Human Immunodeficiency Virus (HIV)CASCADE3002NCT07520188
C-3002: Enhancing Cervical Cancer Screening Access and Follow-up Care at 'CASCADE' Clinical Sites in the United States
An observational study of Human Immunodeficiency Virus (HIV) and Human Papillomavirus (HPV), run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Human Papillomavirus (HPV), Cervical Cancer
- What is being tested?
- Qualitative interviews and Focus groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2026to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Aim 1a- Retrospective Chart Review 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Emory University SOM Division/Department: Gynecology & Obstetrics
Atlanta, Georgia, 30303
Lisa Flowers, MD, MPH, 404-251-8931, lflowe2@emory.edu
Lisa Flowers, MD, MPH
University of Maryland School of Medicine Division of Family and Community Medicine
Baltimore, Maryland, 21201
Gregory Taylor, MD, 410-225-8369, gtaylor@som.umaryland.edu
Gregory Taylor, MD
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus (HIV), Human Papillomavirus (HPV), Cervical Cancer, Cervical Precancer
- Being tested
- Qualitative interviews, Focus groups
- Keywords
- screening
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviewsBehavioural
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.
Focus groupsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Women with Human Immunodeficiency Virus (HIV) | Women with Human Immunodeficiency Virus (HIV) are eligible for cervical cancer screening. Receives: 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. Receives: Behavioral: Focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
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).
Measured: Baseline and 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start10 Nov 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer S Smith, PhD, Study chair, University of North Carolina, Chapel HillLisa Rahangdale, MD, MPH, Study chair, University of North Carolina, Chapel HillClement S Adebamowo, ScD, Principal investigator, University of Maryland SOMGregory Taylor, MD, Principal investigator, University of Maryland SOMLisa Flowers, MD, MPH, Principal investigator, Emory UniversityAnandi Sheth, MD, MSc, Principal investigator, Emory UniversityMichael Hudgens, PhD, Study director, University of North Carolina, Chapel HillKatie Mollan, PhD, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520188
- Sponsor's protocol ID
- 25-1254
- Other IDs
- UG1CA275403, UG1CA284884, UG1CA284883, U24CA275417
- Acronym
- CASCADE3002
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-3002: Enhancing Cervical Cancer Screening Access and Follow-up Care at 'CASCADE' Clinical Sites in the United States
- ClinicalTrials.gov ID
- NCT07520188
- Acronym / sponsor ID
- CASCADE3002 / 25-1254
- Conditions
- Human Immunodeficiency Virus (HIV), Human Papillomavirus (HPV), Cervical Cancer, Cervical Precancer
- Keywords
- screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with Human Immunodeficiency Virus (HIV) | – | Behavioral: Qualitative interviewsWomen with Human Immunodeficiency Virus (HIV) are eligible for cervical cancer screening. |
| Healthcare providers | – | Behavioral: Focus groupsHealthcare 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative interviewsIn-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. | Behavioural | Women with Human Immunodeficiency Virus (HIV) |
| Focus groupsFocus 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. | Behavioural | Healthcare providers |
Primary outcome
Determination of the Cervical Cancer Screening Cascade
Time frame: Baseline
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.
2 secondary outcomes
Barriers and facilitators to cervical cancer screening and follow-up among women with HIV
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer S Smith, PhD study chair
University of North Carolina, Chapel Hill
Lisa Rahangdale, MD, MPH study chair
University of North Carolina, Chapel Hill
Clement S Adebamowo, ScD principal investigator
University of Maryland SOM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV) and Human Papillomavirus (HPV), run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer S Smith, PhD (919-966-4432, jennifers@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the Cervical Cancer Screening Cascade (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.