The Link4Health study to evaluate the effectiveness of a combination intervention strategy for linkage to and retention in HIV care in Swaziland: protocol for a cluster randomized trial.
The Link4Health study to evaluate the effectiveness of a combination intervention strategy for linkage to and retention in HIV care in Swaziland: protocol for a cluster randomized trial.
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DOI：
10.1186/s13012-015-0291-4
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发表时间：
2015-07-19
期刊：
影响因子：
--
通讯作者：
El-Sadr WM
中科院分区：
文献类型：
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作者：
McNairy ML;Gachuhi AB;Lamb MR;Nuwagaba-Biribonwoha H;Burke S;Ehrenkranz P;Mazibuko S;Sahabo R;Philip NM;Okello V;El-Sadr WM
艾滋病毒护理连续体中的差距导致个人健康结果不佳，并增加了艾滋病毒在人口一级传播的风险。需要实施科学研究来评估旨在改善患者在整个连续过程中留存的基于临床的干预措施。Link4Health使用一种未混合的群集点随机设计来评估组合干预策略(CIS)的有效性，并将其与斯威士兰艾滋病毒诊断成人之间的联系和保留护理的标准护理进行比较。独联体的干预措施通过五种干预措施针对多种结构、行为和生物医学障碍：(1)艾滋病毒检测时的护理点CD4检测，(2)为符合条件的患者加快抗逆转录病毒疗法(ART)的启动，(3)手机预约提醒，(4)护理和预防套餐，以及(5)联系和保留的非现金财政奖励。随机单位是一个艾滋病毒诊所网络，包括一个二级设施和一个附属一级设施。10个研究单位根据实施伙伴、地理位置和艾滋病毒患者的历史数量随机进行。目标注册人数为2200人，每个人将被跟踪12个月。资格标准包括艾滋病毒阳性检测，年龄和18岁，愿意在研究单位的诊所接受艾滋病毒护理，以及同意进行研究程序。排除标准包括过去6个月内曾接受过艾滋病毒治疗，计划离开社区，以及目前怀孕。主要研究结果是在HIV检测呈阳性后1个月内联系，并在12个月内保留。次要结果包括12个月的病毒载量抑制、抗逆转录病毒治疗资格和启动的时间、参与者的可接受性和成本效益。试验状态是学习登记已经完成，后续程序正在进行中。Link4Health评估了一种新颖而实用的组合干预战略，以改善与斯威士兰成年艾滋病毒感染者的联系和保持护理。如果该战略被发现是有效的，这项研究有可能为在资源有限的情况下提供艾滋病毒服务提供信息。临床试验.gov NCT01904994
Gaps in the HIV care continuum contribute to suboptimal individual health outcomes and increased risk of HIV transmission at the population level. Implementation science studies are needed to evaluate clinic-based interventions aimed at improving retention of patients across the continuum. Link4Health uses an unblended cluster site-randomized design to evaluate the effectiveness of a combination intervention strategy (CIS) as compared to standard of care on linkage to and retention in care among HIV-diagnosed adults in Swaziland. The CIS intervention targets a multiplicity of structural, behavioral, and biomedical barriers through five interventions: (1) point-of-care CD4 testing at time of HIV testing, (2) accelerated antiretroviral therapy (ART) initiation for eligible patients, (3) mobile phone appointment reminders, (4) care and prevention packages, and (5) non-cash financial incentives for linkage and retention. The unit of randomization is a network of HIV clinics inclusive of a secondary facility coupled with an affiliated primary facility. Ten study units were randomized based on implementing partner, geographic location, and historic volume of HIV patients. Target enrollment was 2200 individuals, each to be followed for 12 months. Eligibility criteria includes HIV-positive test, age >18 years, willing to receive HIV care at a clinic in the study unit and consent to study procedures. Exclusion criteria included previous HIV care in the past 6 months, planning to leave the community, and current pregnancy. The primary study outcome is linkage within 1 month and retention at 12 months after testing HIV positive. Secondary outcomes include viral load suppression at 12 months, time to ART eligibility and initiation, participant acceptability, and cost-effectiveness. The trial status is that study enrollment is complete and follow-up procedures are ongoing. Link4Health evaluates a novel and pragmatic combination intervention strategy to improve linkage to and retention in care among adults with HIV in Swaziland. If the strategy is found to be effective, this study has the potential to inform HIV service delivery in resource-limited settings. Clinicaltrials.gov NCT01904994