HPV Self-test to Increase Cervical Cancer Screening in Asian Women

Sponsor

Temple University (Other)

Overall Status

Completed

CT.gov ID

NCT04612660

Collaborator

(none)

293

Enrollment

Location

Arms

Actual Duration (Months)

29.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Behavioral: Education on cervical cancer prevetnion Behavioral: Dynamic group interaction Behavioral: Physician engagement Behavioral: Patient Navigation Behavioral: General Health Education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

293 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Human Papillomavirus (HPV) and Cervical Cancer Intervention to Increase Cervical Cancer Screening for Underserved Asian Women

Actual Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Specific Education and Dynamic Group 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.	Behavioral: Education on cervical cancer prevetnion Motivational group education by trained bilingual community health educators (CHEs) on cervical cancer prevention Behavioral: Dynamic group interaction Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures; Behavioral: Physician engagement Engaging community bilingual physicians in cervical cancer screening and referral; Behavioral: Patient Navigation Patient navigation assistance will be provided to participants who tested HPV positive for further diagnostic testing and treatment.
Active Comparator: General Health Education Comparison group participants received general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.	Behavioral: General Health Education general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.

Arm

Intervention/Treatment

Experimental: Specific Education and Dynamic Group

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.

Behavioral: Education on cervical cancer prevetnion

Motivational group education by trained bilingual community health educators (CHEs) on cervical cancer prevention

Behavioral: Dynamic group interaction

Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures;

Behavioral: Physician engagement

Engaging community bilingual physicians in cervical cancer screening and referral;

Behavioral: Patient Navigation

Patient navigation assistance will be provided to participants who tested HPV positive for further diagnostic testing and treatment.

Active Comparator: General Health Education

Comparison group participants received general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.

Behavioral: General Health Education

general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.

Outcome Measures

Primary Outcome Measures

the change in the rate of cervical cancer screening [baseline, and 6-month follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Asian Health, Lewis Katz School of Medicine, Temple University	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

Temple University

Investigators

Principal Investigator: Grace Ma, PhD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Temple University

ClinicalTrials.gov Identifier:

NCT04612660

Other Study ID Numbers:

HPV Self-sampling

First Posted:

Nov 3, 2020

Last Update Posted:

Nov 3, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Nov 3, 2020