Leveraging Project ECHO for Improved Cervical Cancer Screening in Ethiopia

NCT07678047 | Enrolling By Invitation

• 2 other identifiers: 2025-17496U01CA294799
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Carcinoma; Human Papilloma Virus (HPV)

Keywords

integrated screening; implementation science; Project ECHO; cervical cancer screening; selfsampling; Ethiopia

Outcome Measures

Primary Outcomes (2)

• Triage Examination Percentage Among Screen-Positive People Living with HIV (PLHIV)

  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

  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

Secondary Outcomes (4)

• Total number of PLHIV screened for cervical cancer

  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

  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

  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

  Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention

Other Outcomes (6)

• Percent of screen-positive among PLHIV

  Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention

• Percent of triage-positive PLHIV

  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

  Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention

Study Arms (1)

Participation in TICHILALECH ECHO

EXPERIMENTAL

Healthcare providers and relevant stakeholders participate in TICHILALECH ECHO, a peer-to-peer virtual learning modality.

Behavioral: TICHILALECH ECHO

Interventions

TICHILALECH ECHO BEHAVIORAL

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.

Also known as: Project ECHO, Project TICHILALECH ECHO

Participation in TICHILALECH ECHO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator
• Addis Ababa University: collaborator
• University of New Mexico: collaborator
• University of Arizona: collaborator

Study Sites (1)

Addis Ababa University

Addis Ababa, Ethiopia

Location

Related Publications (35)

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MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Breanne Lott, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 1, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be made available within 1 year of the conclusion of the study. IPD will be available indefinitely.
• Access Criteria: 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.

Locations

ET (1)