Effect of a differentiated service delivery model on virological failure in adolescents with HIV in Zimbabwe (Zvandiri): a cluster-randomised controlled trial
Effect of a differentiated service delivery model on virological failure in adolescents with HIV in Zimbabwe (Zvandiri): a cluster-randomised controlled trial
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DOI：
10.1016/s2214-109x(19)30526-1
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发表时间：
2020-02-01
影响因子：
34.3
通讯作者：
Cowan, Frances M.
中科院分区：
文献类型：
--
作者：
Mavhu, Webster;Willis, Nicola;Cowan, Frances M.
艾滋病毒感染青少年面临着健康和抗逆转录病毒治疗依从性的挑战，治疗效果不佳。我们的目的是评估一个同行为主导的差异化的服务提供干预艾滋病毒的临床和心理社会的结果青少年在Zimbabwei.Methods 16个公共初级保健设施（集群）在津巴布韦的两个农村地区（宾杜拉和Shamva）随机分配（1：1），以提供加强艾滋病毒的护理支持（Zvandiri干预组）或标准的艾滋病毒护理（对照组）的青少年（年龄13-19岁）与艾滋病毒。符合条件的诊所至少有20名青少年在接受抗逆转录病毒治疗前或接受抗逆转录病毒治疗登记，并且在地理上相隔至少10公里，以尽量减少污染。如果青少年是HIV感染者，在其中一个试验诊所登记接受HIV护理，并且开始或已经接受ART治疗，则有资格入选。排除标准是身体不适无法就诊（卧床不起），精神病患者或无法给予知情同意或同意。所有诊所的艾滋病毒感染青少年都通过成人顾问获得了坚持治疗的支持。在干预诊所，为感染艾滋病毒的青少年指定了一名社区青少年治疗支持者，参加每月一次的支持小组，并接受短信、电话、家访和诊所咨询。执行力度根据每个青少年的艾滋病毒脆弱性而有所不同，每三个月重新评估一次。护理人员被邀请参加一个支持小组。主要结果是96周后死亡或病毒载量至少为1000拷贝/μ L的青少年比例。按主题收集和分析了深入的定性数据。该试验在泛非临床试验注册处注册，编号PACTR 201609001767322。结果在2016年8月15日至2017年3月31日期间，招募了500名艾滋病毒感染青少年，其中4人因检测为艾滋病毒阴性而在分组后被排除。在其余496名青少年中，212名在兹万迪里干预点招募，284名在对照点招募。入组时，中位年龄为15岁（IQR 14-17），52%的青少年为女性，81%为孤儿，47%的病毒载量至少为1000拷贝/μ L。479例（97%）在终点时有主要结局数据，包括28例死亡。在96周时，Zvandiri干预组209名青少年中有52名（25%）和对照组270名青少年中有97名（36%）的HIV病毒载量至少为1000拷贝/μ L或已死亡（调整后的患病率为0.58，95%CI为0.05）。36-0 . 94; p=0。03）。定性数据表明，多种干预措施的组成部分发挥协同作用，以改善青少年艾滋病毒感染者生活的关系环境，支持他们改善遵守。没有不良事件被判定为与研究程序相关。严重不良事件为28例死亡（Zvandiri干预组17例，对照组11例）和57例住院（Zvandiri干预组20人，对照组37例）。提供基于基础的差别化服务可以大大改善艾滋病毒感染青少年的艾滋病毒病毒学抑制，应扩大规模，以降低其高发病率，mortality.版权所有（C）2020作者。爱思唯尔有限公司出版
Background Adolescents living with HIV face challenges to their wellbeing and antiretroviral therapy adherence and have poor treatment outcomes. We aimed to evaluate a peer-led differentiated service delivery intervention on HIV clinical and psychosocial outcomes among adolescents with HIV in Zimbabwe.Methods 16 public primary care facilities (clusters) in two rural districts in Zimbabwe (Bindura and Shamva) were randomly assigned (1:1) to provide enhanced HIV care support (the Zvandiri intervention group) or standard HIV care (the control group) to adolescents (aged 13-19 years) with HIV. Eligible clinics had at least 20 adolescents in pre-ART or ART registers and were geographically separated by at least 10 km to minimise contamination. Adolescents were eligible for inclusion if they were living with HIV, registered for HIV care at one of the trial clinics, and either starting or already on ART. Exclusion criteria were being too physically unwell to attend clinic (bedridden), psychotic, or unable to give informed assent or consent. Adolescents with HIV at all clinics received adherence support through adult counsellors. At intervention clinics, adolescents with HIV were assigned a community adolescent treatment supporter, attended a monthly support group, and received text messages, calls, home visits, and clinic-based counselling. Implementation intensity was differentiated according to each adolescent's HIV vulnerability, which was reassessed every 3 months. Caregivers were invited to a support group. The primary outcome was the proportion of adolescents who had died or had a viral load of at least 1000 copies per mu L after 96 weeks. In-depth qualitative data were collected and analysed thematically. The trial is registered with Pan African Clinical Trial Registry, number PACTR201609001767322.Findings Between Aug 15, 2016, and March 31, 2017, 500 adolescents with HIV were enrolled, of whom four were excluded after group assignment owing to testing HIV negative. Of the remaining 496 adolescents, 212 were recruited at Zvandiri intervention sites and 284 at control sites. At enrolment, the median age was 15 years (IQR 14-17), 52% of adolescents were female, 81% were orphans, and 47% had a viral load of at least 1000 copies per mu L. 479 (97%) had primary outcome data at endline, including 28 who died. At 96 weeks, 52 (25%) of 209 adolescents in the Zvandiri intervention group and 97 (36%) of 270 adolescents in the control group had an HIV viral load of at least 1000 copies per mu L or had died (adjusted prevalence ratio 0.58, 95% CI 0. 36-0 . 94; p=0. 03). Qualitative data suggested that the multiple intervention components acted synergistically to improve the relational context in which adolescents with HIV live, supporting their improved adherence. No adverse events were judged to be related to study procedures. Severe adverse events were 28 deaths (17 in the Zvandiri intervention group, 11 in the control group) and 57 admissions to hospital (20 in the Zvandiri intervention group, 37 in the control group).Interpretation Peer-supported community-based differentiated service delivery can substantially improve HIV virological suppression in adolescents with HIV and should be scaled up to reduce their high rates of morbidity and mortality. Copyright (C) 2020 The Author(s). Published by Elsevier Ltd.