NCT04612660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

October 28, 2020

Last Update Submit

September 27, 2022

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • the change in the rate of cervical cancer screening

    baseline, and 6-month follow up

Study Arms (2)

Specific Education and Dynamic Group

EXPERIMENTAL

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 prevetnionBehavioral: Dynamic group interactionBehavioral: Physician engagementBehavioral: Patient Navigation

General Health Education

ACTIVE COMPARATOR

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

Behavioral: General Health Education

Interventions

Education on cervical cancer prevetnionBEHAVIORAL

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

Specific Education and Dynamic Group
Dynamic group interactionBEHAVIORAL

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

Specific Education and Dynamic Group
Physician engagementBEHAVIORAL

Engaging community bilingual physicians in cervical cancer screening and referral;

Specific Education and Dynamic Group
Patient NavigationBEHAVIORAL

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

Specific Education and Dynamic Group
General Health EducationBEHAVIORAL

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

General Health Education

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • 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.

    PMID: 35193408RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Physician EngagementPatient Navigation

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Work EngagementPersonnel ManagementOrganization and AdministrationHealth Services AdministrationDelivery of Health CarePatient Care ManagementHealth Care Quality, Access, and EvaluationPatient-Centered CarePrimary Health CareComprehensive Health Care

Study Officials

  • Grace Ma, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 3, 2020

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 30, 2022

Record last verified: 2022-09

Locations

US(1)