C-3002: Enhancing Cervical Cancer Screening Access and Follow-up Care at 'CASCADE' Clinical Sites in the United States (CASCADE3002)

May 18, 2026 updated by: UNC Lineberger Comprehensive Cancer Center

The purpose of the CASCADE-3002 project is to improve access to cervical cancer screening among women with Human Immunodeficiency Virus (HIV) receiving care at U.S.-based CASCADE clinical sites. This study will assess the cervical cancer screening cascade and identify multilevel factors that impede access to screening among women with HIV attending Infectious Disease clinics in Georgia and Maryland. In parallel, the study will explore and develop implementation strategies for human papillomavirus (HPV) self-collection to increase screening uptake, adherence, and appropriate clinical follow-up in this population at elevated risk for cervical cancer.

Cervical cancer remains a preventable malignancy; however, women with HIV are at substantially increased risk and experience higher rates of cervical cancer compared with women without HIV. The World Health Organization has called for the global elimination of cervical cancer as a public health problem, defined as fewer than 4 incident cases per 100,000 women annually, with targets for vaccination, screening, and treatment coverage. Although the United States has the tools to approach near-elimination, disparities in healthcare access and screening persist, particularly among women with HIV.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study consists of Aim 1 (with sub-aims 1a and 1b) and Aim 2. Aim 1a will document the cervical cancer screening cascade among screen-eligible women with HIV (WWH) receiving care in Infectious Disease HIV clinics affiliated with U.S.-based CASCADE Clinical Sites in Georgia (CS4) and Maryland (CS8). Aim 1a will involve a retrospective electronic health record chart review conducted by clinic staff to determine the number of WWH eligible for cervical cancer screening (defined as individuals aged 25 years and older with a cervix) and to assess their cervical cancer screening, follow-up and treatment history between September 1, 2022 and August 31, 2025. There is a waiver of consent for this medical record abstraction, and up to 2,500 records from Georgia and 1,000 records from Maryland will be extracted. Data collected will quantify screening eligibility, screening completion, abnormal results, follow-up procedures (including colposcopy), and treatment to identify gaps across the screening continuum.

This clinical trials record includes Aim 1b and Aim 2 since Aim 1a is retrospective chart review.

This clinical trials registration record represent Aim 1b and Aim 2 since Aim 1a is retrospective chart review. Aim 1b will consist of in-depth qualitative interviews with WWH identified through provider referral or response to clinic- or community-based fliers. Interviews will explore barriers and facilitators to cervical cancer screening and follow-up care and assess perspectives on how different HPV self-collection approaches could improve adherence and inform future guidelines. Participants will be stratified into three groups:

Group 1 will include WWH from participating clinical sites with a history of abnormal screening who were screened according to national guidelines (up to 5 per clinic, up to 20 total), including at least one individual who underwent colposcopy and at least two per clinic who did not complete recommended follow-up colposcopy or treatment after abnormal results; Group 2 will include WWH from participating clinical sites who have not been screened according to national guidelines (up to 5 per clinic, up to 20 total) ), including a minimum of 1 individual who underwent colposcopy and 2 individuals from each clinic who have not engaged in follow-up colposcopy or treatment after abnormal screening results.

Group 3 will include WWH recruited from community locations who are overdue for screening and have not been screened according to national guidelines (up to 10 WWH in Georgia and up to 5 in Maryland up to 15 total). The total number of IDIs will be up to 55.

Aim 2 will use the Plan-Do-Study-Act (PDSA) quality improvement framework to plan for implementation of an HPV self-collection intervention among WWH within participating Infectious Disease clinics in Georgia and Maryland. Focus groups will be conducted with multidisciplinary health care providers caring for WWH to identify clinical workflow challenges, access barriers, and health system constraints related to existing cervical cancer screening and follow-up protocols and to inform development of an implementation strategy for HPV self-collection. Using the iterative PDSA process-planning a change, testing it on a small scale, studying results, and refining or adapting the approach-findings from Aims 1 and 2 will inform the development of a future Type II hybrid effectiveness-implementation trial that will pilot implementation strategies while simultaneously collecting preliminary effectiveness data on HPV self-collection. The long-term objective is to improve cervical cancer screening uptake and timely follow-up among WWH in Infectious Disease clinic settings. The total number of participants in the focus groups will be up to 48.

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University SOM Division/Department: Gynecology & Obstetrics
        • Contact:
        • Principal Investigator:
          • Lisa Flowers, MD, MPH
        • Principal Investigator:
          • Anandi Sheth, MD, MSc
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine Division of Family and Community Medicine
        • Contact:
        • Principal Investigator:
          • Gregory Taylor, MD
        • Principal Investigator:
          • Clement Adebamowo, ScD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Aim 1b: In-depth interviews of Women with HIV : Women with Human Immunodeficiency Virus (HIV) who receive care will be interviewed at four clinical locations: the University of Maryland School of Medicine in Baltimore, MD; or the Ponce de Leon Clinic at Emory University in Atlanta, GA; Positive Impact Clinic in Atlanta, GA; and Albany Area Primary Health Care in Albany, GA. Women with HIV will also be recruited in the community in both Georgia and Maryland.

Aim 2: Focus groups of clinical providers: Clinical team members who work and provide care to women living with HIV at three clinical locations: the Center for Infectious Diseases (CID) at the University of Maryland School of Medicine in Baltimore, MD; Ponce de Leon Clinic at Emory University in Atlanta, GA; and Albany Area Primary Health Care in Albany, GA.

Description

Aim 1b Inclusion Criteria

  • women with Human Immunodeficiency Virus (HIV) receive care
  • ages between 25- 49
  • eligible for cervical cancer screening per national US guidelines

Aim 1b Exclusion Criteria • Women without an intact cervix.

Aim 2 Inclusion Criteria:

  • Clinical team members who work and provide care to women living with HIV at three clinical locations: the Center for Infectious Diseases (CID) at the University of Maryland School of Medicine in Baltimore, MD; Ponce de Leon Clinic at Emory University in Atlanta, GA; and Albany Area Primary Health Care in Albany, GA. a
  • Clinical team members will include: providers (Physicians, Nurse practitioners, Physician's Assistants, Nurses, Nursing Assistants, Medical Assistants, Pharmacists), laboratory members, or other staff involved in clinic operations.

Aim 2 Exclusion Criteria

• Individuals who do not work for the Center for Infectious Diseases (CID) at the University of Maryland School of Medicine in Baltimore, MD or the Ponce de Leon Clinic at Emory University in Atlanta, GA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with Human Immunodeficiency Virus (HIV)
Women with Human Immunodeficiency Virus (HIV) are eligible for cervical cancer screening and/or receiving care.
Behavioral: Qualitative interviews
In-depth qualitative interviews will be conducted with women with Human Immunodeficiency Virus (HIV) receiving care to explore barriers and facilitators to cervical cancer screening and follow-up care.
Healthcare providers
Healthcare providers (e.g. physicians, nurse practitioners, physician's assistants, nurses, nursing assistants, medical assistants, pharmacists), laboratory members, and IT Specialist/Medical Records Experts providing care to WWH.
Behavioral: Focus groups
Focus groups will be conducted with multidisciplinary care team members to assess perceived clinical workflow challenges, access barriers, and health system constraints related to current cervical cancer screening and follow-up protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barriers and facilitators to cervical cancer screening and follow-up among women with HIV
Time Frame: Baseline
Themes identified through semi-structured qualitative interviews assessing women with Human Immunodeficiency Virus (HIV) receiving care -reported barriers and facilitators to cervical cancer screening, adherence to follow-up care (including colposcopy and treatment), and perceptions of HPV self-collection approaches to improve screening uptake.
Baseline
Operational and logistical challenges that affect cervical cancer screening adherence and uptake of HPV self-testing
Time Frame: Baseline and 1 month follow up
A University of North Carolina Chapel Hill Research Investigator will conduct in-depth interviews and the focus group discussions with clinical providers at Maryland and Georgia Clinical Sites for Aims 1b and 2. In Aim 1a, UNC will receive partially de-identified medical record data from the Clinical Sites to analyze data to evaluate cervical cancer screening cascade completion among women with Human Immunodeficiency Virus (HIV).
Baseline and 1 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Director: Michael Hudgens, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Lisa Flowers, MD, MPH, Emory University
  • Study Chair: Jennifer S Smith, PhD, University of North Carolina, Chapel Hill
  • Study Chair: Lisa Rahangdale, MD, MPH, University of North Carolina, Chapel Hill
  • Principal Investigator: Clement S Adebamowo, ScD, University of Maryland SOM
  • Principal Investigator: Gregory Taylor, MD, University of Maryland SOM
  • Principal Investigator: Anandi Sheth, MD, MSc, Emory University
  • Study Director: Katie Mollan, PhD, University of North Carolina, Chapel Hill
  • Study Director: Vikrant Sahasrabuddhe, MBBS, MPH, DrPH, Division of Cancer Prevention (DCP), NCI
  • Study Director: Laura Gaydos, PhD, Emory University
  • Study Director: Patrick Ryscavage, MD, University of Maryland SOM
  • Study Director: Sue Siminski, Frontier Science Foundation
  • Study Director: Kayla Denson, Frontier Science Foundation
  • Study Director: Nicole Freitag, Frontier Science Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-1254
  • U24CA275417 (U.S. NIH Grant/Contract)
  • UG1CA275403 (U.S. NIH Grant/Contract)
  • UG1CA284884 (U.S. NIH Grant/Contract)
  • UG1CA284883 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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