An interventional study of TICHILALECH ECHO in Cervical Carcinoma and Human Papilloma Virus (HPV), sponsored by Albert Einstein College of Medicine. Enrolling by invitation at 1 site in Ethiopia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Prevention
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Albert Einstein College of Medicine is the lead sponsor of 199 studies on the registry; 21 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 35 (80%) have results posted.
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Inclusion Criteria for Project ECHO and associated surveys, interviews, and focus group discussions:
Inclusion criteria for end service users (PLHIV) for focus group discussion and routine clinical service delivery data:
Exclusion criteria for end service users (PLHIV) for focus group discussion:
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.
Healthcare providers and relevant stakeholders participate in TICHILALECH ECHO, a peer-to-peer virtual learning modality.
Behavioral: 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 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
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)
Time frame: 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)
Time frame: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Total number of PLHIV screened for cervical cancer
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.
Time frame: 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
Percentage of eligible PLHIV screened for cervical cancer who received an HPV DNA screening test at participating clinical sites.
Time frame: 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
Percentage of PLHIV with a HPV positive cervical cancer screening result at participating clinical sites who received notification of their HPV-positive result.
Time frame: 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
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)
Time frame: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percent of screen-positive among PLHIV
Percent of screened PLHIV with a positive result in a 12- month period.
Time frame: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Percent of triage-positive PLHIV
Percent of PLHIV who received a triage examination with a positive result within 6 months.
Time frame: 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
Percent of screened PLHIV with suspected cervical cancer.
Time frame: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
PLHIV who screened positive HPV DNA but were VIA triage negative that were rescreened within the recommended screening interval
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).
Time frame: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
PLHIV who screened negative HPV DNA who were rescreened within the recommended screening interval
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)
Time frame: Baseline: 12 months prior to TICHILALECH ECHO study intervention; Post: Up to 12 months following TICHILALECH ECHO study intervention
Attendance during TICHILALECH ECHO sessions
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.
Time frame: Reported annually starting 12 months after intervention initiation, up to 3 years
Plan to share: Yes — All quantitative and qualitative IPD collected throughout the trial.
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