Cervical Carcinoma, Human Papilloma Virus (HPV)
Conditions
Keywords
integrated screening, implementation science, Project ECHO, cervical cancer screening, selfsampling, Ethiopia
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.
Detailed description
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.
Interventions
BEHAVIORALTICHILALECH 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 the screen-triage-treat cascade. Participants will present case studies from their practice for input and guidance from other participants.
Sponsors
Albert Einstein College of Medicine
National Cancer Institute (NCI)
Addis Ababa University
University of New Mexico
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triage Examination Percentage Among Screen-Positive People Living with HIV (PLHIV) | 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) |
| Percent of PLHIV with confirmed cervical cancer who received treatment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | Percentage of eligible PLHIV screened for cervical cancer who received an HPV DNA screening test at participating clinical sites. |
| 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 | Percentage of PLHIV with a HPV positive cervical cancer screening result at participating clinical sites who received notification of their HPV-positive result. |
| 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 | 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) |
Countries
Ethiopia
Contacts
PRINCIPAL_INVESTIGATORBreanne Lott, PhD
Albert Einstein College of Medicine
Outcome results
None listed