Recruiting

Cancer Screening

Sponsor:

University of Florida

Code:

NCT05390567

Conditions

Cervical Cancer Screening Methods

Eligibility Criteria

Sex: Female

Age: 25 - 65

Healthy Volunteers: Accepted

Interventions

Participant Choice of HPV Self-Test

Survey: Participant cancer history and cervical cancer prevention/screening knowledge

Participant Choice of Standard of Care in-clinic Pap-test

Study Details

Brief summary:

Project CONTINUITY (Connecting You to Care in the Community) was developed to increase adherence to cervical cancer screening regimens from initial screening to needed follow-up care by (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method (Pap/HPV co-testing vs. HPV self-test collection), community clinical navigators and community health workers (CHWs), customized messages and support for patient portal access for test results and (2) implementing strategies to address social determinants of health (SDoH) that may influence an individual's ability to adhere to the screening regimen, with an initial focus on removing transportation barriers through the use of a mobile outreach clinics (MOC).

Conditions

Cervical Cancer Screening Methods

Study ID

NCT05390567

Start date

Jun 7, 2024

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Using the American Cancer Society (ACS) screening recommendations, adults 25 to 65 will be eligible.
2. Assigned sex at birth is female
3. No previous history of cervical cancer
4. No previous history of a hysterectomy
5. Not currently pregnant (self-report)
6. Not currently menstruating\*
7. Have not used any vaginal products (e.g., oil-based lubricants, antifungal, and douches) in prior 2 days\*. Use of vaginal contraceptives, condoms and water-based lubricants are allowed.
8. Have not given birth in the prior 12 weeks\*
9. Self-report they have not undergone cancer screening in the past 4 years or more OR report being past due according to provider recommended screening schedule.
10. Self-report of using the MOC in the past, no current usual source of care OR usual source of care is a non-UFH provider and/or cervical cancer screening is not accessible through that provider
11. Reside in census tracts where the Mobile Outreach Clinic travels.
12. Have a mobile phone or access to a mobile phone that can be used to receive messages or a valid email address.

Exclusion Criteria:

  • For patients who are excluded for criterion 6, 7, and 8, the outreach team (community clinical navigator and CHW) will ask the participant if they can be re-contacted for potential future study eligibility assessment. If the participant agrees, the navigator or CHW will collect contact information to re-contact the participant at a later (pre-determined) date up to 20 weeks later for eligibility screening.

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

Standard of Care in-clinic Pap-Test

Participant cervical cancer screening method of choice: Standard of Care Pap-Test

HPV Self-Test

Participant cervical cancer screening method of choice: HPV Self-Test

Interventions

Participant Choice of HPV Self-Test

Opportunity for participants to complete the HPV self-test in a non-clinical setting to be returned via a mailer or courier servie.

Survey: Participant cancer history and cervical cancer prevention/screening knowledge

Asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening.

Participant Choice of Standard of Care in-clinic Pap-test

Participant choice of cervical cancer screening method with either a SOC in-clinic pap test or HPV self-test

Primary outcome measure

  • Adherence to steps in the cervical cancer screening continuum [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jamie Barrow, MHA, CCRP

352-3253703jamiehensley@ufl.edu

Jennifer N Woodard, MPH, CCRP

352-294-5974jenwoodard@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Jennifer Woodard, RN, MPH

352-259-5574jenwoodard@ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.