Cervical CancerNCT04612660
HPV Self-test to Increase Cervical Cancer Screening in Asian Women
A study testing Education on cervical cancer prevetnion, Dynamic group interaction and Physician engagement in people with Cervical Cancer, run by Temple University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Education on cervical cancer prevetnion, Dynamic group interaction and Physician engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- gender: female
- age: 30-55
- no current diagnosis of cervical cancer, and
- have not participated in cervical cancer screening within the past 3 years.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Asian Health, Lewis Katz School of Medicine, Temple University
Philadelphia, Pennsylvania, 19140
About this study
Official title: 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.
- Conditions
- Cervical Cancer
- Being tested
- Education on cervical cancer prevetnion, Dynamic group interaction, Physician engagement, Patient Navigation, General Health Education
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on cervical cancer prevetnionBehavioural
Motivational group education by trained bilingual community health educators (CHEs) on cervical cancer prevention
Dynamic group interactionBehavioural
Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures;
Physician engagementBehavioural
Engaging community bilingual physicians in cervical cancer screening and referral;
Patient NavigationBehavioural
Patient navigation assistance will be provided to participants who tested HPV positive for further diagnostic testing and treatment.
General Health EducationBehavioural
general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education on cervical cancer prevetnion; Behavioral: Dynamic group interaction; Behavioral: Physician engagement; Behavioral: 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. Receives: Behavioral: General Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in the rate of cervical cancer screening
Measured: baseline, and 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Ma, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612660
- Sponsor's protocol ID
- HPV Self-sampling
- Status last verified
- Sep 2022
- First submitted
- 28 Oct 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35193408
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus (HPV) and Cervical Cancer Intervention to Increase Cervical Cancer Screening for Underserved Asian Women
- ClinicalTrials.gov ID
- NCT04612660
- Acronym / sponsor ID
- HPV Self-sampling
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific Education and Dynamic Group | Experimental | Behavioral: Education on cervical cancer prevetnion, Behavioral: Dynamic group interaction, Behavioral: Physician engagement, Behavioral: Patient Navigation1. 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. |
| General Health Education | Active comparator | Behavioral: General Health EducationComparison group participants received general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- gender: female
- age: 30-55
- no current diagnosis of cervical cancer, and
- have not participated in cervical cancer screening within the past 3 years.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on cervical cancer prevetnionMotivational group education by trained bilingual community health educators (CHEs) on cervical cancer prevention | Behavioural | Specific Education and Dynamic Group |
| Dynamic group interactionDynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures; | Behavioural | Specific Education and Dynamic Group |
| Physician engagementEngaging community bilingual physicians in cervical cancer screening and referral; | Behavioural | Specific Education and Dynamic Group |
| Patient NavigationPatient navigation assistance will be provided to participants who tested HPV positive for further diagnostic testing and treatment. | Behavioural | Specific Education and Dynamic Group |
| General Health Educationgeneral health education focusing on healthy lifestyle, and prevention of disease through routine health examinations. | Behavioural | General Health Education |
Primary outcome
the change in the rate of cervical cancer screening
Time frame: baseline, and 6-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Results publication: PubMed 35193408Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Ma, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on cervical cancer prevetnion, Dynamic group interaction and Physician engagement in people with Cervical Cancer, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in the rate of cervical cancer screening (time frame: baseline, and 6-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04612660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.