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

NCT07520188 | Not Yet Recruiting DMC

• 5 other identifiers: 25-1254UG1CA275403UG1CA284884UG1CA284883U24CA275417
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Human Papillomavirus (HPV); Cervical Precancer; Cervical Cancer; Human Immunodeficiency Virus (HIV)

Keywords

screening

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (2)

• Barriers and facilitators to cervical cancer screening and follow-up among women with HIV

  Baseline

• Operational and logistical challenges that affect cervical cancer screening adherence and uptake of HPV self-testing

  Baseline and 1 month follow up

Study Arms (2)

Women with Human Immunodeficiency Virus (HIV)

Women with Human Immunodeficiency Virus (HIV) are eligible for cervical cancer screening.

Behavioral: Qualitative interviews

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

Interventions

Qualitative interviews BEHAVIORAL

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.

Women with Human Immunodeficiency Virus (HIV)

Focus groups BEHAVIORAL

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.

Healthcare providers

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Aim 1a and Aim1 b includes only women and Aim 2 will include women and men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Emory University SOM Division/Department: Gynecology & Obstetrics

Atlanta, Georgia, 30303, United States

Location

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

Baltimore, Maryland, 21201, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jennifer S Smith, PhD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

• Lisa Rahangdale, MD, MPH

  University of North Carolina, Chapel Hill

  STUDY CHAIR

• Clement S Adebamowo, ScD

  University of Maryland SOM

  PRINCIPAL INVESTIGATOR

• Gregory Taylor, MD

  University of Maryland SOM

  PRINCIPAL INVESTIGATOR

• Lisa Flowers, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

• Anandi Sheth, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

• Michael Hudgens, PhD

  University of North Carolina, Chapel Hill

  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

  STUDY DIRECTOR

Central Study Contacts

Jennifer S Smith, PhD

CONTACT

919-966-4432; jennifers@unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

US (2)