Study design and protocol of a stepped wedge cluster randomized trial using a practical implementation strategy as a model for hypertension-HIV integration - the MAP-IT trial.
Study design and protocol of a stepped wedge cluster randomized trial using a practical implementation strategy as a model for hypertension-HIV integration - the MAP-IT trial.
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采用一种实用的实施策略作为高血压-HIV整合模型的阶梯式楔形群随机试验的研究设计和方案-MAP-IT试验。
DOI：
10.1186/s13012-023-01272-5
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发表时间：
2023-05-10
影响因子：
7.2
通讯作者：
Ojji, Dike
中科院分区：
文献类型：
--
作者：
Aifah, Angela A. A.;Hade, Erinn M. M.;Colvin, Calvin;Henry, Daniel;Mishra, Shivani;Rakhra, Ashlin;Onakomaiya, Deborah;Ekanem, Anyiekere;Shedul, Gabriel;Bansal, Geetha P. P.;Lew, Daphne;Kanneh, Nafesa;Osagie, Samuel;Udoh, Ememobong;Okon, Esther;Iwelunmor, Juliet;Attah, Angela;Ogedegbe, Gbenga;Ojji, Dike
随着艾滋病毒感染者非传染性疾病发病更早、更明显，在低资源高需求环境中推进综合护理网络和模式至关重要。利用当前的卫生系统倡议和解决PLWH治疗方面的差距，我们报告了我们的方法，使用后期（T4）实施研究来测试已被证明有效的实施策略的采用和可持续性，该策略已在低资源环境中最低限度地应用于高血压控制与艾滋病毒治疗的整合。我们详细介绍了我们的HIV感染者高血压管理方案：一项综合模型（MAP-IT）试验，该试验采用阶梯楔形聚类随机试验（SW-CRT）设计，以评估在尼日利亚阿克瓦伊博姆州初级卫生保健中心（PHCs）接受治疗的PLWH采用高血压治疗方案的实践促进效果。在尼日利亚联邦卫生部和社区组织的合作下，MAP-IT试验在30个初级保健中心进行。i- parhis框架指导了实施前的需求评估。RE-AIM框架将指导实施后活动，以评估实践促进对高血压项目的采用、实施保真度和可持续性以及血压控制的影响。采用SW-CRT设计，PHCs依次从高血压计划（常规护理）切换到高血压加实践促进（实验条件）。PHCs将平均招募28-32名患者，以达到最多960名高血压未控制的PLWH参与者，他们将被纵向随访血压结果。鉴于在资源匮乏的环境中需要非传染性疾病-艾滋病毒综合护理平台，MAP-IT将强调将高血压治疗纳入艾滋病毒护理的挑战和机遇，特别是在采用和可持续性方面。对我们的整合方法的评估也将突出卫生系统强化方法对PLWH血压控制的潜在影响。Clinicaltrials.gov (NCT05031819)。于2021年9月2日注册。在线版本包含补充材料，下载地址：10.1186/s13012-023-01272-5。
As people living with HIV (PLWH) experience earlier and more pronounced onset of noncommunicable diseases (NCDs), advancing integrated care networks and models in low-resource-high-need settings is critical. Leveraging current health system initiatives and addressing gaps in treatment for PLWH, we report our approach using a late-stage (T4) implementation research study to test the adoption and sustainability of a proven-effective implementation strategy which has been minimally applied in low-resource settings for the integration of hypertension control into HIV treatment. We detail our protocol for the Managing Hypertension Among People Living with HIV: an Integrated Model (MAP-IT) trial, which uses a stepped wedge cluster randomized trial (SW-CRT) design to evaluate the effectiveness of practice facilitation on the adoption of a hypertension treatment program for PLWH receiving care at primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria. In partnership with the Nigerian Federal Ministry of Health (FMOH) and community organizations, the MAP-IT trial takes place in 30 PHCs. The i-PARiHS framework guided pre-implementation needs assessment. The RE-AIM framework will guide post-implementation activities to evaluate the effect of practice facilitation on the adoption, implementation fidelity, and sustainability of a hypertension program, as well as blood pressure (BP) control. Using a SW-CRT design, PHCs sequentially crossover from the hypertension program only (usual care) to hypertension plus practice facilitation (experimental condition). PHCs will recruit and enroll an average of 28–32 patients to reach a maximum of 960 PLWH participants with uncontrolled hypertension who will be followed longitudinally for BP outcomes. Given the need for integrated NCD-HIV care platforms in low-resource settings, MAP-IT will underscore the challenges and opportunities for integrating hypertension treatment into HIV care, particularly concerning adoption and sustainability. The evaluation of our integration approach will also highlight the potential impact of a health systems strengthening approach on BP control among PLWH. Clinicaltrials.gov (NCT05031819). Registered on 2nd September 2021. The online version contains supplementary material available at 10.1186/s13012-023-01272-5.
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