Clinical trial NCT04557423: Evidence-Based Approach to Empower Asian American Women in Cervical Cancer Screening
Official title: Evidence-Based Approach to Empower Asian American Women in Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: Temple University
First posted: 2020-09-21
Enrollment: 797
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participation in screening
timeFrame: 6 months
Secondary outcomes:
measure: Program delivery cost
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Lewis Katz School of Medicine
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Carolyn Y Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References: