Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age25-65
SponsorUniversity of Florida

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Using the American Cancer Society (ACS) screening recommendations, adults 25 to 65 will be eligible.

Assigned sex at birth is female

No previous history of cervical cancer

No previous history of a hysterectomy

Disqualifiers

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.

Trial population

Adults age 25 to 65 years old whose assigned sex at birth is female.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Participant Choice of HPV Self-Test

    Behavioral

    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

    Behavioral

    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

    Behavioral

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

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Standard of Care in-clinic Pap-Test2 interventions
Group B: HPV Self-Test2 interventions

Trial outcomes

Primary outcomes

1

Adherence to steps in the cervical cancer screening continuum

For the HPV self-testing group, 1. HPV test returned (Yes or No) 2. Results obtained (Yes or No) 3. Follow-up Pap test completed among those who tested positive for HPV (Yes or No) 4. Follow-up colposcopy completed among those who had positive Pap test (Yes or No) For the in-clinic testing group, 1\. In-clinic Pap test completed (Yes or No) 2. Results Obtained (Yes or No) 3. Follow-up colposcopy completed among those who had positive Pap test (Yes or No)

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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