Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate
NCT ID: NCT05458960
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2025-03-28
2025-11-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm 1: Social needs navigator program
Participants will be paired with a community health worker who will provide tailored support to address unmet social needs. The number and frequency of calls will be limited only by participants' needs, interest, and willingness to interact. The type of contact could include phone calls, or home/community visits. The community health worker will: (1) identify and assess patients' unmet social needs; (2) jointly generate solutions; (3) help prioritize among multiple needs; (4) identify community resources that could help resolve the problem(s); (5) determine eligibility for services; (6) help patients access available resources by scheduling appointments and providing appointment reminders; (7) prepare patients to interact with service agencies and/or act as an advocate; (8) provide support such as arranging transportation; (9) oversee follow-up problem-solving actions; and (10) review progress made towards resolving unmet social needs and adapt solutions.
Social needs navigator program
4 months of assistance tailored to the needs of the participant
Arm 2: Enhanced usual care
Participants will receive verbal referral to a federally funded, free, 24-hr assistance hotline, United Way 2-1-1, which connects callers with community services to help address unmet social needs.
Enhanced usual care
Referral to United Way 2-1-1
Arm 3: Clinic provider
4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.
No interventions assigned to this group
Interventions
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Social needs navigator program
4 months of assistance tailored to the needs of the participant
Enhanced usual care
Referral to United Way 2-1-1
Eligibility Criteria
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Inclusion Criteria
* Missed appointment at BJH colposcopy clinic and need to reschedule
* Age 21 years or older
* Able to provide verbal consent
* Diagnosis of an abnormal cervical screen confirmed by cytology or pathology
Exclusion Criteria
* Known diagnosis or history of cancer
* Unable to consent
21 Years
90 Years
FEMALE
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Lindsay M Kuroki, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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202205183
Identifier Type: -
Identifier Source: org_study_id