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Trials / Completed

CompletedNCT06166420

Home-based Cervical Cancer Screening Project

Offering Home-based Versus Hospital-based HPV Counseling and Testing for Cervical Cancer Screening in Rural West Region of Cameroon: a Randomised Cluster Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,079 (actual)
Sponsor
Prof. Patrick Petignat · Academic / Other
Sex
Female
Age
30 Years – 49 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERExperimentalCounseling on cervical cancer screening followed by home-based HPV self-sampling test proposal.
OTHERActive comparatorCounseling on cervical cancer screening followed invitation to screen at Dschang District Hospital.

Timeline

Start date
2023-03-27
Primary completion
2024-08-31
Completion
2024-08-31
First posted
2023-12-12
Last updated
2025-01-15

Locations

1 site across 1 country: Cameroon

Source: ClinicalTrials.gov record NCT06166420. Inclusion in this directory is not an endorsement.