Cervical CancerNCT03551028
HPV DNA Testing Through Mobile Mammography Unit
A study testing HPV self collection in people with Cervical Cancer, run by University of Virginia at 1 site in United States.
Trial summary
Invasive cervical cancer incidence and mortality can be dramatically reduced through early detection and treatment, but many women do not complete screening at recommended intervals. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV self collection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- not pregnant
Who cannot join
- history of hysterectomy or pelvic RT non English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by the Mobile
Invasive cervical cancer incidence and mortality can be dramatically reduced through early detection and treatment, but many women do not complete screening at recommended intervals. Many low-income women in Virginia remain uninsured and are at significant risk of being medically underserved and failing to complete regular cervical cancer screening. Self-collection of specimens for HPV testing is an innovative approach that may increase access to cervical cancer screening in populations that do not participate in traditional clinic-based screening. Innovative delivery models are needed to reach at-risk populations. This study seeks to explore the acceptability and feasibility of pairing self-collection of HPV samples for DNA testing with mobile mammography in women living in rural Virginia.
Read the detailed description
The proposed study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in rural Virginia. The procedures will be recruitment of under-screened women in rural Virginia to complete HPV testing using self-collection kits distributed through the mobile mammography unit. Regardless of HPV positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.
- Conditions
- Cervical Cancer
- Being tested
- HPV self collection
- 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.
HPV self collectionDevice
The proposed community based participatory study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in Southwest Virginia.
| Study group | Role | What they receive |
|---|---|---|
| HPV self collection | Other | Pairing self-collection of HPV samples for DNA testing with women seeking mobile mammography. Receives: Device: HPV self collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Self-Collection Paired With Mobile Mammography
Assess the cultural acceptability of self-collection for HPV testing among under-screened women in Southwest Virginia specifically who were seeking a mammogram at an episodic clinic. The outcome measure of ACCEPTABILITY was measured through: participants who opted in, or uptake of HPV self collection (yes/no); and intention to follow up upon learning of result.
Measured: 1 month (to allow for time to process samples and communicate results)
Feasibility of Self-Collection for HPV Paired With Mobile Mammography
Assess the feasibility of self-collection for HPV testing among under-screened women in Southwest Virginia who were seeking a mammogram at an episodic clinic. FEASIBILITY was measured through: participant uptake of HPV self collection (yes/no); observations of clinic flow (i.e. how did this additional screening fit in with existing mammography services); and quality of samples collected (were any collected inaccurately or in a way that was impossible to detect).
Measured: 1 month (to allow for time to process samples and communicate results)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study startJul 2016
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma McKim Mitchell, University of Virginia
- Investigators
- Emma M Mitchell, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551028
- Sponsor's protocol ID
- 19110
- Status last verified
- Oct 2024
- First submitted
- 1 May 2017
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gravitt PE, Belinson JL, Salmeron J, Shah KV. Looking ahead: a case for human papillomavirus testing of self-sampled vaginal specimens as a cervical cancer screening strategy. Int J Cancer. 2011 Aug 1;129(3):517-27. doi: 10.1002/ijc.25974.
PubMed 21384341Balasubramanian A, Kulasingam SL, Baer A, Hughes JP, Myers ER, Mao C, Kiviat NB, Koutsky LA. Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples. J Low Genit Tract Dis. 2010 Jul;14(3):185-95. doi: 10.1097/LGT.0b013e3181cd6d36.
PubMed 20592553
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by the Mobile
- ClinicalTrials.gov ID
- NCT03551028
- Acronym / sponsor ID
- 19110
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Posted 4 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Invasive cervical cancer incidence and mortality can be dramatically reduced through early detection and treatment, but many women do not complete screening at recommended intervals. Many low-income women in Virginia remain uninsured and are at significant risk of being medically underserved and failing to complete regular cervical cancer screening. Self-collection of specimens for HPV testing is an innovative approach that may increase access to cervical cancer screening in populations that do not participate in traditional clinic-based screening. Innovative delivery models are needed to reach at-risk populations. This study seeks to explore the acceptability and feasibility of pairing self-collection of HPV samples for DNA testing with mobile mammography in women living in rural Virginia.
Detailed description
The proposed study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in rural Virginia. The procedures will be recruitment of under-screened women in rural Virginia to complete HPV testing using self-collection kits distributed through the mobile mammography unit. Regardless of HPV positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV self collection | Other | Device: HPV self collectionPairing self-collection of HPV samples for DNA testing with women seeking mobile mammography. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- not pregnant
Key exclusion criteria (1 listed)
- history of hysterectomy or pelvic RT non English speaking
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 |
|---|---|---|
| HPV self collectionThe proposed community based participatory study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in Southwest Virginia. | Device | HPV self collection |
Primary outcome
Acceptability of Self-Collection Paired With Mobile Mammography
Time frame: 1 month (to allow for time to process samples and communicate results)
Assess the cultural acceptability of self-collection for HPV testing among under-screened women in Southwest Virginia specifically who were seeking a mammogram at an episodic clinic. The outcome measure of ACCEPTABILITY was measured through: participants who opted in, or uptake of HPV self collection (yes/no); and intention to follow up upon learning of result.
Feasibility of Self-Collection for HPV Paired With Mobile Mammography
Time frame: 1 month (to allow for time to process samples and communicate results)
Assess the feasibility of self-collection for HPV testing among under-screened women in Southwest Virginia who were seeking a mammogram at an episodic clinic. FEASIBILITY was measured through: participant uptake of HPV self collection (yes/no); observations of clinic flow (i.e. how did this additional screening fit in with existing mammography services); and quality of samples collected (were any collected inaccurately or in a way that was impossible to detect).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21384341Gravitt PE, Belinson JL, Salmeron J, Shah KV. Looking ahead: a case for human papillomavirus testing of self-sampled vaginal specimens as a cervical cancer screening strategy. Int J Cancer. 2011 Aug 1;129(3):517-27. doi: 10.1002/ijc.25974.
- Background: PubMed 20592553Balasubramanian A, Kulasingam SL, Baer A, Hughes JP, Myers ER, Mao C, Kiviat NB, Koutsky LA. Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples. J Low Genit Tract Dis. 2010 Jul;14(3):185-95. doi: 10.1097/LGT.0b013e3181cd6d36.
- Individual participant dataSharing planned: No
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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.
Emma M Mitchell, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV self collection in people with Cervical Cancer, run by University of Virginia 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 1 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 4 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptability of Self-Collection Paired With Mobile Mammography (time frame: 1 month (to allow for time to process samples and communicate results)). The study lists 2 primary outcomes in all. 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 NCT03551028, which also lists 2 linked publications.
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 4 Nov 2024.