Protocol for an evaluation of adherence monitoring and support interventions among people initiating antiretroviral therapy in Cape Town, South Africa-a multiphase optimization strategy (MOST) approach using a fractional factorial design.
Protocol for an evaluation of adherence monitoring and support interventions among people initiating antiretroviral therapy in Cape Town, South Africa-a multiphase optimization strategy (MOST) approach using a fractional factorial design.
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DOI：
10.1186/s13063-023-07322-z
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发表时间：
2023-05-05
期刊：
影响因子：
2.5
通讯作者：
Sabin, Lora L.
中科院分区：
文献类型：
--
作者：
Jennings, Lauren;West, Rebecca L.;Halim, Nafisa;Kaiser, Jeanette L.;Gwadz, Marya;MacLeod, William B.;Gifford, Allen L.;Haberer, Jessica E.;Orrell, Catherine;Sabin, Lora L.
关键词：
南非的艾滋病毒负担很大，有780万艾滋病毒携带者(PWH)。然而，由于抗逆转录病毒疗法(ART)的坚持和保留在护理中处于次优状态，南非只有66%的PWH被病毒抑制。标准护理只允许在常规测试显示病毒未被抑制时进行次优依从性检测。已知有几种遵守干预措施可以改善艾滋病毒的结果，但由于所需资源的原因，很少有常规实施的干预措施。因此，为资源有限的环境(RLS)确定可扩展的循证遵从性支持干预措施是当务之急。多阶段优化策略(MOST)框架允许同时评估多个干预组件及其相互作用。我们建议使用MOST来确定在开普敦初级保健诊所可行和可接受的具有最高水平疗效和成本效益的干预组合。我们将采用部分析因设计来确定最有希望的干预成分，以包括在未来的随机对照试验中测试的多组分干预措施包中。我们将招募512名参与者，在2022年3月至2024年2月期间在开普敦的三家诊所启动抗逆转录病毒治疗，并评估干预组合的可接受性、可行性和成本效益。参与者将被随机分到16种情况中的一种，三种依从性监测组件的不同组合：(1)未抑制的病毒、(2)错过的药房补充剂收集和/或(3)电子依从性监测设备检测到的遗漏剂量；以及两个依从性支持组件：(1)每周签到文本和(2)增强的同行支持。我们将评估24个月的病毒抑制(50拷贝/毫升)作为主要结果；可接受性、可行性、保真度和其他实施结果；以及成本效益。我们将使用Logistic回归模型以意向治疗的方法估计干预效果，使用描述性统计来评估实施结果，并确定最佳干预方案。据我们所知，我们的研究将是第一次使用MOST框架来确定艾滋病毒依从性监测和支持干预组件的最有效组合，以便在RLS的临床中实施。我们的发现将为务实的、持续的坚持支持提供方向，这将是结束艾滋病毒流行的关键。临床试验.gov NCT05040841。注册日期为2021年9月10日。网上版载有补充材料，可在10.1186/s13063-023-07322-z查阅。
South Africa bears a large HIV burden with 7.8 million people with HIV (PWH). However, due to suboptimal antiretroviral therapy (ART) adherence and retention in care, only 66% of PWH in South Africa are virally suppressed. Standard care only allows for suboptimal adherence detection when routine testing indicates unsuppressed virus. Several adherence interventions are known to improve HIV outcomes, yet few are implemented in routinely due to the resources required. Therefore, determining scalable evidence-based adherence support interventions for resource-limited settings (RLS) is a priority. The multiphase optimization strategy (MOST) framework allows for simultaneous evaluation of multiple intervention components and their interactions. We propose to use MOST to identify the intervention combination with the highest levels of efficacy and cost-effectiveness that is feasible and acceptable in primary care clinics in Cape Town. We will employ a fractional factorial design to identify the most promising intervention components for inclusion in a multi-component intervention package to be tested in a future randomized controlled trial. We will recruit 512 participants initiating ART between March 2022 and February 2024 in three Cape Town clinics and evaluate acceptability, feasibility, and cost-effectiveness of intervention combinations. Participants will be randomized to one of 16 conditions with different combinations of three adherence monitoring components: rapid outreach following (1) unsuppressed virus, (2) missed pharmacy refill collection, and/or (3) missed doses as detected by an electronic adherence monitoring device; and two adherence support components: (1) weekly check-in texts and (2) enhanced peer support. We will assess viral suppression (<50 copies/mL) at 24 months as the primary outcome; acceptability, feasibility, fidelity, and other implementation outcomes; and cost-effectiveness. We will use logistic regression models to estimate intervention effects with an intention-to-treat approach, employ descriptive statistics to assess implementation outcomes, and determine an optimal intervention package. To our knowledge, ours will be the first study to use the MOST framework to determine the most effective combination of HIV adherence monitoring and support intervention components for implementation in clinics in a RLS. Our findings will provide direction for pragmatic, ongoing adherence support that will be key to ending the HIV epidemic. ClinicalTrials.gov NCT05040841. Registered on 10 September 2021. The online version contains supplementary material available at 10.1186/s13063-023-07322-z.
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作者：
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影响因子：
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作者：
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DOI：
10.1097/qai.0000000000001092
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影响因子：
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作者：
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影响因子：
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影响因子：
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