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

项目概要/摘要 艾滋病毒大流行加剧了中低收入国家日益增加的癌症负担， 近四分之三的癌症死亡发生在那里。LMIC中的大多数患者患有晚期癌症 生存的机会有限。低收入国家癌症死亡率的显著改善需要 及时诊断和与护理的有效联系，然而，确定有效战略的研究尚未得到 进行。博茨瓦纳拥有关键资源-免费医疗，包括全面的癌症 医疗保健，可访问的初级诊所和国际效仿的ART计划-但在及时 癌症护理，从而提供了一个关键的机会，创新战略，以早期发现癌症， 病人在照顾。Potlako试点试验（ORBIT IIa期），评估了一种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）， 与历史相比，接受癌症治疗的患者数量和接受治愈性治疗的患者数量 对照作为下一步，Potlako+试验-一项社区随机（26个地理位置不同的农村 社区，1：1），务实，轨道IIb期，1型混合动力的有效性实施试验-将评估一个 复杂的，理论知情的干预，以促进早期临床表现与症状提示 癌症，使有效的诊断，并促进迅速启动肿瘤治疗。Potlako+试验 针对占癌症死亡60%的高负担癌症（乳腺癌、宫颈癌、肛门癌、阴茎癌、外阴癌和头颈癌） 和颈部），其通常可通过早期发现症状而治愈。我们利用癌症分期， 治疗开始时间、治愈性意向治疗的发生率以及 治疗间隔作为主要有效性终点。将使用RE-AIM评估实施情况 框架.该项目将达到三个目的：1）评估癌症症状意识的有效性 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 减少出现中度和高度概率癌症综合征的时间，2）评估 全面的癌症患者导航平台，可缩短诊断和启动癌症的时间 治疗（诊断和治疗前间隔），以及3）评价组合的多水平 干预改善了早期治疗和治愈性治疗的累积发生率。 了解这些干预措施的影响和实施将为LMIC的护理战略提供信息 癌症死亡风险增加的人群，并有助于发展初级保健模式， 受限环境。

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.