DiabetesPINPOINTNCT07351110
Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions.
A study testing patient navigation and self-collection in people with Diabetes and Cervical Cancer (Early Detection), run by University of Florida at 1 site in United States.
Trial summary
Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Cervical Cancer (Early Detection), Obesity & Overweight
- What is being tested?
- patient navigation and self-collection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2026to 31 Mar 2028
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The following eligibility criteria will be used to determine inclusion into the study:
- Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible
- Active UF Internal Medicine patient and has had an appointment in the last 2 months.
- Assigned sex at birth is female
- Have Obesity or Type 2 Diabetes
- Not currently pregnant (self-report)
Show all 13Show fewer
- Have not given birth in the prior 12 weeks
- No previous history of cervical cancer
- No previous history of a hysterectomy
- Have not undergone cancer screening in the past 3 years or more
- Reside in the UFHCI Catchment Area (Alachua, Baker, Bradford, Citrus, Clay, Columbia, Dixie, Gadsden, Gilchrist, Hamilton, Jefferson, Lafayette, Lake, Leon, Levy, Madison, Marion, Putnam, Sumter, Suwannee, Taylor, UnioF1n, or Wakulla County).
- Have a mobile phone or access to a mobile phone that can be used to receive messages, or a valid email address.
- Are not currently scheduled to receive cervical cancer screening via clinician sampling (pap smear).
Who cannot join
- Previous history of cervical cancer
- Total hysterectomy
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniela Rivero-Mendoza, MS. contact
United States1 site, 1 recruiting
- Recruiting
UF Health Internal Medicine
Gainesville, Florida, 32611
Dianne G Goede, MD, 352-265-0140, diannelroberts@ufl.edu
Dianne L Goede, MD
About this study
Official title: Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. Aim 3: Assess the Feasibility and Acceptability of the PINPOINT Intervention.
Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer.
Read the detailed description
We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer. We will use the six steps of the Intervention Mapping approach to guide the process of testing the intervention. This project aligns with the current efforts at the University of Florida Health Cancer Institute (UFHCI) and UF Health Internal Medicine to improve cervical cancer screening rates among under-screened women. We will partner with these efforts to test the PINPOINT intervention. Project CONTINUITY (Connecting You to Care in the Community) at UFHCI, Office of Community Outreach and Engagement (COE), is working to increase adherence to cervical screening and follow-up by; (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method, community clinical navigators (CCN) and community health workers (CHWs), customized messages and support for patient portal access for test results, and (2) implementing strategies to address non-medical drivers that may influence an individual's ability to adhere to the screening, with an initial focus on removing transportation barriers through the use of a mobile outreach clinic (MOC).
Currently, a patient navigator supervised by Dr. Dianne Goede identifies patients who have an upcoming office visit and are due for cervical cancer screening at UF Health Internal Medicine. The patient navigator outreaches the patient, reminds them of their overdue status for cervical cancer screening and the importance of cervical cancer screening, and inquires if they are agreeable to complete screening at the scheduled office visit. We will reach out to patients who remain unscreened for cervical cancer 2 months after their scheduled visit with UF Health Internal Medicine. We will obtain a list of patients from the UF Health Consent2Share database. Patients who agree to participate in our study will be randomized to either receive the PINPOINT intervention (self-collection test with patient navigation) or standard of care (reminder to screen from UF Health Internal Medicine). We will use the sealed envelope randomization method to assign participants to either treatment or control groups right after intake.
We will pilot the PINPOINT intervention at UF Internal Medicine clinics and use Proctor's Framework for Implementation Outcomes to evaluate the intervention. Changes will be made to the intervention protocol and tested in a future randomized trial with a larger sample. Hypothesis: PINPOINT will meet the needs of women living with socioeconomic challenges, T2D, and obesity, and will align with the clinical workflow. PINPOINT will be appropriate, feasible and acceptable.27 Outcome: The PINPOINT intervention will have positive outcomes in terms of feasibility and acceptability among patients.
- Being tested
- patient navigation and self-collection
- Keywords
- cervical cancer screening, self-collection, self-sampling
- Medical subject headings
- Diabetes Mellitus, Uterine Cervical Neoplasms, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient navigation and self-collectionBehavioural
Also called self-collection, self-sampling, patient navigation
Patients will receive a combination of patient navigation, education, and cervical cancer self-collection sampling as part of the intervention to support cervical cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | PINPOINT intervention arm will entail assigning patients to a patient navigator to assist them with screening reminders and address any barriers they have to screening, education on cervical cancer screening, and patients will also be offered the opportunity to self-collect their sample for cervical cancer screening. Receives: Behavioral: patient navigation and self-collection |
| Control Arm | No intervention | No intervention arm, patients will receive reminders for screening according to current clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical cancer screening
receiving cervical cancer screening either via self-collection, pap smear, or hpv testing
Measured: within 6 months
Secondary outcomes (3)
Acceptability
How agreeable or satisfactory participants find the intervention or implementation strategy. Questions include, HPV Self-Collection meets my approval, HPV Self-Collection is appealing to me, I like HPV Self-Collection, and I welcome HPV Self-Collection. Participants will fill a 4 point likert scale for each, (completely disagree, disagree, neither agree not disagree, agree, completely agree).
Measured: from enrollment until they complete screening or at the end of the trial at 6 months
Appropriateness
The perceived fit or compatibility of the intervention for a specific setting, provider, or consumer, or to address a problem. Questions include, HPV Self-Collection seems fitting, HPV Self-Collection seems suitable, HPV Self-Collection seems applicable., and HPV Self-Collection seems like a good match. Participants will fill a 4 point likert scale for each, (completely disagree, disagree, neither agree not disagree, agree, completely agree).
Measured: from enrollment until they complete screening or at the end of the trial at 6 months
Feasibility measure
- The extent to which an intervention can be successfully used in a given setting. Questions include, HPV Self-Collection seems implementable, HPV Self-Collection seems possible, HPV Self-Collection seems doable, and HPV Self-Collection seems easy to use. Participants will fill a 4 point likert scale for each, (completely disagree, disagree, neither agree not disagree, agree, completely agree).
Measured: from enrollment until they complete screening or at the end of the trial at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start30 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351110
- Sponsor's protocol ID
- IRB202500780
- Other IDs
- 1K01CA292583-01
- Acronym
- PINPOINT
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mkuu RS, Staras SA, Szurek SM, D'Ingeo D, Gerend MA, Goede DL, Shenkman EA. Clinicians' perceptions of barriers to cervical cancer screening for women living with behavioral health conditions: a focus group study. BMC Cancer. 2022 Mar 9;22(1):252. doi: 10.1186/s12885-022-09350-5.
PubMed 35264120Mkuu RS, Tohme S, Rivero-Mendoza D, Salloum RG, Goede D, Bruggeman B, Nicholson K, Hall JM, Bylund C, Woodard JN, Hensley J, Shenkman EA, Donahoo WT, Mulugeta A, Hernandez M, Staras SA. Improving Patient Education Materials for HPV Self-Collection: Insights from Women at High Risk of Developing Cervical Cancer. Cancer Manag Res. 2025 Dec 24;17:3273-3284. doi: 10.2147/CMAR.S552282. eCollection 2025.
PubMed 41467104Mkuu RS, Staras SA, Chakrabarti C, Hall J, Harvey I, Salloum RG, Barrow S, Ortega S, Woodard J, Seals K, Rawls A, Meduri Y, Donahoo WT, Goede DL, Shenkman EA. Acceptability of HPV self-collection: A qualitative study of Black women living with type II diabetes and social vulnerability. J Clin Transl Endocrinol. 2024 Feb 25;35:100331. doi: 10.1016/j.jcte.2024.100331. eCollection 2024 Mar.
PubMed 38444842
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. Aim 3: Assess the Feasibility and Acceptability of the PINPOINT Intervention.
- ClinicalTrials.gov ID
- NCT07351110
- Acronym / sponsor ID
- PINPOINT / IRB202500780
- Keywords
- cervical cancer screening, self-collection, self-sampling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 20 Jan 2026 (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.
Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer.
Detailed description
We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer. We will use the six steps of the Intervention Mapping approach to guide the process of testing the intervention. This project aligns with the current efforts at the University of Florida Health Cancer Institute (UFHCI) and UF Health Internal Medicine to improve cervical cancer screening rates among under-screened women. We will partner with these efforts to test the PINPOINT intervention. Project CONTINUITY (Connecting You to Care in the Community) at UFHCI, Office of Community Outreach and Engagement (COE), is working to increase adherence to cervical screening and follow-up by; (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method, community clinical navigators (CCN) and community health workers (CHWs), customized messages and support for patient portal access for test results, and (2) implementing strategies to address non-medical drivers that may influence an individual's ability to adhere to the screening, with an initial focus on removing transportation barriers through the use of a mobile outreach clinic (MOC).
Currently, a patient navigator supervised by Dr. Dianne Goede identifies patients who have an upcoming office visit and are due for cervical cancer screening at UF Health Internal Medicine. The patient navigator outreaches the patient, reminds them of their overdue status for cervical cancer screening and the importance of cervical cancer screening, and inquires if they are agreeable to complete screening at the scheduled office visit. We will reach out to patients who remain unscreened for cervical cancer 2 months after their scheduled visit with UF Health Internal Medicine. We will obtain a list of patients from the UF Health Consent2Share database. Patients who agree to participate in our study will be randomized to either receive the PINPOINT intervention (self-collection test with patient navigation) or standard of care (reminder to screen from UF Health Internal Medicine). We will use the sealed envelope randomization method to assign participants to either treatment or control groups right after intake.
We will pilot the PINPOINT intervention at UF Internal Medicine clinics and use Proctor's Framework for Implementation Outcomes to evaluate the intervention. Changes will be made to the intervention protocol and tested in a future randomized trial with a larger sample. Hypothesis: PINPOINT will meet the needs of women living with socioeconomic challenges, T2D, and obesity, and will align with the clinical workflow. PINPOINT will be appropriate, feasible and acceptable.27 Outcome: The PINPOINT intervention will have positive outcomes in terms of feasibility and acceptability among patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: patient navigation and self-collectionPINPOINT intervention arm will entail assigning patients to a patient navigator to assist them with screening reminders and address any barriers they have to screening, education on cervical cancer screening, and patients will also be offered the opportunity to self-collect their sample for cervical cancer screening. |
| Control Arm | No intervention | –No intervention arm, patients will receive reminders for screening according to current clinical practice |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible
- Active UF Internal Medicine patient and has had an appointment in the last 2 months.
- Assigned sex at birth is female
- Have Obesity or Type 2 Diabetes
- Not currently pregnant (self-report)
Key exclusion criteria (3 listed)
- Previous history of cervical cancer
- Total hysterectomy
- Pregnant
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 |
|---|---|---|
| patient navigation and self-collectionAlso: self-collection, self-sampling, patient navigationPatients will receive a combination of patient navigation, education, and cervical cancer self-collection sampling as part of the intervention to support cervical cancer screening. | Behavioural | Intervention |
Primary outcome
Cervical cancer screening
Time frame: within 6 months
receiving cervical cancer screening either via self-collection, pap smear, or hpv testing
3 secondary outcomes
Acceptability
Time frame: from enrollment until they complete screening or at the end of the trial at 6 months
Appropriateness
Time frame: from enrollment until they complete screening or at the end of the trial at 6 months
Feasibility measure
Time frame: from enrollment until they complete screening or at the end of the trial at 6 months
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 10 Aug 2026.
- Background: PubMed 35264120Mkuu RS, Staras SA, Szurek SM, D'Ingeo D, Gerend MA, Goede DL, Shenkman EA. Clinicians' perceptions of barriers to cervical cancer screening for women living with behavioral health conditions: a focus group study. BMC Cancer. 2022 Mar 9;22(1):252. doi: 10.1186/s12885-022-09350-5.
- Background: PubMed 41467104Mkuu RS, Tohme S, Rivero-Mendoza D, Salloum RG, Goede D, Bruggeman B, Nicholson K, Hall JM, Bylund C, Woodard JN, Hensley J, Shenkman EA, Donahoo WT, Mulugeta A, Hernandez M, Staras SA. Improving Patient Education Materials for HPV Self-Collection: Insights from Women at High Risk of Developing Cervical Cancer. Cancer Manag Res. 2025 Dec 24;17:3273-3284. doi: 10.2147/CMAR.S552282. eCollection 2025.
- Background: PubMed 38444842Mkuu RS, Staras SA, Chakrabarti C, Hall J, Harvey I, Salloum RG, Barrow S, Ortega S, Woodard J, Seals K, Rawls A, Meduri Y, Donahoo WT, Goede DL, Shenkman EA. Acceptability of HPV self-collection: A qualitative study of Black women living with type II diabetes and social vulnerability. J Clin Transl Endocrinol. 2024 Feb 25;35:100331. doi: 10.1016/j.jcte.2024.100331. eCollection 2024 Mar.
- Study Funding InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Daniela Rivero-Mendoza, MS. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient navigation and self-collection in people with Diabetes and Cervical Cancer (Early Detection), 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 13 inclusion and 3 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 10 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 Rahma Mkuu, PhD ((352) 294-8419, rmkuu@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical cancer screening (time frame: within 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07351110, which also lists 3 linked publications.
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 10 Aug 2026.