我检测(HIVST)和性传播感染自我采样(STISS)可促进对口服暴露前预防药物(PrEP)的依从性,但目前还没有研究对撒哈拉以南非洲变性女性(TGW)中的这种方法进行分析。方法将十个变性女性同伴小组(每个小组有 1 名变性女性同伴和 8 名变性女性)按 1:1 的比例随机分组,接受每季度一次的诊所内 HIV 检测和 PrEP 补充药作为标准护理(SOC),或接受 SOC 加每月一次同伴提供口服流体 HIVST、STISS 和 PrEP 补充药(干预)。对参与者进行了为期 12 个月的随访。我们筛选了 85 名 TGW,并招募了 82 人(每组 41 人)。中位年龄为 22 岁(四分位数间距 [IQR] 20-24)。12 个月的保留率为 88%(72/82)。在3、6、9和12个月的门诊检查中,干预组分别有10%、5%、5%和0%的TGW的TFV-DP水平≥700 fmol/punch,而SOC组分别为7%、15%、7%和2%(P = 0.18)。在所有检查中,SOC 组检测到的任何 TFV-DP 水平都明显高于同伴给药组(P < 0.04)。坚持 PrEP 与性工作(发生率比为 6.93;95% CI:2.33 至 20.60)和受教育年限大于 10 年(发生率比为 2.35;95% CI:1.14 至 4.84)有关。在干血斑和尿液中检测到的替诺福韦有很强的相关性(P < 0.001)。结论在乌干达,同伴传播 HIVST 和 STISS 并未提高 TGW 对口服 PrEP 的依从性。对于这一人群,应考虑使用长效 PrEP 制剂。
{"title":"Peer-Delivered HIV Self-Testing, Sexually Transmitted Infection Self-Sampling, and Pre-exposure Prophylaxis for Transgender Women in Uganda: A Randomized Trial.","authors":"Andrew Mujugira,Beyonce Karungi,Agnes Nakyanzi,Monica Bagaya,Rogers Nsubuga,Timothy Sebuliba,Olivia Nampewo,Faith Naddunga,Juliet E Birungi,Oliver Sapiri,Kikulwe R Nyanzi,Felix Bambia,Timothy Muwonge,Monica Gandhi,Jessica E Haberer","doi":"10.1097/qai.0000000000003471","DOIUrl":"https://doi.org/10.1097/qai.0000000000003471","url":null,"abstract":"BACKGROUNDPeer-delivered HIV self-testing (HIVST) and sexually transmitted infection self-sampling (STISS) may promote adherence to oral pre-exposure prophylaxis (PrEP), but no studies have analyzed this approach among transgender women (TGW) in sub-Saharan Africa.SETTINGThe Peer study was a cluster randomized trial in Uganda (October 2020-July 2022; NCT04328025).METHODSTen TGW peer groups, each with 1 TGW peer and 8 TGW, were randomized 1:1 to receive quarterly in-clinic HIV testing with PrEP refills as standard-of-care (SOC) or SOC plus monthly peer delivery of oral-fluid HIVST, STISS, and PrEP refills (intervention). Participants were followed for 12 months. The primary outcome was PrEP adherence.RESULTSWe screened 85 TGW and enrolled 82 (41 per arm). The median age was 22 years (interquartile range [IQR] 20-24). Twelve-month retention was 88% (72/82). At the 3, 6, 9, and 12-month clinic visits, 10%, 5%, 5%, and 0% of TGW in the intervention arm had TFV-DP levels ≥700 fmol/punch, versus 7%, 15%, 7%, and 2% in the SOC arm, respectively (P = 0.18). At all visits, any detectable TFV-DP levels were significantly higher in SOC than the peer delivery group (P < 0.04). PrEP adherence was associated with sex work (incidence rate ratio 6.93; 95% CI: 2.33 to 20.60) and >10 years of schooling (incidence rate ratio 2.35; 95% CI: 1.14 to 4.84). There was a strong correlation between tenofovir detection in dried blood spots and urine (P < 0.001). No HIV seroconversions occurred.CONCLUSIONSPeer-delivered HIVST and STISS did not increase low levels of oral PrEP adherence among TGW in Uganda. Long-acting PrEP formulations should be considered for this population.","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"40 1","pages":"125-132"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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JAIDS Journal of Acquired Immune Deficiency Syndromes
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