Papillomavirus InfectionsDRYNCT01101828
Self-collected Swabs for HPV Testing in 18-24 Year Old Women
An observational study of Papillomavirus Infections, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to compare methods for transporting self-collected swabs for HPV testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year old women. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jan 2011
- Phase
- Observational
- 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 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 18 to 24 year old women who date online
Who may be able to join
- Have had sex with men
- Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)
Who cannot join
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare methods for transporting self-collected swabs for HPV testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year old women.
Read the detailed description
We propose a cross-sectional study among 150 women in the United States who have used Internet dating sites in the past year in order to examine risk factors for high-risk HPV infections in 18-24 year old online daters, and evaluate strategies for transporting and storing self-collected samples for HPV testing. We will ask participants to complete a written questionnaire on their health, sexual behavior, and attitudes toward self-collecting vaginal swabs, HPV vaccination, and cervical cancer screening. Also, we will ask the women to self-collect two sequential vaginal swab samples that will be transported and stored according to the two strategies described above. Each sample will be tested for type-specific HPV DNA using a PCR-based assay.
- Conditions
- Papillomavirus Infections
- Medical subject headings
- Papillomavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of type-specific HPV DNA in self-collected vaginal swab samples
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Rachel L Winer, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101828
- Sponsor's protocol ID
- 37822-A
- Acronym
- DRY
- Status last verified
- Feb 2011
- First submitted
- 7 Apr 2010
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-collected Swabs for HPV Testing in 18-24 Year Old Women
- ClinicalTrials.gov ID
- NCT01101828
- Acronym / sponsor ID
- DRY / 37822-A
- Conditions
- Papillomavirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Apr 2010 (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 purpose of this study is to compare methods for transporting self-collected swabs for HPV testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year old women.
Detailed description
We propose a cross-sectional study among 150 women in the United States who have used Internet dating sites in the past year in order to examine risk factors for high-risk HPV infections in 18-24 year old online daters, and evaluate strategies for transporting and storing self-collected samples for HPV testing. We will ask participants to complete a written questionnaire on their health, sexual behavior, and attitudes toward self-collecting vaginal swabs, HPV vaccination, and cervical cancer screening. Also, we will ask the women to self-collect two sequential vaginal swab samples that will be transported and stored according to the two strategies described above. Each sample will be tested for type-specific HPV DNA using a PCR-based assay.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18 to 24 year old women who date online
Key inclusion criteria (2 listed)
- Have had sex with men
- Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of type-specific HPV DNA in self-collected vaginal swab samples
Time frame: Baseline
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 14 Feb 2011.
- (HPV study website)Link provided by the sponsor.
Related trials for Papillomavirus Infections
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CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
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A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
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Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
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Active, not recruiting
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)
Cervical Carcinoma, Human Papillomavirus Infection
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.
Rachel L Winer, PhD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillomavirus Infections, run by University of Washington 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 2 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 14 Feb 2011. 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?
Presence of type-specific HPV DNA in self-collected vaginal swab samples (time frame: Baseline). 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 14 Feb 2011.