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HPV vaccine and screening brought to women who need it most

NCT ID NCT06414057

Prevention Sponsor: University of Edinburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to make cervical cancer prevention easier for women who often miss out on routine care, such as those experiencing homelessness, substance use, or incarceration. Researchers will offer the HPV vaccine (Gardasil-9) and a self-swab test during regular sexual health clinic visits. They will track how many women accept the offer and complete the vaccine series, and gather feedback to design better services.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gardasil-9 (HPV vaccine)
What this could lead to
If successful, this could show that offering HPV vaccines during routine sexual health visits is a practical way to reach and protect women who often miss standard screening and vaccination.
What could go wrong
This is a small, early feasibility study (500 participants) focused on uptake and attitudes, not on directly preventing cancer. Results may not apply to other regions or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult women, trans men, or non-binery individuals with a cervix attending routine sexual health services who aslo have experience of substance use/addiction, living in custodial settings, homelessness, or involvement in transactional sex.

Ages

25 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Individuals will be eligible for participation in components 1 and/or 2 if they: * have a cervix * are aged 25-45 years (inclusive) * are able to provide informed consent for themself And have experience of either: * substance use/addiction * living in custodial settings * homelessness * involvement in transactional sex Exclusion Criteria: Individuals will be excluded from participation if they: * Do not have a cervix due to surgery or other reasons * Are known to have completed the full vaccination schedule (as per JCVI criteria for their age and immunocompetency) (Excluded from component 1 (vaccination and HPV screening) only - still able to participate in component 2 (individual interview)) * Meet any of the vaccine exclusion criteria as set out in the local HPV PGD * Have had a confirmed anaphylactic reaction to a previous dose of HPV vaccine. * Have had a confirmed anaphylactic reaction to any component of the vaccine. Practitioners must check the marketing authorisation holder's SmPC for details of vaccine components. * Have a history of severe (i.e. anaphylactic reaction) to latex where the vaccine is not latex free. * Are known to be pregnant. * Are suffering from an acute severe febrile illness (the presence of a minor infection is not a contraindication for immunisation). Additionally, PGDs advise caution where a neurological condition is believed to be progressing or there is neurological deterioration and therefore, individuals meeting this criteria will be excluded (from component 1 only).

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Conditions

The condition(s) this trial relates to.

human papilloma virus infection cervical cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human papilloma virus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NHS Lothian

    RECRUITING

    Edinburgh, United Kingdom

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