Cervical Cancer ScreeningNCT03222817
HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals
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 Papillomavirus (HPV) self-sampling intervention for unscreened and under-screened transgender men and transmasculine individuals living in South Florida. 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
- 12 May 2018to 17 Oct 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 transgender male or as transmasculine
- Assigned female sex at birth
- English speaking
- ages 25-65 years
- report not having had a pap smear in the last three years
- if age 30 and over, report not having a Pap smear/HPV co-test in the past 5 years
Who cannot join
- • Those who report having had a hysterectomy
- Those who report having history of cervical cancer
- Adults unable to consent
- Those who are pregnant
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study will examine the implementation of a Human Papillomavirus (HPV) self-sampling intervention for unscreened and under-screened transgender men and transmasculine individuals living in South Florida. The study will enroll participants to receive this cervical cancer screening 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
Participants will be provided with education regarding cervical cancer screening, as well as instructions regarding how to use the HPV self-sampler. Participants will also receive referrals to trans-competent healthcare providers for follow-up screening and care.
| Study group | Role | What they receive |
|---|---|---|
| HPV Self-sampling | Experimental | All participants will receive HPV self-sampling. HPV self-sampling allows an individual to screen themselves for cervical cancer in private, using a device that is similar to a tampon. Receives: Behavioral: HPV self-sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of HPV self-sampling Questionnaire
This questionnaire, designed with substantial input from community partners, will gauge how acceptable the participants find HPV self-sampling through both closed and open-ended questions regarding ease of use, preference of self-sampler vs. physician-collected Pap smear, as well as open-ended inquiries regarding the self-sampling process.
Measured: This questionnaire will be administered immediately after participants self-sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start12 May 2018
- Primary completion17 Oct 2018
- Study completion17 Oct 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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222817
- Sponsor's protocol ID
- 20170329
- Status last verified
- May 2019
- First submitted
- 17 Jul 2017
- Last updated
- 3 May 2019
- 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 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals
- ClinicalTrials.gov ID
- NCT03222817
- Acronym / sponsor ID
- 20170329
- Conditions
- Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 May 2018 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 19 Jul 2017 (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 proposed study will examine the implementation of a Human Papillomavirus (HPV) self-sampling intervention for unscreened and under-screened transgender men and transmasculine individuals living in South Florida. The study will enroll participants to receive this cervical cancer screening 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 | Experimental | Behavioral: HPV self-samplingAll participants will receive HPV self-sampling. HPV self-sampling allows an individual to screen themselves for cervical cancer in private, using a device that is similar to a tampon. |
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 transgender male or as transmasculine
Key exclusion criteria (5 listed)
- • Those who report having had a hysterectomy
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-samplingParticipants will be provided with education regarding cervical cancer screening, as well as instructions regarding how to use the HPV self-sampler. Participants will also receive referrals to trans-competent healthcare providers for follow-up screening and care. | Behavioural | HPV Self-sampling |
Primary outcome
Acceptability of HPV self-sampling Questionnaire
Time frame: This questionnaire will be administered immediately after participants self-sample
This questionnaire, designed with substantial input from community partners, will gauge how acceptable the participants find HPV self-sampling through both closed and open-ended questions regarding ease of use, preference of self-sampler vs. physician-collected Pap smear, as well as open-ended inquiries regarding the self-sampling process.
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 3 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 May 2019. 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?
Acceptability of HPV self-sampling Questionnaire (time frame: This questionnaire will be administered immediately after participants self-sample). 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 3 May 2019.