Evidence-Based Approach to Empower Asian American Women in Cervical Cancer Screening

Study Overview
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Brief Summary
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This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Korean and Vietnamese American women. All women will receive an educational program and navigation assistance. Women in the intervention condition will also receive a self-sampling kit for self-collection of a cervical sample for HPV testing. The investigators will evaluate whether the inclusion of a self-sampling kit increases the proportion of Asian American women who participate in cervical cancer screening.

Detailed Description
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Aim 1: Compare rates of providing a self-collected sample vs. obtaining clinic-based screening among 800 Asian American women. It is hypothesized that the proportion of women in the HPV self-sampling program who provide a self-collected sample will be higher than the proportion of women in the clinic-based program who obtain clinic-based screening. Aim 2: Examine mediators of participation. The investigators will examine both individual- and social/environmental-level factors associated with participation across both programs. It is hypothesized that higher levels of perceived self-efficacy, lower levels of embarrassment, and fewer barriers will be associated with higher rates of participation in both conditions. Further, it is hypothesized that women in the HPV self-sampling program will report greater self-efficacy, less embarrassment, and fewer barriers compared to women in the clinic-based program. Aim 3: Assess the relative cost-effectiveness of HPV self-sampling vs. clinic-based screening. The investigators will conduct an incremental cost-effectiveness analysis from a societal perspective incorporating trial-based direct medical and participant-borne costs associated with HPV self-sampling vs. clinic-based screening. It is hypothesized that the self-sampling program will be less costly to implement and achieve a higher participation rate.

Official Title
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Evidence-Based Approach to Empower Asian American Women in Cervical Cancer Screening

Conditions
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Uterine Cervical Neoplasms

Intervention / Treatment
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* Behavioral: Community-Based Education
* Behavioral: Navigation to Screening
* Behavioral: HPV Self-Sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are of Asian race and self-identify as Korean or Vietnamese are 30-65 years of age are overdue for cervical cancer screening (e.g., no cytology-based screening within the past 3 years; no hrHPV testing either alone or in combination with cytology in the past 5 years) Exclusion Criteria: have a prior diagnosis of cervical cancer or cervical abnormality (e.g., dysplasia) had a hysterectomy with removal of the cervix have a compromised immune system (e.g., known HIV) unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Evidence-Based Intervention<br>Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided. | Behavioral: Community-Based Education<br>* A previously evaluated educational intervention delivered in community settings. Includes culturally- and linguistically-appropriate materials.<br>Behavioral: Navigation to Screening<br>* Community health educators provide navigation assistance to access clinic-based cervical cancer screening.<br>|
| Experimental: HPV Self-Sampling<br>Previously tested evidence-based intervention (i.e. culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided). Participants will also receive a self-sampling kit. | Behavioral: Community-Based Education<br>* A previously evaluated educational intervention delivered in community settings. Includes culturally- and linguistically-appropriate materials.<br>Behavioral: Navigation to Screening<br>* Community health educators provide navigation assistance to access clinic-based cervical cancer screening.<br>Behavioral: HPV Self-Sampling<br>* An HPV self-sampling kit will be provided for home-based collection of cervical samples. Samples will be sent for analysis of HPV subtypes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation in screening | The number of women who obtain clinic-based screening or return a self-collected sample | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program delivery cost | The costs associated with delivering each program. This will include: (1) Participant costs (time spent participating in educational sessions and time required to complete screening; transportation costs, if incurred); (2) Screening costs (cost of clinic-based screening, or cost of the HPV self-sampling kit); (3) Program delivery costs (community health educator time for conducting the educational programs, time will be valued at wage rates including benefits; costs of educational materials [flyers, booklets] and reminder letters); (4) Navigation costs (time and labor involved in navigating women to the clinic for screening will be documented using a log of CHE time and expenses incurred). | 6 months |