Implementation and scale-up of a single-visit, screen-and-treat approach with thermal ablation for sustainable cervical cancer prevention services: a protocol for a stepped-wedge cluster randomized trial in Kenya.
Implementation and scale-up of a single-visit, screen-and-treat approach with thermal ablation for sustainable cervical cancer prevention services: a protocol for a stepped-wedge cluster randomized trial in Kenya.
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DOI：
10.1186/s13012-023-01282-3
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发表时间：
2023-06-26
影响因子：
7.2
通讯作者：
Gimbel, Sarah
中科院分区：
文献类型：
--
作者：
Shin, Michelle B.;Oluoch, Lynda Myra;Barnabas, Ruanne V.;Baynes, Colin;Fridah, Harriet;Heitner, Jesse;Kerubo, Mary Bernadette;Ngure, Kenneth;Pinder, Leeya F.;Thomas, Katherine K.;Mugo, Nelly Rwamba;Gimbel, Sarah
关键词：
在低收入和中等收入国家（LMICs），一项重要的宫颈癌预防策略是单次筛查和治疗（SV-SAT）方法，使用醋酸目视检查（VIA）和消融治疗结合冷冻疗法来管理癌前病变。虽然SV-SAT结合VIA和冷冻疗法已经确立了疗效，但其人群覆盖率和对减少宫颈癌负担的影响仍然很低。在肯尼亚，估计30-49岁妇女接受宫颈癌筛查的比例为16%，高达70%的筛查阳性妇女没有接受治疗。热消融治疗宫颈癌前病变是世界卫生组织推荐的，有可能克服与冷冻治疗相关的后勤挑战，促进SV-SAT方法的实施，并提高筛查阳性妇女的治疗率。在这项为期5年的前瞻性、楔形步进随机试验中，我们计划在肯尼亚中部的10家生殖健康诊所实施和评估SV-SAT方法，使用VIA和热消融。该研究旨在通过三个目标制定和评估实施策略，为通过VIA和热消融的SV-SAT方法在全国范围内的推广提供信息：(1)与关键利益相关者（患者、提供者、系统级）采用多层次参与式方法制定适合当地的实施策略；(2)采用VIA和热消融的SV-SAT方法，并评估临床和实施结果；(3)与单次就诊、筛查和治疗的冷冻治疗方法相比，评估VIA和热消融的SV-SAT方法对预算的影响。我们的研究结果将为SV-SAT方法与VIA和热消融的全国推广提供信息。我们预计，与使用冷冻疗法的标准护理相比，这种干预措施以及量身定制的实施策略将提高宫颈癌筛查和治疗的采用率和可持续性。NCT05472311。
An important cervical cancer prevention strategy in low- and middle-income countries (LMICs) has been single-visit screen-and-treat (SV-SAT) approach, using visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy to manage precancerous lesions. While SV-SAT with VIA and cryotherapy have established efficacy, its population level coverage and impact on reducing cervical cancer burden remains low. In Kenya, the estimated cervical cancer screening uptake among women aged 30–49 is 16% and up to 70% of screen-positive women do not receive treatment. Thermal ablation for treatment of precancerous lesions of the cervix is recommended by the World Health Organization and has the potential to overcome logistical challenges associated with cryotherapy and facilitate implementation of SV-SAT approach and increase treatment rates of screen-positive women. In this 5-year prospective, stepped-wedge randomized trial, we plan to implement and evaluate the SV-SAT approach using VIA and thermal ablation in ten reproductive health clinics in central Kenya. The study aims to develop and evaluate implementation strategies to inform the national scale-up of SV-SAT approach with VIA and thermal ablation through three aims: (1) develop locally tailored implementation strategies using multi-level participatory method with key stakeholders (patient, provider, system-level), (2) implement SV-SAT approach with VIA and thermal ablation and evaluate clinical and implementation outcomes, and (3) assess the budget impact of SV-SAT approach with VIA and thermal ablation compared to single-visit, screen-and-treat method using cryotherapy. Our findings will inform national scale-up of the SV-SAT approach with VIA and thermal ablation. We anticipate that this intervention, along with tailored implementation strategies will enhance the adoption and sustainability of cervical cancer screening and treatment compared to the standard of care using cryotherapy. NCT05472311.
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影响因子：
12.7
作者：
Glasgow, RE;Vogt, TM;Boles, SM
通讯作者：
Boles, SM
DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
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作者：
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作者：
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