A multilevel health system intervention for virological suppression in adolescents and young adults living with HIV in rural Kenya and Uganda (SEARCH-Youth): a cluster randomised trial.
A multilevel health system intervention for virological suppression in adolescents and young adults living with HIV in rural Kenya and Uganda (SEARCH-Youth): a cluster randomised trial.
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对肯尼亚和乌干达农村地区感染艾滋病毒的青少年和年轻人进行病毒学抑制的多层次卫生系统干预措施（SEARCH-Youth）：一项整群随机试验。
DOI：
10.1016/s2352-3018(23)00118-2
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发表时间：
2023
期刊：
影响因子：
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作者：
Ruel,Theodore;Mwangwa,Florence;Balzer,LauraB;Ayieko,James;Nyabuti,Marilyn;Mugoma,WafulaErick;Kabami,Jane;Kamugisha,Brian;Black,Douglas;Nzarubara,Bridget;Opel,Fred;Schrom,John;Agengo,George;Nakigudde,Janet;Atuhaire,HellenN;
背景在撒哈拉以南非洲，社交和认知发育事件会扰乱感染艾滋病毒的青少年和年轻人的护理和用药依从性。我们假设，与标准护理相比，动态的多层次卫生系统干预帮助青少年和年轻人及其提供者应对与生命阶段相关的事件将增加病毒抑制。方法我们对肯尼亚和乌干达农村地区15-24岁的艾滋病毒携带者和在符合条件的诊所(由政府运营并由≥25名接受护理的年轻人)接受护理的年轻人进行了一项随机开放标签的整群试验。在按地区、患者人口和以前参与搜索试验的临床随机分组后，干预诊所的参与者在常规就诊、灵活的诊所准入和快速病毒载量反馈方面接受基于生命阶段的评估。供应商有一个安全的移动平台，供供应商之间进行咨询。对照诊所遵循标准做法。主要的、预先指定的终点是在2019年12月1日之前登记并在研究诊所接受护理的参与者在2年的随访中的病毒学抑制(HIV RNA<；每毫升400个拷贝)。这项试验在ClinicalTrials.gov，NCT03848728注册，并关闭招聘。2019年1月，28家诊所入选并随机分配(14家对照，14家干预)。在2019年3月14日至2020年11月26日期间，我们在诊所招募了1988名参与者，其中1549人进入分析(785人在干预诊所，764人在对照诊所)。受试者年龄中位数为21岁(智商19~23岁)，1549名受试者中有1248人(80.6%)为女性。两年后，干预诊所参与者的平均病毒抑制比例为88%(95%可信区间85-92)，对照诊所参与者的平均比例为80%(77-84)，相当于干预的10%的有益效果(风险比[RR]1·10，95%可信区间1·03-1·16；p=0.0019)。干预导致所有性别、年龄和护理状况亚组中的病毒学抑制增加，其中在重新参与护理的人群中改善最大(RR 1·60，95%CI 1·00-2·55；p=0.025)。说明基于生命阶段的常规和系统评估，通过快速病毒负载测试及时依从性支持，以及以患者为中心、灵活的诊所准入可以帮助青少年和年轻的艾滋病毒携带者更接近普遍病毒学抑制的目标。
BackgroundSocial and cognitive developmental events can disrupt care and medication adherence among adolescents and young adults living with HIV in sub-Saharan Africa. We hypothesised that a dynamic multilevel health system intervention helping adolescents and young adults and their providers navigate life-stage related events would increase virological suppression compared with standard care.MethodsWe did a cluster randomised, open-label trial of young individuals aged 15–24 years with HIV and receiving care in eligible clinics (operated by the government and with ≥25 young people receiving care) in rural Kenya and Uganda. After clinic randomisation stratified by region, patient population, and previous participation in the SEARCH trial, participants in intervention clinics received life-stage-based assessment at routine visits, flexible clinic access, and rapid viral load feedback. Providers had a secure mobile platform for interprovider consultation. The control clinics followed standard practice. The primary, prespecified endpoint was virological suppression (HIV RNA <400 copies per mL) at 2 years of follow-up among participants who enrolled before Dec 1, 2019, and received care at the study clinics. This trial is registered with ClinicalTrials.gov, NCT03848728, and is closed to recruitment.Findings28 clinics were enrolled and randomly assigned (14 control, 14 intervention) in January, 2019. Between March 14, 2019, and Nov 26, 2020, we recruited 1988 participants at the clinics, of whom 1549 were included in the analysis (785 at intervention clinics and 764 at control clinics). The median participant age was 21 years (IQR 19–23) and 1248 (80·6%) of 1549 participants were female. The mean proportion of participants with virological suppression at 2 years was 88% (95% CI 85–92) for participants in intervention clinics and 80% (77–84) for participants in control clinics, equivalent to a 10% beneficial effect of the intervention (risk ratio [RR] 1·10, 95% CI 1·03–1·16; p=0·0019). The intervention resulted in increased virological suppression within all subgroups of sex, age, and care status at baseline, with greatest improvement among those re-engaging in care (RR 1·60, 95% CI 1·00–2·55; p=0·025).InterpretationRoutine and systematic life-stage-based assessment, prompt adherence support with rapid viral load testing, and patient-centred, flexible clinic access could help bring adolescents and young adults living with HIV closer towards a goal of universal virological suppression.FundingEunice Kennedy Shriver National Institute of Child Health and Human Development, US National Institutes of Health.
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影响因子：
2.8
作者：
Ekwunife OI;Ofomata CJ;Okafor CE;Anetoh MU;Kalu SO;Ele PU;Eleje GU
通讯作者：
Eleje GU
影响因子：
34.3
作者：
Mavhu, Webster;Willis, Nicola;Cowan, Frances M.
通讯作者：
Cowan, Frances M.
SEARCH 研究中乌干达和肯尼亚农村诊所简化艾滋病毒护理服务的成本
DOI：
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发表时间：
2018
期刊：
AIDS (London)
影响因子：
--
作者：
S. Shade;Thomas Osmand;Alex Luo;R. Aine;Elly Assurah;Betty Mwebaza;D. Mwai;A. Owaraganise;F. Mwangwa;J. Ayieko;D. Black;L. Brown;T. Clark;D. Kwarisiima;H. Thirumurthy;C. Cohen;E. Bukusi;E. Charlebois;L. Balzer;M. Kamya;M. Petersen;D. Havlir;V. Jain
通讯作者：
V. Jain
影响因子：
3.8
作者：
Inzaule, Seth C.;Kroeze, Stefanie;Hamers, Raph L.
通讯作者：
Hamers, Raph L.
影响因子：
5.2
作者：
Mburu, M.;Guze, M. A.;Wolf, H. T.
通讯作者：
Wolf, H. T.