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

The Washington University

Status and phase: Completed; Phase 1

Conditions: Abnormal Pap Smear; Colposcopy

Treatments: Other: Follow-up survey; Behavioral: Life Navigator; Other: Follow-up survey (phase II participants only); Other: Basic needs survey

Study type: Interventional

Funder types: Other

Identifiers

NCT03317470

201708116

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

96 participants in 2 patient groups

Phase I:

Active Comparator group

Description:

* 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)

Treatment:

Other: Follow-up survey

Other: Basic needs survey

Phase 2:

Experimental group

Description:

-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

Treatment:

Other: Follow-up survey

Behavioral: Life Navigator

Other: Basic needs survey

Other: Follow-up survey (phase II participants only)