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 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.

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

Aim 1a and Aim1 b includes only women and Aim 2 will include women and men.

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.