Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial
Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial
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DOI：
10.1186/s13063-017-2177-z
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发表时间：
2017-10-13
期刊：
影响因子：
2.5
通讯作者：
Sanne, Ian
中科院分区：
文献类型：
--
作者：
Hoffman, Risa;Bardon, Ashley;Sanne, Ian
背景：频繁发放抗逆转录病毒治疗（ART）的要求对卫生系统提出了要求，并且由于频繁就诊的时间和成本，可能导致患者护理依从性不佳或脱离。需要严格的数据来确定最佳的 ART 配药策略，并评估较长的药物供应对保留和病毒学抑制的影响，并确定该策略是否可以降低患者和卫生系统的成本。迄今为止，还没有随机研究测试过 6 个月 ART 配药与 3 个月和标准护理方法相比的益处。 方法：本研究将是一项非盲整群随机、匹配对照试验，在马拉维和赞比亚 8200 名 18 岁及以上接受 ART 的稳定 HIV 感染者中进行，比较三种 ART 配药间隔对保留护理（主要结果）、病毒学抑制和治疗结果的影响。成本效益。将根据国家、设施类型和 ART 队列规模对 30 个组进行匹配，并随机分配到三个研究组之一：标准护理、3 个月配药和 6 个月配药。我们将对研究参与者进行跟踪，并在 12、24 和 36 个月时测量结果。一部分参与者 (n = 240) 和提供者 (n = 180) 也将参加定性访谈，以评估不同 ART 配药间隔的可行性和可接受性。讨论：本研究将是第一个比较马拉维和赞比亚稳定的 HIV 感染者的 6 个月和 3 个月 ART 配药间隔的研究。我们关注与国家计划相关的成果，包括保留、病毒抑制和成本效益。该研究的结果将帮助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部结果，并有助于为卫生政策决策提供信息。
Background: 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.Methods: 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.Discussion: 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.