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Abstract：
In 2016, South Africa\'s National Department of Health (NDOH) launched the National Adherence Guidelines for Chronic Diseases for phased implementation throughout South Africa. Early implementation of a \'minimum package\' of eight interventions in the Adherence Guidelines for patients with HIV is being undertaken at 12 primary health clinics and community health centres in four provinces. NDOH and its partners are evaluating the impact of five of the interventions in four provinces in South Africa.
The minimum package is being delivered at the 12 health facilities under NDOH guidance and through local health authorities. The five evaluation interventions are: (1) fast track initiation counselling for patients eligible for antiretroviral therapy (ART); (2) adherence clubs for stable ART patients; (3) decentralised medication delivery for stable ART patients; (4) enhanced adherence counselling for unstable ART patients; and (5) early tracing of patients who miss an appointment by ≥5 days. For evaluation, NDOH matched the 12 intervention clinics with 12 comparison clinics and randomly allocated one member of each pair to intervention or comparison (standard of care) status within pairs, allowing evaluation of the interventions using a matched cluster-randomised design. The evaluation uses data routinely collected by the clinics, with no study interaction with subjects to prevent influencing the primary outcomes. Enrolment began on 20 June 2016 and was completed on 16 December 2016. A total of 3456 patients were enrolled and will now be followed for 14 months to estimate effects on short-term and final outcomes. Primary outcomes include viral suppression, retention and medication pickups, evaluated at two time points during follow-up.
The study received approval from the University of Witwatersrand Human Research Ethics Committee and Boston University Institutional Review Board. Results will be presented to key stakeholders and at international conferences and published in peer-reviewed journals.
NCT02536768; Pre-results.
The minimum package is being delivered at the 12 health facilities under NDOH guidance and through local health authorities. The five evaluation interventions are: (1) fast track initiation counselling for patients eligible for antiretroviral therapy (ART); (2) adherence clubs for stable ART patients; (3) decentralised medication delivery for stable ART patients; (4) enhanced adherence counselling for unstable ART patients; and (5) early tracing of patients who miss an appointment by ≥5 days. For evaluation, NDOH matched the 12 intervention clinics with 12 comparison clinics and randomly allocated one member of each pair to intervention or comparison (standard of care) status within pairs, allowing evaluation of the interventions using a matched cluster-randomised design. The evaluation uses data routinely collected by the clinics, with no study interaction with subjects to prevent influencing the primary outcomes. Enrolment began on 20 June 2016 and was completed on 16 December 2016. A total of 3456 patients were enrolled and will now be followed for 14 months to estimate effects on short-term and final outcomes. Primary outcomes include viral suppression, retention and medication pickups, evaluated at two time points during follow-up.
The study received approval from the University of Witwatersrand Human Research Ethics Committee and Boston University Institutional Review Board. Results will be presented to key stakeholders and at international conferences and published in peer-reviewed journals.
NCT02536768; Pre-results.
摘要：
2016年，南非国家卫生部（NDOH）推出了国家慢性疾病坚持指南，在整个南非分阶段实施。在四个省的12个初级保健诊所和社区卫生中心，正在尽早实施《坚持艾滋病毒患者指南》中的8项干预措施。NDOH及其合作伙伴正在评估南非四个省的五个干预措施的影响。
在NDOH的指导下，通过当地卫生当局，在12个医疗机构提供最低限度的包裹。五种评估干预措施是：（1）为有资格接受抗逆转录病毒治疗（ART）的患者提供快速启动咨询；（2）为稳定的ART患者提供依从性俱乐部；（3）为稳定的ART患者提供分散的药物治疗；（4）为不稳定的ART患者提供增强的依从性咨询；（5）及早追踪≥5天错过预约的患者。为了评估，NDOH将12个干预诊所与12个比较诊所进行匹配，并随机分配每对中的一名成员进行干预或比较（护理标准）状态。允许使用匹配的集群随机设计评估干预措施。评估使用诊所常规收集的数据，没有与受试者的研究互动，以防止影响主要结果。入学始于2016年6月20日，并于2016年12月16日完成。共纳入3456名患者，现在将随访14个月，以评估对短期和最终结果的影响。主要结果包括病毒抑制，保留和药物拾取，在随访期间的两个时间点进行评估。
这项研究获得了威特沃特斯兰德大学人类研究伦理委员会和波士顿大学机构审查委员会的批准。结果将提交给主要利益相关者和国际会议，并在同行评审的期刊上发表。
NCT02536768;预结果。
在NDOH的指导下，通过当地卫生当局，在12个医疗机构提供最低限度的包裹。五种评估干预措施是：（1）为有资格接受抗逆转录病毒治疗（ART）的患者提供快速启动咨询；（2）为稳定的ART患者提供依从性俱乐部；（3）为稳定的ART患者提供分散的药物治疗；（4）为不稳定的ART患者提供增强的依从性咨询；（5）及早追踪≥5天错过预约的患者。为了评估，NDOH将12个干预诊所与12个比较诊所进行匹配，并随机分配每对中的一名成员进行干预或比较（护理标准）状态。允许使用匹配的集群随机设计评估干预措施。评估使用诊所常规收集的数据，没有与受试者的研究互动，以防止影响主要结果。入学始于2016年6月20日，并于2016年12月16日完成。共纳入3456名患者，现在将随访14个月，以评估对短期和最终结果的影响。主要结果包括病毒抑制，保留和药物拾取，在随访期间的两个时间点进行评估。
这项研究获得了威特沃特斯兰德大学人类研究伦理委员会和波士顿大学机构审查委员会的批准。结果将提交给主要利益相关者和国际会议，并在同行评审的期刊上发表。
NCT02536768;预结果。
