Understanding Women's Values in Managing Human Papillomavirus (HPV)

NCT06123533 | Unknown

• 1 other identifier: 2-039-23
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Human Papilloma Virus Infection

Outcome Measures

Primary Outcomes (1)

• % 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.

  March 2024

Interventions

No intervention OTHER

There is no intervention.

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 8, 2023
• Study Start: November 6, 2023
• Primary Completion: February 1, 2024
• Study Completion: December 31, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share