Social Needs Support for Cervical Cancer Screening Follow-Up
(BASICS Trial)

Recruiting in Palo Alto (17 mi)

Lindsay M Kuroki, MD, MSCI - Obstetrics ...

Overseen byLindsay M Kuroki, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).

Research Team

Lindsay M Kuroki, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for individuals aged 21 or older who have had an abnormal cervical cancer screening and need a follow-up colposcopy. It's specifically for low-income patients, uninsured, or those on Medicaid who speak English and missed their initial appointment at Washington University School of Medicine.

Inclusion Criteria

Missed appointment at WUSM colposcopy clinic and need to reschedule

Abnormal cervical cancer screen

My cervical screening test showed abnormal results.

See 3 more

Exclusion Criteria

I do not have a cervix.

I am unable to give consent by myself.

I have been diagnosed with or have a history of cancer.

Treatment Details

Interventions

Enhanced usual care (Behavioral Intervention)
Social needs navigator program (Behavioral Intervention)

Trial OverviewThe study compares two approaches: one group will receive support from a social needs navigator program to address unmet social needs and distress, while the other group gets enhanced usual care. Participants are randomly assigned to either group in equal numbers.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: Social needs navigator programExperimental Treatment1 Intervention

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.

Group II: Arm 3: Clinic providerActive Control1 Intervention

4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.

Group III: Arm 2: Enhanced usual careActive Control1 Intervention

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.