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

NCT ID: NCT04612660

Last Updated: 2022-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Education on cervical cancer prevetnion

Intervention Type BEHAVIORAL

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

Dynamic group interaction

Intervention Type BEHAVIORAL

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

Physician engagement

Intervention Type BEHAVIORAL

Engaging community bilingual physicians in cervical cancer screening and referral;

Patient Navigation

Intervention Type BEHAVIORAL

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

General Health Education

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

Group Type ACTIVE_COMPARATOR

General Health Education

Intervention Type BEHAVIORAL

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

Interventions

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Education on cervical cancer prevetnion

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

Intervention Type BEHAVIORAL

Dynamic group interaction

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

Intervention Type BEHAVIORAL

Physician engagement

Engaging community bilingual physicians in cervical cancer screening and referral;

Intervention Type BEHAVIORAL

Patient Navigation

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

Intervention Type BEHAVIORAL

General Health Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grace Ma, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Center for Asian Health, Lewis Katz School of Medicine, Temple University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 35193408 (View on PubMed)

Other Identifiers

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HPV Self-sampling

Identifier Type: -

Identifier Source: org_study_id

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