Evaluating a multi-component, community-based program to improve adherence and retention in care among adolescents living with HIV in Zimbabwe: study protocol for a cluster randomized controlled trial.
Evaluating a multi-component, community-based program to improve adherence and retention in care among adolescents living with HIV in Zimbabwe: study protocol for a cluster randomized controlled trial.
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DOI：
10.1186/s13063-017-2198-7
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发表时间：
2017-10-20
期刊：
影响因子：
2.5
通讯作者：
Cowan FM
中科院分区：
文献类型：
--
作者：
Mavhu W;Willis N;Mufuka J;Mangenah C;Mvududu K;Bernays S;Mangezi W;Apollo T;Araya R;Weiss HA;Cowan FM
世界卫生组织（世卫组织）的青少年艾滋病毒检测和治疗指南建议采取基于社区的干预措施，以支持抗逆转录病毒疗法的坚持和继续护理，同时承认支持这一建议的证据不足。这项随机对照试验旨在评估基于社区的心理社会干预对艾滋病毒相关和心理社会结果的有效性和成本效益。我们在两个地区进行试验。16家诊所被随机分配接受增强ART依从性支持或标准护理。两组中符合条件的个体（13-19岁且符合ART条件的HIV阳性青少年）均接受成人咨询师和护理人员提供的ART和依从性支持。干预组的青少年还参加每月一次的支助小组，被分配给指定的社区青少年治疗支助人员，并通过短信服务和电话以及家访进行跟踪。接触的类型和频率取决于青少年是否“稳定”或需要加强支持。稳定的青少年每月接受一次家访，每周接受一次个性化的短信。如果参与者错过了预定的诊所预约或支持小组会议，则进行额外的家访。需要进一步加强支助的参与者每两周接受一次家访，每周打一次电话，每天发一次短信。干预组中青少年的照顾者参加照顾者支持小组。通过在基线和48周和96周后进行的临床、行为和心理评估来评估试验结果。主要结局是96周时死亡或病毒学失败（病毒载量≥1000拷贝/ml）的比例。次要结局包括48周时的病毒学失败，护理保留（错过访视的比例）和两个时间点的心理社会结局。将根据CONSORT关于群集随机试验的指南（包括流程图）进行统计分析并报告。这项研究提供了一个独特的机会，以产生证据的影响正在进行的Zvandiri计划，为青少年艾滋病毒感染者，病毒学失败和心理社会的结果，在现实世界中交付。如果发现这种方法能够降低治疗失败率，这将加强对津巴布韦乃至整个区域进一步扩大治疗规模的支持。泛非临床试验注册数据库，注册号PACTR 201609001767322（Zvandiri试验）。于2016年9月5日注册。
World Health Organization (WHO) adolescent HIV-testing and treatment guidelines recommend community-based interventions to support antiretroviral therapy (ART) adherence and retention in care, while acknowledging that the evidence to support this recommendation is weak. This cluster randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of a psychosocial, community-based intervention on HIV-related and psychosocial outcomes. We are conducting the trial in two districts. Sixteen clinics were randomized to either enhanced ART-adherence support or standard of care. Eligible individuals (HIV-positive adolescents aged 13–19 years and eligible for ART) in both arms receive ART and adherence support provided by adult counselors and nursing staff. Adolescents in the intervention arm additionally attend a monthly support group, are allocated to a designated community adolescent treatment supporter, and followed up through a short message service (SMS) and calls plus home visits. The type and frequency of contact is determined by whether the adolescent is “stable” or in need of enhanced support. Stable adolescents receive a monthly home visit plus a weekly, individualized SMS. An additional home visit is conducted if participants miss a scheduled clinic appointment or support-group meeting. Participants in need of further, enhanced, support receive bi-weekly home visits, weekly phone calls and daily SMS. Caregivers of adolescents in the intervention arm attend a caregiver support group. Trial outcomes are assessed through a clinical, behavioral and psychological assessment conducted at baseline and after 48 and 96 weeks. The primary outcome is the proportion who have died or have virological failure (viral load ≥1000 copies/ml) at 96 weeks. Secondary outcomes include virological failure at 48 weeks, retention in care (proportion of missed visits) and psychosocial outcomes at both time points. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cluster randomized trials, including a flowchart. This study provides a unique opportunity to generate evidence of the impact of the on-going Zvandiri program, for adolescents living with HIV, on virological failure and psychosocial outcomes as delivered in a real-world setting. If found to reduce rates of treatment failure, this would strengthen support for further scale-up across Zimbabwe and likely the region more widely. Pan African Clinical Trial Registry database, registration number PACTR201609001767322 (the Zvandiri trial). Retrospectively registered on 5 September 2016.
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影响因子：
3.7
作者：
Bygrave H;Mtangirwa J;Ncube K;Ford N;Kranzer K;Munyaradzi D
通讯作者：
Munyaradzi D
DOI：
10.1111/j.1365-3156.2009.02464.x
发表时间：
2010-03
期刊：
Tropical medicine & international health : TM & IH
影响因子：
--
作者：
Langhaug LF;Sherr L;Cowan FM
通讯作者：
Cowan FM
影响因子：
6.6
作者：
Chibanda, Dixon;Verhey, Ruth;Abas, Melanie
通讯作者：
Abas, Melanie
影响因子：
3.3
作者：
Cheung, Yin Bun;Jeffries, David;Milligan, Paul
通讯作者：
Milligan, Paul
影响因子：
3
作者：
Olsen, C. Holkmann;Mocroft, A.;Lundgren, J. D.
通讯作者：
Lundgren, J. D.