Cervical CarcinomaNCT07890402
A Community Based Intervention to Improve Cervical Cancer Screening Among Women in the Hispanic and East African Immigrant Community
A study testing HPV Self-Collection, Informational Intervention and Interview in people with Cervical Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial studies whether a community based intervention improves cervical cancer screening (CCS) among women in the Hispanic and East African immigrant community. Previous research has shown that CCS remains low among women of the Hispanic and East African immigrant community due to lack of awareness about… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- HPV Self-Collection, Informational Intervention and Interview
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 15 Aug 2027
- Phase
- Interventional
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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females self-identifying as belonging to the Hispanic or East African immigrant community
- Ages 30-65 years
- Intact uterus
Who cannot join
- Females who do not identify as belonging to the Hispanic or East African immigrant community
- Outside age range of 30-65 years
- Self reported history of
- Hysterectomy
- Cervical cancer
- Cervical cancer screening in the last 3 years
Show all 10Show fewer
- Current pregnancy or post-partum in the last 3 months
- Positive HIV status
- Immunocompromise
- Use of vaginal products within 2 days of appointment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Jissy Cyriac, MD
About this study
Official title: Improving Cervical Cancer Screening Among Populations Experiencing Health Disparities Via Community Based Intervention
This clinical trial studies whether a community based intervention improves cervical cancer screening (CCS) among women in the Hispanic and East African immigrant community. Previous research has shown that CCS remains low among women of the Hispanic and East African immigrant community due to lack of awareness about cervical cancer as well as recommended screening guidelines. The community based intervention in this trial will offer CCS in the Hispanic and East African immigrant community using a test that can be completed by the individual. The test uses a brush that is placed inside the vagina to collect a sample. The self-collected sample is then tested for a virus called human papillomavirus (HPV). Because some types of HPV can cause cervical cancer, checking for HPV, may lower a woman's chance of getting cervical cancer. A community based intervention may be an effective way to improve CCS among women in the Hispanic and East African immigrant community.
- Conditions
- Cervical Carcinoma
- Being tested
- HPV Self-Collection, Informational Intervention, Interview, Survey Administration, Receive screening results
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Self-CollectionProcedure or surgery
Also called Human Papillomavirus Self-Collection
Complete self-collection of vaginal HPV sample alone or with clinician assistance
Informational InterventionOther
Receive written and video self-collection instructions
InterviewOther
Participants will be asked to take part in a brief interview to learn about their experience in the clinic and suggestions for improvement
Survey AdministrationOther
Participants will be asked to take part in a brief survey to learn about their experience in the clinic and suggestions for improvement.
Receive screening resultsProcedure or surgery
Also called receive test results
Receive testing results
Receive recommended steps following abnormal resultsProcedure or surgery
Receive recommended next steps and primary care team communication
Telephone-Based InterventionBehavioural
May receive verification phone call
| Study group | Role | What they receive |
|---|---|---|
| Screening (community-based CCS) | Experimental | Participants receive written and video self-collection instructions and complete vaginal HPV sample collection using self-collection brush with or without clinician assistance during screening appointment. Participants then receive testing results via phone call and mailed letter. Participants with abnormal test results also receive recommended next steps as well as communication to primary care team on study. Approximately 14-28 days after screening appointment, participants receive a phone call to verify receipt of results and/or outcomes of abnormal testing result follow-up. Receives: Procedure: HPV Self-Collection; Other: Informational Intervention; Other: Interview; Other: Survey Administration; Procedure: Receive screening results; Procedure: Receive recommended steps following abnormal results; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals screened in the community via this protocol
Assessed by the number of participants who undergo cervical cancer screening. Results will be analyzed descriptively.
Measured: Up to 1 year
Secondary outcomes (2)
Number of abnormal screening results identified
Assessed by the number of participants who receive abnormal results such as positive HPV or invalid test result. Results will be analyzed descriptively.
Measured: Up to 28 days
Follow up completed
Assessed by the number of participants with abnormal screening results who obtained follow-up testing as recommended. Results will be analyzed descriptively.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 Aug 2026
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jissy Cyriac, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890402
- Sponsor's protocol ID
- 26-002024
- Other IDs
- NCI-2026-07178
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No