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At-Home HPV test could revolutionize screening for women with autoimmune conditions

NCT ID NCT06302725

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Updated 3 times

Summary

This study looks at whether women with immune-mediated inflammatory diseases (like lupus or Sjögren's syndrome) can use a vaginal self-sampling kit to check for high-risk HPV, the virus that can cause cervical cancer. Researchers will track 300 women aged 30-65 to see how many have HPV and if the self-test is acceptable. The goal is to make cervical cancer screening easier for those with chronic immune conditions.

What this could mean

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

Active substance
vaginal self-sampling for HPV detection
What this could lead to
If successful, this could offer a more accessible and comfortable way for women with immune diseases to screen for cervical cancer.
What could go wrong
This is an observational study, not a treatment trial. It only measures HPV prevalence and screening uptake, so it won't directly improve health outcomes.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

278 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 2026

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.

Ages

30 to 65 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: Prospective and retrospective patient * Women aged 30 to 65 years old * presenting with MSIA, MSIA includes Systemic lupus erythematosus Sjögren's syndrome Systemic scleroderma Mixed connective tissue disease Inflammatory myositis Systemic sarcoidosis Systemic vasculitis Behçet's disease Adult-onset Still's disease IgG4-related disease Autoimmune cytopenia (autoimmune hemolytic anemia, immune thrombocytopenic purpura, Evans syndrome) Susac syndrome * Followed in the internal medicine department of Bichat Hospital, Paris * Not up to date with gynecological follow-up (i.e., Pap smear more than one year old or undatable) (for retrospective patients: at the time of initial screening) Retrospective patient \- Patient who underwent Pap smear screening less than one year before the start of the study Exclusion Criteria: Prospective and retrospective patient * Patient under legal protection, guardianship, or trusteeship * History of colpohysterectomy * Not affiliated with a social security scheme (general or CMU) * Absence of informed and written consent

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Conditions

The condition(s) this trial relates to.

human papilloma virus infection

As listed by the trial registrant

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

HPV infection Systemic disease

Contacts and locations

Locations

  • Service de Médecine Interne - Hôpital Bichat Claude Bernard

    Paris, 75018, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.