A multilevel intervention (Potlako+) to improve timely cancer detection and treatment initiation

项目摘要/摘要 艾滋病毒大流行加剧了低收入和中等收入国家日益增长的癌症负担， 近四分之三的癌症死亡发生在那里。LMICs中的大多数患者患有晚期癌症 阶段和有限的生存机会。LMICs癌症死亡率的有意义的改善将需要 及时诊断和与护理的有效联系，但确定有效策略的研究尚未得到 指挥。博茨瓦纳拥有关键的资源--免费医疗，包括全面的癌症 医疗保健、便利的初级诊所和国际上仿效的ART计划--但在及时性方面差距很大 癌症护理，从而提供了一个关键的机会，以创新战略，以更早地发现癌症并参与 接受治疗的病人。波特拉科飞行员试验(轨道IIa阶段)，评估针对诊断和治疗的干预措施 在博茨瓦纳的一个地区(27个社区)进行的前治疗间隔成功地增加了 与历史上相比，进入癌症护理的患者数量和具有治疗意图的治疗数量 控制。下一步，Potlako+试验-一个社区-随机(26个地理上不同的农村 社区，1：1)，务实，轨道阶段IIb，类型1混合有效性-实施试验-将评估 复杂的、理论知情的干预措施，以促进早期临床表现，症状提示 癌症，使有效的诊断，并促进迅速启动肿瘤学治疗。Potlako+试验 针对高负担癌症，占癌症死亡的60%(乳腺癌、子宫颈、肛门、阴茎、外阴和头部 和颈部)，通常可以通过早期发现症状治愈。我们利用癌症分期在 治疗开始、疗效意向治疗的发生率和治疗路径模型的持续时间 治疗间隔时间作为主要有效终点。将使用RE-AIM对实施进行评估 框架。该项目将实现三个目标：1)评估癌症症状意识的有效性 年对30岁及以上农村居民(艾滋病毒感染者和未感染艾滋病毒者)的干预 减少出现中高概率癌症综合征的时间，2)评估 缩短癌症诊断和启动时间的癌症患者综合导航平台 治疗(诊断和治疗前的间隔)，以及3)评估联合多水平 干预改善了早期治疗和治疗意向治疗的累积发生率。 了解这些干预措施的影响和实施情况将为LMIC的护理战略提供信息 增加癌症死亡风险的人群，并为发展初级保健模式做出贡献 受约束的环境。

Project Summary/Abstract The HIV pandemic has intensified the growing burden of cancer in low- and middle-income countries (LMICs), where nearly three-quarters of all cancer deaths occur. The majority of patients in LMICs have advanced cancer stage and limited opportunity for survival. Meaningful improvements in cancer mortality in LMICs will require prompt diagnosis and efficient linkage to care, however research identifying effective strategies has not been conducted. Botswana has key resources in place— free-of-charge medical care including comprehensive cancer care, accessible primary clinics, and an internationally-emulated ART program— yet large gaps in timely cancer care and thus provides a key opportunity to innovate strategies to detect cancer earlier and engage patients in care. The Potlako pilot trial (ORBIT phase IIa), evaluating an intervention targeting diagnostic and pre-treatment intervals in a single district (27 communities) in Botswana, has successfully increased the number of patients entering cancer care and number treated with curative intent compared to historical controls. As a next step, the Potlako+ trial— a community-randomized (26 geographically diverse rural communities, 1:1), pragmatic, ORBIT phase IIb, type 1 hybrid effectiveness-implementation trial— will assess a complex, theory-informed intervention to promote earlier clinic presentation with symptoms suggestive of cancer, enable efficient diagnosis, and facilitate prompt initiation of oncologic treatment. The Potlako+ trial targets high burden cancers accounting for 60% of cancer deaths (breast, cervix, anus, penis, vulva, and head and neck) which are typically curable with early detection of symptoms. We utilize cancer stage at time of treatment initiation, incidence of curative intent treatment, and the duration of Models of Pathways to Treatment intervals as primary effectiveness endpoints. Implementation will be evaluated using the RE-AIM framework. The project will achieve three aims: 1) Assess the effectiveness of cancer symptom awareness intervention with rural residents (persons living with HIV and HIV-uninfected) aged 30 years and older in decreasing time to presentation with moderate and high probability cancer syndromes, 2) Assess impact of a comprehensive cancer patient navigation platform on reducing time to diagnosis and initiation of cancer treatment (diagnostic and pre-treatment intervals), and 3) Evaluate whether the combined multilevel intervention improves early stage treatment and cumulative incidence of curative intent treatment. Understanding the impact and implementation of these interventions will inform strategies of care for LMIC populations at increasing risk of cancer death and contribute to developing models of primary care in resource- constrained environments.