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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
他の名前:
  • プロジェクトエコー
  • Project TICHILALECH ECHO

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Triage Examination Percentage Among Screen-Positive People Living with HIV (PLHIV)
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Total number of PLHIV screened for cervical cancer
時間枠: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
時間枠: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
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Percent of screen-positive among PLHIV
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Breanne Lott, PhD、Albert Einstein College of Medicine

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月24日

一次修了 (推定)

2029年7月1日

研究の完了 (推定)

2029年7月1日

試験登録日

最初に提出

2026年6月18日

QC基準を満たした最初の提出物

2026年6月24日

最初の投稿 (実際)

2026年7月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月1日

QC基準を満たした最後の更新が送信されました

2026年6月24日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

All quantitative and qualitative IPD collected throughout the trial.

IPD 共有時間枠

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

IPD 共有アクセス基準

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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