Hoffman Risa, Bardon Ashley, Rosen Sydney, Fox Matthew, Kalua Thoko, Xulu Thembi, Taylor Angela, Sanne Ian
Division of Infectious Diseases, Department of Medicine, UCLA, 10833 Le Conte Ave, 37-121 CHS, Los Angeles, CA, 90095, USA.
EQUIP, 3rd Floor Outspan Building, 1006 Lenchen North Avenue, Centurion, South Africa.
Trials. 2017 Oct 13;18(1):476. doi: 10.1186/s13063-017-2177-z.
Requirements for frequent dispensing of antiretroviral therapy (ART) place demands on health systems and can lead to suboptimal adherence and disengagement in care for patients due to the time and cost of frequent clinic visits. Rigorous data are needed to define optimal ART dispensing strategies and to evaluate the impact of a longer medication supply on retention and virologic suppression and determine whether this strategy lowers costs for both the patient and the health system. To date, no randomized studies have tested the benefits of 6-month dispensing of ART compared to 3-month and standard of care approaches.
This study will be an unblinded cluster-randomized, matched controlled trial conducted among 8200 stable, HIV-infected individuals age 18 years and older on ART in Malawi and Zambia, to compare three ART dispensing intervals on the outcomes of retention in care (primary outcome), virologic suppression, and cost-effectiveness. Thirty clusters will be matched according to country, facility type, and ART cohort size and randomized to one of three study arms: standard of care, 3-month dispensing, and 6-month dispensing. Study participants will be followed, and outcomes will be measured at 12, 24, and 36 months. A subset of participants (n = 240) and providers (n = 180) will also participate in qualitative interviews to evaluate feasibility and acceptability of different ART dispensing intervals.
This study will be the first to compare 6-month and 3-month ART dispensing intervals for stable, HIV-infected individuals in Malawi and Zambia. We focus on outcomes relevant to country programs, including retention, virologic suppression, and cost-effectiveness. Results from the study will help resource-limited health systems better understand the full scope of outcomes resulting from various ART dispensing intervals and help to inform health policy decisions.
ClinicalTrials.gov, NCT03101592 . Registered on 18 March 2017. Pan African Clinical Trials, PACTR201706002336105 . Registered on 2 June 2017.
抗逆转录病毒疗法（ART）需要频繁配药，这对卫生系统提出了要求，并且由于频繁门诊的时间和成本，可能导致患者依从性欠佳和脱离治疗。需要严谨的数据来确定最佳的ART配药策略，并评估延长药物供应对治疗留存率和病毒学抑制的影响，以及确定该策略是否能降低患者和卫生系统的成本。迄今为止，尚无随机研究测试与3个月配药及标准治疗方法相比，6个月配药的ART的益处。
本研究将在马拉维和赞比亚8200名年龄在18岁及以上、接受ART治疗且病情稳定的HIV感染者中进行一项非盲整群随机、匹配对照试验，以比较三种ART配药间隔在治疗留存率（主要结局）、病毒学抑制和成本效益方面的结果。30个群组将根据国家、机构类型和ART队列规模进行匹配，并随机分配到三个研究组之一：标准治疗、3个月配药和6个月配药。将对研究参与者进行随访，并在12个月、24个月和36个月时测量结局。还将有一部分参与者（n = 240）和提供者（n = 180）参与定性访谈，以评估不同ART配药间隔的可行性和可接受性。
本研究将首次比较马拉维和赞比亚病情稳定的HIV感染者6个月和3个月ART配药间隔的情况。我们关注与国家项目相关的结局，包括治疗留存率、病毒学抑制和成本效益。研究结果将有助于资源有限的卫生系统更好地了解各种ART配药间隔所产生的全面结局，并有助于为卫生政策决策提供信息。
ClinicalTrials.gov，NCT03101592。于2017年3月18日注册。泛非临床试验，PACTR201706002336105。于2017年6月2日注册。
