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

Temple University Health System (TUHS)

Status: Active, not recruiting

Conditions: Uterine Cervical Neoplasms

Treatments: Behavioral: HPV Self-Sampling; Behavioral: Community-Based Education; Behavioral: Navigation to Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT04557423

19-1058

Details and patient eligibility

About

This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Asian American (Korean, Vietnamese, and Chinese) 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.

Full description

Aim 1: Compare rates of providing a self-collected sample vs. obtaining clinic-based screening among 1100 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.

Enrollment: 797 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women who are of Asian race and self-identify as Korean, Vietnamese, or Chinese
• 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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797 participants in 2 patient groups

Evidence-Based Intervention

Active Comparator group

Description:

Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided.

Treatment:

Behavioral: Navigation to Screening

Behavioral: Community-Based Education

HPV Self-Sampling

Experimental group

Description:

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.

Treatment:

Behavioral: Navigation to Screening

Behavioral: HPV Self-Sampling

Behavioral: Community-Based Education