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AYAHIV 以肿瘤学为重点的劳动力的基于角色的责任 (ARROW)

2026年11月2日 更新者:Implenomics

为赞比亚艾滋病毒感染者提供综合癌症控制干预措施

Adolescents and young adults living with HIV experience higher premature mortality from cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized for this disproportionally impacted cohort. In this study, the investigators will test peer-to-peer education and support strategies to increase use of early diagnosis services in HIV treatment facilities and improve compliance with cancer treatment in the cancer center.

研究概览

详细说明

Zambia is a global epicenter for HIV with a large number of adolescents and young adults living with HIV (AYAHIV). Compared with their uninfected peers, AYAHIV are at increased risk of developing cancer, most frequently Kaposi sarcoma (KS), non-Hodgkin's lymphoma (NHL), and cervical cancer (CC). To reduce this premature mortality, evidence-based strategies should be implemented to both diagnose cancers at an earlier stage and help AYAHIV complete recommended cancer treatment. The investigators will use theory-informed multilevel strategies to create the AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW) program to increase uptake of services for early diagnosis and improve compliance with cancer treatment for KS, NHL, and CC. Our overall approach is based on the evidence-based strategy of peer support for engagement and learning. At the individual level, the investigators will address barriers by embedding peer counselors to support AYAHIV. At the provider level, the investigators will create a peer-to-peer learning network to build linkages between those specializing in pediatric and adult HIV treatment and cancer care. At the health care system level, the investigators will bring together health care administrators and Zambian Ministry of Health policy makers to review barriers and to develop and implement collaborative solutions. The investigators will use implementation science methods to evaluate effectiveness, implementation outcomes, and cost-effectiveness of the ARROW program compared with a one-time education campaign by pursuing the following aims:

Aim 1. Conduct randomized trials to compare the ARROW program with the one-time education campaign in increasing services received by AYAHIV to facilitate early diagnosis (physical exam for KS and NHL, CC screening, and timely diagnostic testing) and in improving adherence to cancer treatment.

Aim 2. Use mixed methods to assess implementation outcomes of the ARROW program compared with one-time education based on acceptability, feasibility, appropriateness, fidelity, and sustainability.

Aim 3. Perform economic evaluations to assess cost-effectiveness and return-on-investment scenarios.

Successful completion of these aims will yield a set of data-driven strategies that can be scaled up to reduce premature cancer mortality among AYAHIV. To support future implementation efforts, the investigators will generate incremental cost-effectiveness estimates, conduct policy simulations, evaluate implementation outcomes, and assess challenges and facilitators to optimize the ARROW program. The model tested in Zambia can serve as a blueprint for other Sub-Saharan African countries to ensure AYAHIV receive optimal services to facilitate early diagnosis and ensure completion of guideline-recommended treatments. The ARROW program will also provide a framework for implementing expanded services, such as preventive services and survivorship care, to further reduce the burden of cancer AYAHIV face.

研究类型

介入性

注册 (估计的)

4100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Lusaka、赞比亚
        • 招聘中
        • Public Health Facilities
        • 接触:
          • Ronald Mungoni

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 至 39年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 15 to 39 years of age at the time of study enrolment, on antiretroviral medication (ART) for at least 6 months and with no pending plans to move from current residence during the 3-year study duration

Exclusion Criteria:

  • pregnant at study enrolment

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:放映
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:ARROW strategies

The ARROW strategies which use peer-peer support at the patient level (through peer counselors), at the provider level (through peer lead education sessions) and at the health system level (through a health collaborative forum) to deliver high quality screenings and ensure cancer treatment completion.

ARROW strategies are peer-to-peer support at the patient, provider and health system levels

有源比较器:One-time education

The comparator arm participants will receive one-time education and usual care services.

The comparison group will receive a one-time education campaign that will provide informational brochures to adolescents and young adults living with HIV and HIV providers

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion who complete screening/physical examination
大体时间:12 months after study enrollment

Number who complete screening/physician exams

12 months after study enrollment
Proportion who complete recommended cancer treatment modalities
大体时间:12 months after diagnosis

Number who complete treatment

12 months after diagnosis

次要结果测量

结果测量
措施说明
大体时间
Proportion who complete recommended follow-up supplemental diagnostic procedures
大体时间:3 months from receipt of follow-up referral

Number who complete follow-up

3 months from receipt of follow-up referral
Proportion who initiate cancer treatment
大体时间:3 months from diagnosis

Number who initiate treatment

3 months from diagnosis
Proportion alive at 12 months
大体时间:12 months after diagnosis

Number alive at 12 months

12 months after diagnosis

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年5月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年8月31日

研究注册日期

首次提交

2023年8月15日

首先提交符合 QC 标准的

2023年8月15日

首次发布 (实际的)

2023年8月22日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年1月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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