Addressing Unmet Basic Needs to Improve Adherence Among W... | NCT03317470

NCT03317470

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase I:	Active Comparator	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)	Other: Basic needs survey Other: Follow-up survey
Phase 2:	Experimental	-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	Other: Basic needs survey Behavioral: Life Navigator Other: Follow-up survey Other: Follow-up survey (phase II participants only)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Basic needs survey	Other	-11 questions about food security, housing personal safety, neighborhood safety, childcare, and transportation	Phase 2: Phase I:

Outcomes Module

Measure	Description	Time Frame
Participant adherence to initial colposcopy visit	-Will use weekly clinic schedules to track adherence rates	At the time of initial colposcopy visit

Secondary Outcomes

Measure	Description	Time Frame
Number of unmet basic needs	-Data obtained from Basic Needs Survey	-2 weeks prior to initial colposcopy visits
Type of unmet basic needs	-Data obtained from Basic Needs Survey

Eligibility Module

Name	Affiliation	Role
Lindsay M Kuroki, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Southern Illinois University School of Medicine		Springfield	Illinois	62794	United States
Washington University School of Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33631781	Derived	Kuroki L, Massad LS, Martin A, Liu J, Brown D, Leon A, Groesch K, Wilson T, Zeino Y, Diaz-Sylvester P, Delfino K, Hyon K, Kreuter M. Addressing Unmet Basic Needs to Improve Colposcopy Adherence Among Women With Abnormal Cervical Cancer Screening. J Low Genit Tract Dis. 2021 Apr 1;25(2):106-112. doi: 10.1097/LGT.0000000000000593.