About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
women with Human Immunodeficiency Virus (HIV) receive care
ages between 25- 49
eligible for cervical cancer screening per national US guidelines
Disqualifiers
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.
Trial population
Aim 1a- Medical health records of patients living with HIV. 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Qualitative interviews
BehavioralIn-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.
Focus groups
BehavioralFocus 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.
Treatment groups
Trial outcomes
Primary outcomes
Determination of the Cervical Cancer Screening Cascade
The cervical cancer screening cascade will be documented among screen-eligible patients in Infectious Disease HIV care clinics associated with US-based 'CASCADE' Clinical Sites (CS4 Georgia (GA) and CS8 Maryland (MD)) by constructing a cohort via retrospective chart review.
Secondary outcomes
Barriers and facilitators to cervical cancer screening and follow-up among women with HIV
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.
Operational and logistical challenges that affect cervical cancer screening adherence and uptake of HPV self-testing
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).
Sponsors and contacts
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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