Recruiting

Cervical Cancer Screening

Sponsor:

Mayo Clinic

Code:

NCT07890402

Conditions

Cervical Carcinoma

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

Interventions

HPV Self-Collection

Informational Intervention

Interview

Survey Administration

Receive screening results

Study Details

Brief 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 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

Study ID

NCT07890402

Start date

Aug 15, 2026

Status verified date

Oct, 2026

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Aug 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Females self-identifying as belonging to the Hispanic or East African immigrant community
  • Ages 30-65 years
  • Intact uterus

Exclusion Criteria:

  • 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
  • Current pregnancy or post-partum in the last 3 months
  • Positive HIV status
  • Immunocompromise
  • Use of vaginal products within 2 days of appointment

Study Design

Enrollment

118 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Screening (community-based CCS)

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.

Interventions

HPV Self-Collection

Complete self-collection of vaginal HPV sample alone or with clinician assistance

Informational Intervention

Receive written and video self-collection instructions

Interview

Participants will be asked to take part in a brief interview to learn about their experience in the clinic and suggestions for improvement

Survey Administration

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 results

Receive testing results

Receive recommended steps following abnormal results

Receive recommended next steps and primary care team communication

Telephone-Based Intervention

May receive verification phone call

Primary outcome measure

  • Number of individuals screened in the community via this protocol [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Jissy Cyriac, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.