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Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap

Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03317470
Enrollment
96
Registered
2017-10-23
Start date
2017-08-29
Completion date
2018-12-09
Last updated
2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Pap Smear, Colposcopy

Brief summary

The investigators aim to improve adherence to follow-up recommendations for an abnormal Pap and effectively reduce disparities in cervical cancer risk and disease among rural and low-income urban women.

Interventions

-11 questions about food security, housing personal safety, neighborhood safety, childcare, and transportation

BEHAVIORALLife Navigator

* The life navigator will contact women identified with unmet basic needs within two business days of completing the baseline survey. * The life navigator in our study will: (1) identify and assess women's needs; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help women access available resources by scheduling appointments and provide appointment reminders; (8) prepare women to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.

-5 questions about the acceptability of the basic needs survey

OTHERFollow-up survey (phase II participants only)

-7 questions about the effectiveness of the life navigator

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Newly referred patients to colposcopy clinic at SIUM and WUSM * Aged 18 years or older * English speaking * Able to provide verbal consent * Diagnosis of abnormal pap will be confirmed by pathology report * Member of all races and ethnic groups

Exclusion criteria

* Male * Established colposcopy clinic patients * Known diagnosis of cancer * Pregnancy * Incarcerated * Unable to consent * No access to a working contact phone number

Design outcomes

Primary

MeasureTime frameDescription
Participant adherence to initial colposcopy visitAt the time of initial colposcopy visit-Will use weekly clinic schedules to track adherence rates

Secondary

MeasureTime frameDescription
Number of unmet basic needs-2 weeks prior to initial colposcopy visits-Data obtained from Basic Needs Survey
Type of unmet basic needs-2 weeks prior to initial colposcopy visits-Data obtained from Basic Needs Survey
Participant adherence to recommended follow-up after initial colposcopy visitAt the time of initial colposcopy visit-Data will be collected for each participant to notate whether participant showed up for recommended follow-up visit and will be tabulated for all participants
Participant acceptability of the unmet basic needs surveyAt the time of initial colposcopy visit
Participant perception of effectiveness of life navigator to assist with their unmet basic needsAt the time of initial colposcopy visit* Data collected on the follow-up survey * 7 questions asking the following * Was the patient navigator helpful (yes with comments/no) * What could the navigator done better (multiple choice and area to add comments) * Did you use any of the resources the navigator told you about (yes with comments/no) * Would you recommend this type of helper to a family member or friend (yes/no) * Were there parts you didn't like or didn't find helpful (yes with comments/no) * Do you think the patient navigator helped you get to your clinic appointments (yes/no) * If available, would you find it helpful to talk to the patient navigator more (yes/no)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026