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Leveraging Project ECHO for Improved Cervical Cancer Screening in Ethiopia

2026年6月24日 更新者:Albert Einstein College of Medicine

Leveraging Project ECHO for Improved Cervical Cancer Screening in Ethiopia: An Implementation Study of Integrated HPV Selfsampling in HIV Care Centers

Project TICHILALECH ("she can" in Amharic), a five-year, implementation science study, is focused on improving cervical cancer screening, triage, and treatment and integration with human immunodeficiency virus (HIV) care at five Ethiopian hospitals, with a focus on human papillomavirus (HPV) self-collection as the recommended screening strategy for people living with HIV (PLHIV). To improve implementation of screening and treatment, Project ECHO (Extension for Community Healthcare Outcomes), a peer-based, virtual, knowledge sharing model, will be used to convene healthcare providers and stakeholders over a period of approximately three years (2026-2029). A customized curriculum is developed featuring didactic lectures, case-based presentations, and experience sharing for peer-mentoring. A pre/post study design will measure changes in delivery of clinical services, such as the proportion of HPV-positive patients that are appropriately triaged and treated, before and after each hospital's participation in the TICHILALECH ECHO intervention.

研究概览

地位

邀请报名

详细说明

Each year, more than 500,000 women are diagnosed with cervical cancer (CxCa), a preventable cancer caused by human papillomavirus (HPV) that disproportionately burdens low- and middle-income countries (LMICs). Women living with HIV (WLHIV) are up to six times more likely to develop CxCa, making them an especially important target population for prevention and control efforts. In Ethiopia, a national CxCa screening program was established in 2016 and screening guidelines for PLHIV have recently been updated to shift from visual inspection with acetic acid (VIA) to HPV DNA testing. There is limited data on the provider or facility adherence to the "screen-triage-and treat" guidelines and algorithm for HPV testing; Up to 30% of WLHIV screen positive for HPV and the proportions that are appropriately triaged with VIA and treated if needed are currently unknown. Implementation challenges to CxCa screening, as reported by health providers, include high variability in practices between screening sites, and insufficient training and monitoring and evaluation. This research study seeks to explore and address these challenges through an implementation science study of point-of-care HPV self-sampling integrated with routine HIV care in antiretroviral therapy (ART) clinics of hospitals, thereby leveraging established HIV care infrastructure for improved cancer control of PLHIV.

The overarching goal of Project TICHILALECH, this five-year implementation science study, is to enhance the screen-triage-treat cascade for HPV testing of PLHIV that is integrated with routine HIV care in Ethiopia. A mixed-method situational analysis including key stakeholder interviews, document review, and a landscape survey to assess facility readiness of HIV care centers to implement integrated, point-of-care CxCa screening and understand barriers and facilitators to HPV testing implementation in Ethiopia informs the development of the ECHO curriculum and program. Various cadres of health providers, the implementers of CxCa screening and HIV care at the five sites, and other actors such as laboratory personnel and administrators will participate in TICHILALECH ECHO. Key indicators for service delivery will be extracted and calculated from electronic medical records, paper-based screening logs, and paper-based charts to determine the proportion of screening eligible PLHIV that are screened, resulted, followed up with, linked to triage, and treated as appropriate. A pre/post study design will examine whether participating in ECHO and sharing experiences between sites results in increased triage and treatment rates, acceptability, appropriateness, and feasibility. Two low-performing sites will receive additional technical support through facilitated health equity action labs.

NOTE: This ClinicalTrials.gov registration exclusively focuses on Aim 2 of this study, participation TICHILALECH ECHO and related data collection and analysis, including service delivery measures for end users.

研究类型

介入性

注册 (估计的)

60

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。

学习地点

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

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria for Project ECHO and associated surveys, interviews, and focus group discussions:

  • 18 years or older
  • Willingness and ability to provide informed consent and participate in virtual, peer-mentoring through Project ECHO
  • Profession: Healthcare provider, any education/training/cadre with experience relevant to the delivery of cervical cancer screening and treatment or HIV care (e.g., cervical cancer screening, gynecologist, gynecological oncologist, or HIV/ ART provider), or other stakeholder (e.g., personnel at laboratories or health bureaus, administrators, ART data clerks)
  • Can communicate in English or Amharic (national language of Ethiopia)
  • Able and willing to meaningfully contribute in the virtual, peer-learning community of Project ECHO

Inclusion criteria for end service users (PLHIV) for focus group discussion and routine clinical service delivery data:

  • 25 years or older (in accordance with Ethiopia's national cervical cancer screening guidelines for PLHIV)
  • Have been diagnosed with HIV
  • Have a history of cervical cancer screening that was performed at one of the five study sites, either during the course of our study or previously
  • Were screened with primary HPV DNA testing during the course of the study intervention period
  • Are eligible for cervical cancer screening in accordance with Ethiopia's national cervical cancer screening guidelines (e.g., have an intact cervix)

Exclusion criteria for end service users (PLHIV) for focus group discussion:

  • HIV negative status
  • Age under 25 years
  • Any physical or mental disability that prevents the individual from consenting to cervical cancer screening and/or study participation
  • Patients without an intact cervix (e.g. a history of hysterectomy)
  • Anyone ineligible for cervical cancer screening in accordance with Ethiopia's national cervical cancer screening guidelines

Note: Routine clinical service delivery data of PLHIV will be reviewed to determine intervention effect of providers participating in Project ECHO. PLHIV are not considered participants of the trial and are not consented.

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:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 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:Participation in TICHILALECH ECHO
Healthcare providers and relevant stakeholders participate in TICHILALECH ECHO, a peer-to-peer virtual learning modality.
TICHILALECH ECHO, the study intervention, is a provider training and peer-mentoring intervention that will be delivered through 1-hour virtual sessions with multidisciplinary teams of cervical cancer screening stakeholders, organized in modules with sessions delivered at a regular cadence across three years. Project ECHO sessions will address challenges to improving the screen-triage-treat cascade of care identified by a situational assessment, however, the study will not directly intervene on the screen-triage-treat cascade. Participants will present case studies from their practice for input and guidance from other participants.
其他名称:
  • 回声计划
  • Project TICHILALECH ECHO

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
Triage Examination Percentage Among Screen-Positive People Living with HIV (PLHIV)
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percentage of screen-positive PLHIV who received at least one timely (i.e., within 6 months of a positive screening result) triage examination (i.e., HPV partial genotyping, colposcopy, visual inspection with acetic acid (VIA), or cytology), assessed separately for the baseline period (i.e., the 12 month period prior to ECHO intervention implementation) and the post-intervention period (i.e., 12 month period following ECHO intervention implementation)
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percent of PLHIV with confirmed cervical cancer who received treatment
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percentage of screen-positive and triage-positive PLHIV who have received timely (i.e., within 6 months of a positive triage result) treatment (i.e., Loop Electrosurgical Excision Procedure (LEEP), thermal ablation, or cryotherapy), assessed separately for the baseline period (i.e., 12 month period prior to ECHO intervention implementation) and the post-intervention period (i.e., 12 month period following ECHO intervention implementation)
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention

次要结果测量

结果测量
措施说明
大体时间
Total number of PLHIV screened for cervical cancer
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Number of patients who were HIV-positive who were screened (using HPV DNA testing, VIA, or cytology) for cervical cancer (count) in a 12 month period.
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percent screened with an HPV DNA test among eligible PLHIV Patients
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percentage of eligible PLHIV screened for cervical cancer who received an HPV DNA screening test at participating clinical sites.
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
HPV-Positive result notification among PLHIV
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percentage of PLHIV with a HPV positive cervical cancer screening result at participating clinical sites who received notification of their HPV-positive result.
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Post-treatment follow-up of PLHIV with precancerous lesions after 1 year
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percentage of PLHIV treated for precancerous lesions - including LEEP, thermal ablation, or cryotherapy - who return for a timely follow-up screening (i.e., within 1.5 years of treatment as per the recommendation according to Ethiopia's National Cervical Cancer Guidelines for post-treatment follow-up rescreening after 1 year), assessed separately for the baseline period (i.e., 12 month period prior to ECHO intervention implementation) and the post-intervention period (i.e., 12 month period following ECHO intervention implementation)
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention

其他结果措施

结果测量
措施说明
大体时间
Percent of screen-positive among PLHIV
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percent of screened PLHIV with a positive result in a 12- month period.
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percent of triage-positive PLHIV
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percent of PLHIV who received a triage examination with a positive result within 6 months.
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percent of suspected cancer cases among PLHIV
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percent of screened PLHIV with suspected cervical cancer.
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
PLHIV who screened positive HPV DNA but were VIA triage negative that were rescreened within the recommended screening interval
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percentage of eligible PLHIV who were primary HPV-positive and VIA triage negative who received timely rescreening (i.e., up to 1.5 years after their VIA triage appointment as per the recommendation according to Ethiopia's National Cervical Cancer Guidelines for rescreening to occur after 1 year).
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
PLHIV who screened negative HPV DNA who were rescreened within the recommended screening interval
大体时间:Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percentage of eligible PLHIV with a prior negative screening result who received timely rescreening (i.e., within 3.5 years as per the recommendation according to Ethiopia's National Cervical Cancer Program Guidelines recommendation to rescreen HPV negative PLHIV after 3 years), assessed separately for the baseline period (i.e., 12 month period prior to ECHO intervention implementation) and the post-intervention period (i.e., 12 month period following ECHO intervention implementation)
Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Attendance during TICHILALECH ECHO sessions
大体时间:Reported annually starting 12 months after intervention initiation, up to 3 years
Minimum number of participants attending a TICHILALECH ECHO session, maximum number of participants attending a TICHILALECH ECHO session, and mean number of participants attending a TICHILALECH ECHO session during each year of Project TICHILALECH ECHO implementation.
Reported annually starting 12 months after intervention initiation, up to 3 years

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。

调查人员

  • 首席研究员:Breanne Lott, PhD、Albert Einstein College of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2026年6月24日

初级完成 (估计的)

2029年7月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年6月18日

首先提交符合 QC 标准的

2026年6月24日

首次发布 (实际的)

2026年7月1日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月24日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

All quantitative and qualitative IPD collected throughout the trial.

IPD 共享时间框架

IPD will be made available within 1 year of the conclusion of the study. IPD will be available indefinitely.

IPD 共享访问标准

All data and metadata from this study will be available electronically on the Inter-university Consortium of Political and Social Research (ICPSR) website, a Core TrustSeal certified repository. The only requirements to access downloadable, de-identified data through ICPSR are user registration and agreement to ICPSR's Terms of Use.

Restricted-Use Data Access: Human subject information will be fully de-identified before ICPSR disseminates it to the public. Access to information that may be used to identify human subjects, even indirectly, will be managed according to ICPSR restricted-use data access policy and procedures to maintain privacy and confidentiality protections of human subjects. Reuse, Attribution and Redistribution: Users agree to make no attempt to identify human subjects, cite the data/DOI, and not redistribute the data without ICPSR written permission.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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