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OpenTrials
Completed

NCT Number: NCT03317470

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

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.

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Key information

Conditions

Abnormal Pap Smear Colposcopy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basic needs survey

Other

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

Life Navigator

Behavioral
  • 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.

Follow-up survey

Other

-5 questions about the acceptability of the basic needs survey

Follow-up survey (phase II participants only)

Other

-7 questions about the effectiveness of the life navigator

Primary outcomes

  1. Participant adherence to initial colposcopy visit

    Time frame: At the time of initial colposcopy visit

    -Will use weekly clinic schedules to track adherence rates

Secondary outcomes

  1. Number of unmet basic needs

    Time frame: -2 weeks prior to initial colposcopy visits

    -Data obtained from Basic Needs Survey

  2. Type of unmet basic needs

    Time frame: -2 weeks prior to initial colposcopy visits

    -Data obtained from Basic Needs Survey

  3. Participant adherence to recommended follow-up after initial colposcopy visit

    Time frame: At 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

  4. Participant acceptability of the unmet basic needs survey

    Time frame: At the time of initial colposcopy visit

  5. Participant perception of effectiveness of life navigator to assist with their unmet basic needs

    Time frame: At 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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2017
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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