Human Papilloma Virus InfectionNCT06123533
Understanding Women's Values in Managing Human Papillomavirus (HPV)
An observational study of Human Papilloma Virus Infection, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Almost all cervical cancers are caused by infection with a high-risk (hr) HPV. In March 2020, the Scottish Cervical Screening programme changed from a test to look for abnormal cervical cells caused by hr-HPV to a test that looks for infection with hr-HPV itself. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus Infection
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2023to 1 May 2024
- 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 25 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants will be identified through their cervical screening record on Scottish Cervical Call Recall System (SCCRS) records at the Women's Day Clinic (colposcopy clinic) in NHS Grampian.
Who may be able to join
- Non-pregnant, English speaking, female patients aged 25-64 years
- Women with cervical high risk HPV infection
- Normal colposcopy, or, if cytological or histological changes present at colposcopy, a diagnosis of borderline nuclear abnormalities, low grade dyskaryosis or CIN1 only
Who cannot join
- Cytological or histological diagnosis of CIN2+, high grade dyskaryosis, or cervical cancer at colposcopy
- Planned treatments that involve surgical excision e.g. LEEP, LLETZ, conisation or ablation of cervix
- Chronic immunosuppression
- Limited English language proficiency
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aberdeen Centre for Women's Health Research
Aberdeen
About this study
Official title: An Exploratory Study to Understand Women's Values of Management of a Positive Human Papillomavirus (HPV) Test From the Cervical Screening Programme
Almost all cervical cancers are caused by infection with a high-risk (hr) HPV. In March 2020, the Scottish Cervical Screening programme changed from a test to look for abnormal cervical cells caused by hr-HPV to a test that looks for infection with hr-HPV itself. If an HPV infection persists, there is an increased risk of a pre-cancer or cancer of the cervix developing in the future. The cervical screening programme aims to detect and treat pre-cancers, so they don't progress to cancer of the cervix.
Most HPV infections do not cause symptoms and will clear on their own. There are no active treatments available currently. Following a positive hr-HPV result, by waiting and repeating the HPV test after 12 months, it is known that 60% of infections clear in that year and more will clear each year after. Some women are anxious when they find out that they have an HPV infection, and some will look to see if there are any treatments available.
Read more
Several private organisations are offering HPV treatments which are not approved for clinical use yet. These may, or may not, help clear up HPV more quickly or more often.
This study is designed to help us to know and understand whether women have considered treatments, which benefits or risks of such treatments they value, and which factors influence these decisions. The study will also seek to determine participants' willingness to pay for such treatments and will also help to facilitate discussions between clinicians and patients.
Read the detailed description
A scoping review was conducted to determine the background information and evidence available with regards to treatment of persistent human papillomavirus (HPV) in women. This scoping review, which will become a systematic review, evidenced that there was a knowledge gap on how to manage persistent HPV. Several different treatment options were identified, with some studies being conducted as randomised controlled trials and some being conducted as cohort studies.
In March 2020, the Scottish Cervical Screening programme changed from cervical cytology test (test of disease; testing of cells taken by a brush from the cervix and analysed under a microscope) to testing for high-risk HPV (a test of risk). If an HPV infection persists, there is an increased risk of having precancer or cancer of the cervix in the future.
Informing women that they have a viral infection which can result in cancer has in effect created a 'new disease' as women would not have been aware of this infection. Most HPV infections do not cause symptoms and there are no active treatments available in the NHS. This has created concerns for some women who may want to find a treatment and feel that surveillance, where 60% of infections should regress is 'doing nothing.'
Several private organisations are offering HPV treatments which are not available in the NHS, and which may help clear up HPV including HPV vaccination, and probiotics and vaginal gels. This proposal will take steps towards understanding an unmet need among women who have high-risk HPV and who are on early repeat HPV testing. It will seek to understand whether women have considered treatments, which benefits, or risks of such treatments are valued, and which factors influence these decisions as a health economics study.
Although these treatments require further evidence and development prior to being adopted as options for patient care, conducting this research will provide valuable insights into what women value. The profiles of the different treatments vary significantly and understanding patient preferences will help guide prioritisation. Understanding initially how women feel about their HPV diagnosis and the available treatments will be important to design a pilot discrete choice experiment (DCE) and usable DCE to understand, in quantitative terms, what women seek, prioritise and are willing to pay for in their care for HPV.
This study is being performed to provide valuable insights to conduct a DCE. The results of the participant interviews and the DCE will be highly useful to help inform policy, guidelines and clinical recommendations for the management of women with persistent HPV.
- Conditions
- Human Papilloma Virus Infection
- Being tested
- No intervention
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
% of participants who feel certain key factors of care are important to them in making choices about how to manage their HPV diagnosis.
Participants will be asked about a number of factors and their opinions on how they influence their treatment decisions, including price, mode of treatment, frequency of treatment and duration of treatment. Interview transcripts will be analysed to determine themes through thematic analysis. This will allow the investigators to understand what is important to participants. This information is required to create a pilot DCE, to further understand the wants and needs of those with persistent HPV.
Measured: March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start6 Nov 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus InfectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123533
- Sponsor's protocol ID
- 2-039-23
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2023
- Last updated
- 31 Aug 2026
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Understand Women's Values of Management of a Positive Human Papillomavirus (HPV) Test From the Cervical Screening Programme
- ClinicalTrials.gov ID
- NCT06123533
- Acronym / sponsor ID
- 2-039-23
- Conditions
- Human Papilloma Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 8 Nov 2023 (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.
Almost all cervical cancers are caused by infection with a high-risk (hr) HPV. In March 2020, the Scottish Cervical Screening programme changed from a test to look for abnormal cervical cells caused by hr-HPV to a test that looks for infection with hr-HPV itself. If an HPV infection persists, there is an increased risk of a pre-cancer or cancer of the cervix developing in the future. The cervical screening programme aims to detect and treat pre-cancers, so they don't progress to cancer of the cervix.
Most HPV infections do not cause symptoms and will clear on their own. There are no active treatments available currently. Following a positive hr-HPV result, by waiting and repeating the HPV test after 12 months, it is known that 60% of infections clear in that year and more will clear each year after. Some women are anxious when they find out that they have an HPV infection, and some will look to see if there are any treatments available.
Several private organisations are offering HPV treatments which are not approved for clinical use yet. These may, or may not, help clear up HPV more quickly or more often.
This study is designed to help us to know and understand whether women have considered treatments, which benefits or risks of such treatments they value, and which factors influence these decisions. The study will also seek to determine participants' willingness to pay for such treatments and will also help to facilitate discussions between clinicians and patients.
Detailed description
A scoping review was conducted to determine the background information and evidence available with regards to treatment of persistent human papillomavirus (HPV) in women. This scoping review, which will become a systematic review, evidenced that there was a knowledge gap on how to manage persistent HPV. Several different treatment options were identified, with some studies being conducted as randomised controlled trials and some being conducted as cohort studies.
In March 2020, the Scottish Cervical Screening programme changed from cervical cytology test (test of disease; testing of cells taken by a brush from the cervix and analysed under a microscope) to testing for high-risk HPV (a test of risk). If an HPV infection persists, there is an increased risk of having precancer or cancer of the cervix in the future.
Informing women that they have a viral infection which can result in cancer has in effect created a 'new disease' as women would not have been aware of this infection. Most HPV infections do not cause symptoms and there are no active treatments available in the NHS. This has created concerns for some women who may want to find a treatment and feel that surveillance, where 60% of infections should regress is 'doing nothing.'
Several private organisations are offering HPV treatments which are not available in the NHS, and which may help clear up HPV including HPV vaccination, and probiotics and vaginal gels. This proposal will take steps towards understanding an unmet need among women who have high-risk HPV and who are on early repeat HPV testing. It will seek to understand whether women have considered treatments, which benefits, or risks of such treatments are valued, and which factors influence these decisions as a health economics study.
Although these treatments require further evidence and development prior to being adopted as options for patient care, conducting this research will provide valuable insights into what women value. The profiles of the different treatments vary significantly and understanding patient preferences will help guide prioritisation. Understanding initially how women feel about their HPV diagnosis and the available treatments will be important to design a pilot discrete choice experiment (DCE) and usable DCE to understand, in quantitative terms, what women seek, prioritise and are willing to pay for in their care for HPV.
This study is being performed to provide valuable insights to conduct a DCE. The results of the participant interviews and the DCE will be highly useful to help inform policy, guidelines and clinical recommendations for the management of women with persistent HPV.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be identified through their cervical screening record on Scottish Cervical Call Recall System (SCCRS) records at the Women's Day Clinic (colposcopy clinic) in NHS Grampian.
Key inclusion criteria (3 listed)
- Non-pregnant, English speaking, female patients aged 25-64 years
- Women with cervical high risk HPV infection
- Normal colposcopy, or, if cytological or histological changes present at colposcopy, a diagnosis of borderline nuclear abnormalities, low grade dyskaryosis or CIN1 only
Key exclusion criteria (4 listed)
- Cytological or histological diagnosis of CIN2+, high grade dyskaryosis, or cervical cancer at colposcopy
- Planned treatments that involve surgical excision e.g. LEEP, LLETZ, conisation or ablation of cervix
- Chronic immunosuppression
- Limited English language proficiency
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 |
|---|---|---|
| No interventionThere is no intervention. | Other | – |
Primary outcome
% of participants who feel certain key factors of care are important to them in making choices about how to manage their HPV diagnosis.
Time frame: March 2024
Participants will be asked about a number of factors and their opinions on how they influence their treatment decisions, including price, mode of treatment, frequency of treatment and duration of treatment. Interview transcripts will be analysed to determine themes through thematic analysis. This will allow the investigators to understand what is important to participants. This information is required to create a pilot DCE, to further understand the wants and needs of those with persistent HPV.
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 31 Aug 2026.
- 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?
An observational study of Human Papilloma Virus Infection, run by University of Aberdeen at 1 site in United Kingdom.
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 3 inclusion and 4 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 31 Aug 2026. 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 Kingdom. 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?
% of participants who feel certain key factors of care are important to them in making choices about how to manage their HPV diagnosis. (time frame: March 2024). 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 31 Aug 2026.