Leveraging Project ECHO for Improved Cervical Cancer Screening in Ethiopia
24 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Addis Ababa, Etiopien
- Addis Ababa University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Participation in TICHILALECH ECHO
Healthcare providers and relevant stakeholders participate in TICHILALECH ECHO, a peer-to-peer virtual learning modality.
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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Triage Examination Percentage Among Screen-Positive People Living with HIV (PLHIV)
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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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)
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Percent of PLHIV with confirmed cervical cancer who received treatment
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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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)
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Total number of PLHIV screened for cervical cancer
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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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.
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Percent screened with an HPV DNA test among eligible PLHIV Patients
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Percentage of eligible PLHIV screened for cervical cancer who received an HPV DNA screening test at participating clinical sites.
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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HPV-Positive result notification among PLHIV
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Percentage of PLHIV with a HPV positive cervical cancer screening result at participating clinical sites who received notification of their HPV-positive result.
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Post-treatment follow-up of PLHIV with precancerous lesions after 1 year
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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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)
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percent of screen-positive among PLHIV
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Percent of screened PLHIV with a positive result in a 12- month period.
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Percent of triage-positive PLHIV
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Percent of PLHIV who received a triage examination with a positive result within 6 months.
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Percent of suspected cancer cases among PLHIV
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Percent of screened PLHIV with suspected cervical cancer.
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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PLHIV who screened positive HPV DNA but were VIA triage negative that were rescreened within the recommended screening interval
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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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).
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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PLHIV who screened negative HPV DNA who were rescreened within the recommended screening interval
Tidsram: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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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)
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Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
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Attendance during TICHILALECH ECHO sessions
Tidsram: Reported annually starting 12 months after intervention initiation, up to 3 years
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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.
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Reported annually starting 12 months after intervention initiation, up to 3 years
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Samarbetspartners och utredare
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Samarbetspartners
Utredare
- Huvudutredare: Breanne Lott, PhD, Albert Einstein College of Medicine
Publikationer och användbara länkar
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Allmänna publikationer
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
24 juni 2026
Primärt slutförande (Beräknad)
1 juli 2029
Avslutad studie (Beräknad)
1 juli 2029
Studieregistreringsdatum
Först inskickad
18 juni 2026
Först inskickad som uppfyllde QC-kriterierna
24 juni 2026
Första postat (Faktisk)
1 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Livmodersjukdomar
- Genitala sjukdomar, kvinnor
- Genitala neoplasmer, hona
- Livmoderhalssjukdomar
- Uterina neoplasmer
- Uterina cervikala neoplasmer
Andra studie-ID-nummer
- 2025-17496
- U01CA294799 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
All quantitative and qualitative IPD collected throughout the trial.
Tidsram för IPD-delning
IPD will be made available within 1 year of the conclusion of the study.
IPD will be available indefinitely.
Kriterier för IPD Sharing Access
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .