Back to resultsHPV Self-test to Increase Cervical Cancer Screening in Asian Women
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education on cervical cancer prevetnion
Dynamic group interaction
Physician engagement
Patient Navigation
General Health Education
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- gender: female
- age: 30-55
- no current diagnosis of cervical cancer, and
- have not participated in cervical cancer screening within the past 3 years.
Exclusion Criteria:
-
Sites / Locations
- Center for Asian Health, Lewis Katz School of Medicine, Temple University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Specific Education and Dynamic Group
General Health Education
Arm Description
Motivational group education specifically focused on cervical cancer prevention; Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures; Engaging community bilingual physicians in cervical cancer screening and referral; Patient navigation assistance.
Comparison group participants received general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.
Outcomes
Primary Outcome Measures
the change in the rate of cervical cancer screening
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04612660
Brief Title
HPV Self-test to Increase Cervical Cancer Screening in Asian Women
Official Title
Human Papillomavirus (HPV) and Cervical Cancer Intervention to Increase Cervical Cancer Screening for Underserved Asian Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study was to pilot test the feability of using HPV self-sampling testing to increase cervical cancer screening among under-served Asian women through engaging community-based organizations in the greater Philadelphia and New York City area, addressing a significant global cancer burden, the preventable infection-related cervical cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Specific Education and Dynamic Group
Arm Type
Experimental
Arm Description
Motivational group education specifically focused on cervical cancer prevention;
Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures;
Engaging community bilingual physicians in cervical cancer screening and referral;
Patient navigation assistance.
Arm Title
General Health Education
Arm Type
Active Comparator
Arm Description
Comparison group participants received general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.
Intervention Type
Behavioral
Intervention Name(s)
Education on cervical cancer prevetnion
Intervention Description
Motivational group education by trained bilingual community health educators (CHEs) on cervical cancer prevention
Intervention Type
Behavioral
Intervention Name(s)
Dynamic group interaction
Intervention Description
Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures;
Intervention Type
Behavioral
Intervention Name(s)
Physician engagement
Intervention Description
Engaging community bilingual physicians in cervical cancer screening and referral;
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Intervention Description
Patient navigation assistance will be provided to participants who tested HPV positive for further diagnostic testing and treatment.
Intervention Type
Behavioral
Intervention Name(s)
General Health Education
Intervention Description
general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.
Primary Outcome Measure Information:
Title
the change in the rate of cervical cancer screening
Time Frame
baseline, and 6-month follow up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gender: female
age: 30-55
no current diagnosis of cervical cancer, and
have not participated in cervical cancer screening within the past 3 years.
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Ma, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Asian Health, Lewis Katz School of Medicine, Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35193408
Citation
Ma GX, Zhu L, Zhai S, Lin TR, Tan Y, Johnson C, Fang CY, Belinson JL, Wang MQ. Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention. Cancer Control. 2022 Jan-Dec;29:10732748221076813. doi: 10.1177/10732748221076813.
Results Reference
result
Learn more about this trial
HPV Self-test to Increase Cervical Cancer Screening in Asian Women
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