Cervical Cancer ScreeningNCT03012932
HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women
A study testing HPV self-sampling in people with Cervical Cancer Screening, run by University of Miami at 1 site in United States.
Trial summary
The proposed study will examine the implementation of a Human Papilloma Virus (HPV) self-sampling intervention for under screened LBQ women living in South Florida. The study will enroll participants to receive the self-sampling intervention in community venues. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- HPV self-sampling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2017to 24 Mar 2018
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as lesbian, bisexual, or queer woman
- Assigned female sex at birth
- English speaking
- ages 25-65 years
- report not having had a pap smear in the last three years (per USPSTF guidelines)
- if age 30 or over, report not having a pap smear/HPV co-test within the past 5 years (per USPSTF guidelines)
Who cannot join
- report having had a hysterectomy
- report having history of cervical cancer
- unable to consent
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women: A Pilot Study
The proposed study will examine the implementation of a Human Papilloma Virus (HPV) self-sampling intervention for under screened LBQ women living in South Florida. The study will enroll participants to receive the self-sampling intervention in community venues. The purpose of this study is to pilot the self-sampler for feasibility and acceptability within this underserved population.
- Conditions
- Cervical Cancer Screening
- Being tested
- HPV self-sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV self-samplingBehavioural
All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.
| Study group | Role | What they receive |
|---|---|---|
| HPV Self-sampling | Other | All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only. Receives: Behavioral: HPV self-sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Self-sampling uptake
Percentage of eligible women who complete HPV self-sampling
Measured: through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start2 Feb 2017
- Primary completion24 Mar 2018
- Study completion24 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Seay, University of Miami
- Investigators
- Julia Seay, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012932
- Sponsor's protocol ID
- 20161052
- Status last verified
- Sep 2018
- First submitted
- 3 Jan 2017
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT03012932
- Acronym / sponsor ID
- 20161052
- Conditions
- Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 24 Mar 2018 (actual)
- Study completion
- 24 Mar 2018 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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 proposed study will examine the implementation of a Human Papilloma Virus (HPV) self-sampling intervention for under screened LBQ women living in South Florida. The study will enroll participants to receive the self-sampling intervention in community venues. The purpose of this study is to pilot the self-sampler for feasibility and acceptability within this underserved population.
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-sampling | Other | Behavioral: HPV self-samplingAll participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identify as lesbian, bisexual, or queer woman
- Assigned female sex at birth
- English speaking
- ages 25-65 years
- report not having had a pap smear in the last three years (per USPSTF guidelines)
Key exclusion criteria (5 listed)
- report having had a hysterectomy
- report having history of cervical cancer
- unable to consent
- Pregnant women
- Prisoners
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-samplingAll participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only. | Behavioural | HPV Self-sampling |
Primary outcome
HPV Self-sampling uptake
Time frame: through study completion, up to 1 year
Percentage of eligible women who complete HPV self-sampling
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 26 Sep 2018.
- 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.
Julia Seay, PhD principal investigator
University of Miami
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-sampling in people with Cervical Cancer Screening, run by University of Miami 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 6 inclusion and 5 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 26 Sep 2018. 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?
HPV Self-sampling uptake (time frame: through study completion, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2018.