Home-based Cervical Cancer Screening Project

Prof. Patrick Petignat2,079 enrolled

Overview

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.

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

Interventions

ExperimentalOTHER

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

Active comparatorOTHER

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

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged 30-49 years * Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF). Non-inclusion criteria: * 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

Locations (1)

Dschang District Hospital

Dschang, Menoua, Cameroon

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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

The number and percentage of participants who will do an HPV test in each arm of the study.

Time frame: 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.

The number and percentage of participants once tested HPV positive who link to the hospital for visual assessment of the cervix and treatment if needed.

Time frame: 3 months from HPV self sample collection

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

Factors that prevent and motivate women to participate to a home-based HPV self-test.

Time frame: 4 months

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

Factors that prevent and motivate participants who did a home-based HPV self-test to link to the hospital for visual assesment of the cervix using acetic acid and lugol (VIA/VILI).

Time frame: 4 months

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

The number of pre-cancers and cancers diagnosed per study arm.

Time frame: 2 years

Data from ClinicalTrials.gov

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