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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-29

Study Completion Date

2018-12-09

Brief Summary

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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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Detailed Description

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Conditions

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Abnormal Pap Smear Colposcopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Phase I:

* In Phase 1 of the study (first five months), the investigators will enroll new patients when they call them to remind them of their first colposcopy appointment. If patients consent, the investigators also will assess their basic needs during the call. Those who screen positive for at least one unmet basic need, will be referred to the 2-1-1 helpline at their clinic visit (or this information will be sent to them if they miss their clinic visit).
* All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
* For patients in phase 1, the follow-up survey will only assess acceptability of the basic needs survey (five questions)

Group Type ACTIVE_COMPARATOR

Basic needs survey

Intervention Type OTHER

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

Follow-up survey

Intervention Type OTHER

-5 questions about the acceptability of the basic needs survey

Phase 2:

-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey.

The life navigator will connect patients with community resources in each area to help with their unmet basic needs.

* All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
* Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator

Group Type EXPERIMENTAL

Basic needs survey

Intervention Type OTHER

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

Life Navigator

Intervention Type 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

Intervention Type OTHER

-5 questions about the acceptability of the basic needs survey

Follow-up survey (phase II participants only)

Intervention Type OTHER

-7 questions about the effectiveness of the life navigator

Interventions

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Basic needs survey

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

Intervention Type OTHER

Life 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.

Intervention Type BEHAVIORAL

Follow-up survey

-5 questions about the acceptability of the basic needs survey

Intervention Type OTHER

Follow-up survey (phase II participants only)

-7 questions about the effectiveness of the life navigator

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes