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

Sponsored by UNC Lineberger Comprehensive Cancer Center

About this study

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.

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 wi…

Where this study is enrolling (2)

  • Emory University SOM Division/Department: Gynecology & Obstetrics

    Atlanta, Georgia

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  • University of Maryland School of Medicine Division of Family and Community Medicine

    Baltimore, Maryland

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Who can participate

Inclusion criteria

  • ✓Health records of WWH who are ages 25 and over, clients of the participating clinics, and eligible for cervical cancer screening per national US guidelines, during the time period of September 1, 2022 to August 31, 2025.
  • ✓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.
  • ✕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.

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Trial data sourced from ClinicalTrials.gov.