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RecruitingNCT07890402Updated Oct 22, 2026

A Community Based Intervention to Improve Cervical Cancer Screening Among Women in the Hispanic and East African Immigrant Community

An interventional study of HPV Self-Collection and Informational Intervention in Cervical Carcinoma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Not applicable
Ages
30 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cervical Carcinoma
03

In context

Uterine Cervical Neoplasms

1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.

This study's planned enrollment of 118 is above the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
118 participants (estimated)

Study 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.

    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

Interventions

  • ProcedureHPV Self-Collection

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

    Also known as: Human Papillomavirus Self-Collection

  • OtherInformational Intervention

    Receive written and video self-collection instructions

  • OtherInterview

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

  • OtherSurvey Administration

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

  • ProcedureReceive screening results

    Receive testing results

    Also known as: receive test results

  • ProcedureReceive recommended steps following abnormal results

    Receive recommended next steps and primary care team communication

  • BehavioralTelephone-Based Intervention

    May receive verification phone call

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 1 year

Secondary outcomes

  1. 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.

    Time frame: Up to 28 days

  2. 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.

    Time frame: Up to 3 months

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    Recruiting
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.

Of 395 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 71. This study's planned 12 months is below that.

Counting every sponsor, half of 409 studies reached it within 33 months; a quarter within 15 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2026
First posted
Oct 22, 2026
StartActual
Aug 15, 2026
Primary completionEst.
Aug 15, 2027
CompletionEst.
Aug 15, 2027
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07890402
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Aug 15, 2026
Primary completion
Aug 15, 2027 (estimated)
Completion
Aug 15, 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Jissy Cyriac, MD
principal investigator · Mayo Clinic in Rochester

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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