Home-based Cervical Cancer Screening Project

NCT06166420 | Completed DMC

• 1 other identifier: N°2022/10/1494/CE/CNERSH/SP
• Study Type: interventional
• Target: 2,079
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical cancer is a public health problem in Cameroon.In 2020, the country had a crude incidence of 20.2 per 100 000 women for an incidence to mortality ratio of 0.65. As for now, the country does not have a national screening program to combat the disease. Only 6% of cameroonian women have once been screened for cervical cancer. In order to increase screening uptake so as to reach 70% recommended by the World Health Organization (WHO), a home-based cervical cancer screening approach is proposed. The objective of our study is to compare two recruitment strategies for cervical cancer screening in rural Cameroon.

Conditions

Cervical Cancer

Keywords

cervical cancer; human papillomavirus; screening; home-based

Outcome Measures

Primary Outcomes (1)

• Number and percentage of participants who will complete full screening (HPV test +/- VIA/VILI +/- treatment when necessary) in both arms within 3 months of sensitization

  The number and percentage of participants who will do an HPV self test+/- VIA/VILI+/- treatment par study arm

  3 months

Secondary Outcomes (6)

• Number and percentage of women who will do an HPV test within 3 months of sensitization per study arm

  3 months from sensitization

• Number and percentage of participants once tested HPVpositive who will link to the pelvic exam for visual assessment and treatment (if needed) within 3 months.

  3 months from HPV self sample collection

• Identify barriers and enablers to the home-HPV self-sampling test.

  4 months

• Identify barriers and enablers of linkage to VIA for HPV positive women

  4 months

• Number of pre-cancers and/or cancers diagnosed in each study arm.

  2 years

Study Arms (2)

home-based

EXPERIMENTAL

A team made up of a Community Health Worker (CHW) and a nurse will do door-to-door sensitization and propose to eligible women to undergo HPV self-sampling test at home. Samples collected will be taken by the nurse to the hospital for HPV testing . Participants will receive a phone call: disclosure of the HPV test's result will be by phone call for HPV-negative participants; HPV-positive participants will be invited to the hospital for disclosure of their results. At the hospital, HP-positive participants will undergo visual assessment of their cervix and treatment if needed.

Other: Experimental

hospital-based

ACTIVE COMPARATOR

Community Health Worker (CHW) will do door-to-door sensitization and invite eligible women to attend cervical cancer screening at District Hospital Dschang. At the hospital they will do HPV self-sampling test. HPV-negative women will be advised to repeat the test after 5 years while HPV positive women will undergo visual assessment of the cervix with acetic acid and lugol (VIA/VILI) and treatment if needed.

Other: Active comparator

Interventions

Experimental OTHER

Counseling on cervical cancer screening followed by home-based HPV self-sampling test proposal.

home-based

Active comparator OTHER

Counseling on cervical cancer screening followed invitation to screen at Dschang District Hospital.

hospital-based

Eligibility Criteria

• Age: 30 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 30-49 years
• Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).
• Pregnancy at the time of screening
• History of cervical cancer screening by HPV test of less than 5 years (for HIV-negative women) or less than 3 years (for HIV positive women).
• Intra-vaginal treatment

You may not qualify if:

• Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
• Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)
• Women who are not able to comply with the study protocol.
• Previous hysterectomy
• Known cervical cancer

Sponsors & Collaborators

• Prof. Patrick Petignat: lead
• Dschang District Hospital: collaborator

Study Sites (1)

Dschang District Hospital

Dschang, Menoua, Cameroon

Location

Related Publications (1)

• Moukam AMD, Salah N, Tankeu Happi GW, Metchehe LDD, Makajio SL, Wisniak A, Sormani J, Kenfack B, Vassilakos P, Socpa A, Petignat P, Schmidt NC. Acceptability of home-based HPV self-sampling for cervical cancer screening among users and providers in the West region of Cameroon: a cross-sectional study. BMC Health Serv Res. 2025 Oct 3;25(1):1303. doi: 10.1186/s12913-025-13467-1.

  PMID: 41044580 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

• Patrick Petignat, Pr

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Two arms randomised controlled cluster trial

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: March 27, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

CA (1)