Leveraging Project ECHO for Improved Cervical Cancer Screening in Ethiopia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое TICHILALECH ECHO
  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 t

Первичные конечные точки

• Triage Examination Percentage Among Screen-Positive People Living with HIV (PLHIV) [Срок оценки: 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 [Срок оценки: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention]

Вторичные конечные точки (4)

• Total number of PLHIV screened for cervical cancer [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Ethiopia · 1 центр

• Addis Ababa University — Addis Ababa

Публикации

• Ethiopian Federal Ministry of Health. National Guideline for Cervical Cancer Prevention and Control Ethiopia. 2025.
• Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdu PMID 23245608
• Beck JR, Pauker SG. The Markov process in medical prognosis. Med Decis Making. 1983;3(4):419-458. doi: 10.1177/0272989X8300300403. PMID 6668990
• Gray A, Clarke PM, Wolstenholme JL. Applied methods of cost-effectiveness analysis in health care. Oxford University Press; 2011.
• U.S. Department of Veteran Affairs. Measuring the Cost of a Program of Practice: Microcosting. Accessed 14 Dec 2020.
• Neumann PJ, Ganiats TG, Russell LB, Sanders GD, Siegel JE. Cost-effectiveness in health and medicine. New York: Oxford University Press; 2016.
• Milgrom ZZ, Severance TS, Scanlon CM, Carson AT, Janota AD, Vik TA, Duwve JM, Dixon BE, Mendonca EA. An evaluation of an Extension for Community Healthcare Outcomes (ECHO) intervention in cancer prevention and survivorship care. BMC Med Inform Decis Mak. 2022 May 17;22(1):135. doi: 10.1186/s12911-022-01874-x. PMID 35581580
• Moore DE Jr, Green JS, Gallis HA. Achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities. J Contin Educ Health Prof. 2009 Winter;29(1):1-15. doi: 10.1002/chp.20001. PMID 19288562

Идентификаторы

NCT: NCT07678047 · 2025-17496 · U01CA294799

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗