Health TrialsbyHealthPanel

HPV Self-sampling in the General Population

ConditionCervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorInternational Agency for Research on Cancer

About this trial

A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit ("Outreach" arm), choice between self-sampling or healthcare provider sampling ("Choice" arm), and standard care (control arm) in two French departments.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women aged 30 to 65 years old

Living in the study area (Departments of Marne and Aube, France)

At moderate risk of cervical cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)

Disqualifiers

Outside the target age (less than 30 years old, or 66 years old and more)

Already participating in the current screening round

Total hysterectomy

History of cervical cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Women receive invitation letter with HPV self-sampling kit

    Other intervention

    Direct mailing of HPV self-sampling kit. Women receive HPV self-sampling kit with instructions. SMS reminder at 3 months if no participation. Assistance provided for triage cytology if HPV positive.

  • Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider

    Other intervention

    Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.

Treatment groups

6,000 Participants
are divided into 3 treatment groups
Group A: OutreachExperimental treatment 1 intervention
Group B: ChoiceExperimental treatment 1 intervention
Group C: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Participation rate in cervical cancer screening

Time frame
18 months after invitation

Secondary outcomes

1

Triage cytology completion rate after positive HPV test

Time frame
6 months after positive result
2

HPV positivity rate

Time frame
12 months after invitation
3

Invalid result rate

Time frame
18 months
4

Time from HPV-positive result to completion of cytological triage

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Agency for Research on Cancer

Lead sponsor

National Cancer Institute, France

Collaborator

Central Hospital, Nancy, France

Collaborator

CHU de Reims

Collaborator

Source ClinicalTrials.gov
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