Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: patient navigation and self-collection.
- Who it may be relevant to
- Registry conditions: Diabetes, Cervical Cancer (Early Detection), Obesity & Overweight. Basic parameters: from 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. Aim 3: Assess the Feasibility and Acceptability of the PINPOINT Intervention.
Overview
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.
Interventions
- Behavioral patient navigation and self-collection
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.
Primary outcome measures
- Cervical cancer screening [Time frame: within 6 months]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
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)
- 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).
Exclusion criteria
- Previous history of cervical cancer
- Total hysterectomy
- Pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- UF Health Internal Medicine — Gainesville
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. PMID 35264120
- Mkuu 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 PMID 41467104
- Mkuu 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. PMID 38444842
Identifiers
NCT: NCT07351110 · IRB202500780 · 1K01CA292583-01