Cervical Cancer Screening MethodsNCT05390567
Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women
An observational study of Cervical Cancer Screening Methods, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening Methods
- What is being tested?
- Participant Choice of HPV Self-Test and Survey: Participant cancer history and cervical cancer prevention/screening knowledge
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults age 25 to 65 years old whose assigned sex at birth is female.
Who may be able to join
- 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
- Not currently pregnant (self-report)
- Not currently menstruating*
Show all 12Show fewer
- 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.
- Have not given birth in the prior 12 weeks*
- 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.
- 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
- Reside in census tracts where the Mobile Outreach Clinic travels.
- Have a mobile phone or access to a mobile phone that can be used to receive messages or a valid email address.
Who cannot join
- 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 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
University of Florida
Gainesville, Florida, 32610
Jennifer Woodard, RN, MPH, 352-259-5574, jenwoodard@ufl.edu
About this study
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).
Read the detailed description
The purpose of this pilot project is to gather information about the extent to which women residing in high SEV neighborhoods who choose HPV self-sampling relative to in-clinic Pap/HPV testing adhere to the cancer screening continuum steps, for which they are eligible. The women will self-select into HPV self-sampling versus in-clinic Pap/HPV testing combined with follow-up telephone calls and text messages from community clinical navigators and CHWs.
The research components of this study involve: 1) offering women the opportunity to complete the HPV self-test in a non-clinical setting to be returned via a mailer or handed to the community clinical navigator or CHW and 2) asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening. All other components of this study are part of clinical care. All other planned activities align with clinically based recommendations and guidelines (e.g., follow-up for colposcopy for + Paps)
- Conditions
- Cervical Cancer Screening Methods
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant Choice of HPV Self-TestBehavioural
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 knowledgeBehavioural
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-testBehavioural
Participant choice of cervical cancer screening method with either a SOC in-clinic pap test or HPV self-test
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care in-clinic Pap-Test | Participant cervical cancer screening method of choice: Standard of Care Pap-Test Receives: Behavioral: Survey: Participant cancer history and cervical cancer prevention/screening knowledge; Behavioral: Participant Choice of Standard of Care in-clinic Pap-test | |
| HPV Self-Test | Participant cervical cancer screening method of choice: HPV Self-Test Receives: Behavioral: Participant Choice of HPV Self-Test; Behavioral: Survey: Participant cancer history and cervical cancer prevention/screening knowledge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to steps in the cervical cancer screening continuum
For the HPV self-testing group,
- HPV test returned (Yes or No)
- Results obtained (Yes or No)
- Follow-up Pap test completed among those who tested positive for HPV (Yes or No)
- Follow-up colposcopy completed among those who had positive Pap test (Yes or No) For the in-clinic testing group,
- 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start7 Jun 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Screening MethodsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramzi A Salloum, PhD, Principal investigator, Division Director, Department of Health Outcomes and Biomedical Informatics, University of Florida; Associate Director, Office of Community Outreach and Engagement, UFHealth Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390567
- Sponsor's protocol ID
- IRB202200613
- Other IDs
- OCR41931
- Status last verified
- Aug 2026
- First submitted
- 19 May 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women
- ClinicalTrials.gov ID
- NCT05390567
- Acronym / sponsor ID
- IRB202200613
- Conditions
- Cervical Cancer Screening Methods
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The purpose of this pilot project is to gather information about the extent to which women residing in high SEV neighborhoods who choose HPV self-sampling relative to in-clinic Pap/HPV testing adhere to the cancer screening continuum steps, for which they are eligible. The women will self-select into HPV self-sampling versus in-clinic Pap/HPV testing combined with follow-up telephone calls and text messages from community clinical navigators and CHWs.
The research components of this study involve: 1) offering women the opportunity to complete the HPV self-test in a non-clinical setting to be returned via a mailer or handed to the community clinical navigator or CHW and 2) asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening. All other components of this study are part of clinical care. All other planned activities align with clinically based recommendations and guidelines (e.g., follow-up for colposcopy for + Paps)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care in-clinic Pap-Test | – | Behavioral: Survey: Participant cancer history and cervical cancer prevention/screening knowledge, Behavioral: Participant Choice of Standard of Care in-clinic Pap-testParticipant cervical cancer screening method of choice: Standard of Care Pap-Test |
| HPV Self-Test | – | Behavioral: Participant Choice of HPV Self-Test, Behavioral: Survey: Participant cancer history and cervical cancer prevention/screening knowledgeParticipant cervical cancer screening method of choice: HPV Self-Test |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults age 25 to 65 years old whose assigned sex at birth is female.
Key inclusion criteria (12 listed)
- 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
- Not currently pregnant (self-report)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant Choice of HPV Self-TestOpportunity for participants to complete the HPV self-test in a non-clinical setting to be returned via a mailer or courier servie. | Behavioural | HPV Self-Test |
| Survey: Participant cancer history and cervical cancer prevention/screening knowledgeAsking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening. | Behavioural | HPV Self-Test, Standard of Care in-clinic Pap-Test |
| Participant Choice of Standard of Care in-clinic Pap-testParticipant choice of cervical cancer screening method with either a SOC in-clinic pap test or HPV self-test | Behavioural | Standard of Care in-clinic Pap-Test |
Primary outcome
Adherence to steps in the cervical cancer screening continuum
Time frame: 6 months
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramzi A Salloum, PhD principal investigator
Division Director, Department of Health Outcomes and Biomedical Informatics, University of Florida; Associate Director, Office of Community Outreach and Engagement, UFHealth Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Screening Methods, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Barrow, MHA, CCRP (352-3253703, jamiehensley@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to steps in the cervical cancer screening continuum (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.