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

September 27, 2022 updated by: Temple University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Center for Asian Health, Lewis Katz School of Medicine, Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. gender: female
  2. age: 30-55
  3. no current diagnosis of cervical cancer, and
  4. have not participated in cervical cancer screening within the past 3 years.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Specific Education and Dynamic Group
  1. Motivational group education specifically focused on cervical cancer prevention;
  2. Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures;
  3. Engaging community bilingual physicians in cervical cancer screening and referral;
  4. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the change in the rate of cervical cancer screening
Time Frame: baseline, and 6-month follow up
baseline, and 6-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Investigators

  • Principal Investigator: Grace Ma, PhD, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV Self-sampling

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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