Fox Matthew P, Pascoe Sophie J, Huber Amy N, Murphy Joshua, Phokojoe Mokgadi, Gorgens Marelize, Rosen Sydney, Wilson David, Pillay Yogan, Fraser-Hurt Nicole
Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
BMJ Open. 2018 Jan 21;8(1):e019680. doi: 10.1136/bmjopen-2017-019680.
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.
2016年，南非国家卫生部（NDOH）发布了《慢性病国家依从性指南》，以便在南非各地分阶段实施。目前正在四个省份的12家初级卫生诊所和社区卫生中心，针对感染艾滋病毒的患者，早期实施《依从性指南》中的八项干预措施“最小套餐”。NDOH及其合作伙伴正在评估南非四个省份中五项干预措施的影响。
在NDOH的指导下并通过当地卫生当局，在12家医疗机构提供“最小套餐”。五项评估干预措施为：（1）为符合抗逆转录病毒疗法（ART）条件的患者提供快速启动咨询；（2）为接受稳定ART治疗的患者设立依从性俱乐部；（3）为接受稳定ART治疗的患者提供分散式药物配送；（4）为接受不稳定ART治疗的患者加强依从性咨询；（5）对错过预约≥5天的患者进行早期追踪。为进行评估，NDOH将12家干预诊所与12家对照诊所进行匹配，并在每对诊所中随机分配其中一家为干预诊所或对照（标准护理）诊所，从而能够采用匹配整群随机设计对干预措施进行评估。该评估使用诊所常规收集的数据，不与受试者进行研究互动，以防止影响主要结果。入组于2016年6月20日开始，2016年12月16日完成。共入组3456名患者，现在将对其进行14个月的随访，以评估对短期和最终结果的影响。主要结果包括病毒抑制、留存率和药物领取情况，在随访期间的两个时间点进行评估。
该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。研究结果将提交给主要利益相关者，并在国际会议上公布，同时发表在同行评审期刊上。
NCT02536768；预结果。
