Home-based Cervical Cancer Screening Project

NCT ID: NCT06166420

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2079 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2024-08-31

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.

Detailed Description

In 2018, a 5 years cervical cancer screening project called: "Promoting Comprehensive Cervical Cancer Prevention and Better Women's Health in Low- and Medium Resource Settings in the Health District of Dschang" was launched in the West Region of Cameroon. The study aimed at screening 2000 women per year following screen-triage-treatment as recommended by WHO in a 3T approach: Test with HPV self-sampling test, Triage by visual assessement of the cervix with acetic acid and lugol (VIA/VILI), Treatment with thermal ablation. Despite sensitization using communication information channels, uptake of the screening was below the target. In order to increase uptake of the screening, this study proposes a home-based strategy using Community Health Workers (CHW). Community Health Workers (CHW) are lay members of the community who carry out health promotion activities after training. In a randomised controlled cluster trial, two recruitment strategies for cervical cancer screening will be compared: in one arm a team made up of a CHW and a nurse will do door-to-door sensitization and propose home-based HPV self-sampling test to eligible women and in the other arm CHW will do door-to-door sensitization and issue invitation cards to eligible women for hospital-based HPV self-sampling test. This study is nested in ongoing cervical cancer screening project.

Primary objective: To compare completeness of full screening between two different recruitment strategies in rural area: counselling and home-based HPV self-sampling test versus counselling and hospital-based HPV self-sampling test.

Secondary objectives:

• To determine the proportion of women who will carry out an HPV self-sampling test in both strategies within 3 months of sensitization.
• To determine the proportion of HPV positive women who will undergo VIA/VILI in both arms within 3 months.
• To assess the acceptability of home self-sampling HPV test and perception of single versus 2 visits approaches.
• To determine predictors of non-adherence to care-seeking for HPV positive women.
• To determine the number of pre-cancers and/or cancers diagnosed in both arms and their treatment.
• To calculate the economic cost of both strategies.

Mixed method design, quantitative and qualitative informations will be collected.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

home-based

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.

Group Type: EXPERIMENTAL

Experimental

Intervention Type: OTHER

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

hospital-based

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.

Group Type: ACTIVE_COMPARATOR

Active comparator

Intervention Type: OTHER

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

Interventions

Experimental

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

Intervention Type: OTHER

Active comparator

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dschang District Hospital

UNKNOWN

Sponsor Role: collaborator

Prof. Patrick Petignat

OTHER

Sponsor Role: lead

Responsible Party

Prof. Patrick Petignat

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Patrick Petignat, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Dschang District Hospital

Dschang, Menoua, Cameroon

Countries

Cameroon

References

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.

Reference Type: DERIVED

PMID: 41044580 (View on PubMed)

Other Identifiers

N°2022/10/1494/CE/CNERSH/SP

Identifier Type: -

Identifier Source: org_study_id