Self-sampling for Non-participants in an Organised Cervical Cancer Screening Programme

NCT02680262 | Completed DMC

• 1 other identifier: af_randers
• Study Type: interventional
• Target: 9,327
• Locations: 1 country
• Sites: 1

Brief Summary

The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.

Conditions

Cervical Cancer

Keywords

HPV self-sampling, cervical cancer screening

Outcome Measures

Primary Outcomes (1)

• Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.

  Primary outcome will be the proportion of women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.

  90 days

Secondary Outcomes (1)

• Women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out.

  30,60 or 90 days

Study Arms (3)

Intervention group 1

EXPERIMENTAL

HPV self-sampling kit mailed directly

Behavioral: HPV self-sampling kit mailed directly

Intervention group 2

EXPERIMENTAL

HPV self-sampling kit on demand

Behavioral: HPV self-sampling kit on demand

Intervention group 3

EXPERIMENTAL

second reminder

Behavioral: Second reminder

Interventions

HPV self-sampling kit mailed directly BEHAVIORAL

Women in intervention group 1 will be mailed a modified second reminder, a leaflet entitled Information about HPV self-sampling, and a self-sampling kit. The leaflet provides information about HPV and cervical cancer including benefits and harms about HPV self-sampling compared to regular screening. The kit includes a brush device (Evelyn Brush, Rovers Medical Devices B.V, Oss, Netherlands) to collect a cervico-vaginal sample for subsequent hrHPV testing, written and drawn instructions on how to obtain and mail the sample, and a pre-stamped return envelope addressed to the Department of Pathology, Randers Regional Hospital performing the hrHPV testing.

Intervention group 1

HPV self-sampling kit on demand BEHAVIORAL

Women in intervention group 2 receive the same material as arm 1, except for the kit, which will only be mailed to the women on demand. Additionally, the leaflet for this group contains information on how to order the kit. The modified second reminder in both intervention groups informs of the opportunity to collect a self-sample if wanted, but also about the opportunity to have a conventional specimen taken at a general practitioner (usual procedure).

Intervention group 2

Second reminder BEHAVIORAL

The standard second reminder informs women about the ongoing opportunity to have a conventional cervical sample taken by a general practitioner. (control group)

Intervention group 3

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women resident in the Central Denmark Region who have not participate in cervical cancer screening after an invitation and one reminder

You may not qualify if:

• Women younger than 30 years are not included due to the lower specificity of HPV DNA tests in younger women

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Mette Tranberg Nielsen

Randers, Randers NØ, 8930, Denmark

Location

Related Publications (3)

• Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. HPV self-sampling in cervical cancer screening: the effect of different invitation strategies in various socioeconomic groups - a randomized controlled trial. Clin Epidemiol. 2018 Aug 23;10:1027-1036. doi: 10.2147/CLEP.S164826. eCollection 2018.

  PMID: 30197540 DERIVED

• Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. Preventing cervical cancer using HPV self-sampling: direct mailing of test-kits increases screening participation more than timely opt-in procedures - a randomized controlled trial. BMC Cancer. 2018 Mar 9;18(1):273. doi: 10.1186/s12885-018-4165-4.

  PMID: 29523108 DERIVED

• Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program. BMC Cancer. 2016 Nov 3;16(1):835. doi: 10.1186/s12885-016-2859-z.

  PMID: 27809810 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mette Tranberg Nielsen, Phd Student

  Department of Public Health Programmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 11, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: February 1, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)