Leveraging Project ECHO for Improved Cervical Cancer Screening in Ethiopia
keskiviikko 24. kesäkuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ilmoittautuminen kutsusta
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
60
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Addis Ababa, Etiopia
- Addis Ababa University
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Triage Examination Percentage Among Screen-Positive People Living with HIV (PLHIV)
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Total number of PLHIV screened for cervical cancer
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Percent of screen-positive among PLHIV
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Breanne Lott, PhD, Albert Einstein College of Medicine
Julkaisuja ja hyödyllisiä linkkejä
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- Stelzle D, Tanaka LF, Lee KK, Ibrahim Khalil A, Baussano I, Shah ASV, McAllister DA, Gottlieb SL, Klug SJ, Winkler AS, Bray F, Baggaley R, Clifford GM, Broutet N, Dalal S. Estimates of the global burden of cervical cancer associated with HIV. Lancet Glob Health. 2021 Feb;9(2):e161-e169. doi: 10.1016/S2214-109X(20)30459-9. Epub 2020 Nov 16.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
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Keskiviikko 24. kesäkuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Sunnuntai 1. heinäkuuta 2029
Opintojen valmistuminen (Arvioitu)
Sunnuntai 1. heinäkuuta 2029
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 18. kesäkuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 24. kesäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 1. heinäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 1. heinäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 24. kesäkuuta 2026
Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Urogenitaaliset kasvaimet
- Neoplasmat sivustoittain
- Neoplasmat
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Kohdun sairaudet
- Sukuelinten sairaudet, naiset
- Sukuelinten kasvaimet, naiset
- Kohdun kohdunkaulan sairaudet
- Kohdun kasvaimet
- Kohdunkaulan kasvaimet
Muut tutkimustunnusnumerot
- 2025-17496
- U01CA294799 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
All quantitative and qualitative IPD collected throughout the trial.
IPD-jaon aikakehys
IPD will be made available within 1 year of the conclusion of the study.
IPD will be available indefinitely.
IPD-jaon käyttöoikeuskriteerit
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.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
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