Home-based Cervical Cancer Screening Project

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Other: Experimental
* Other: Active comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms randomised controlled cluster trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: home-based<br>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<br>* Counseling on cervical cancer screening followed by home-based HPV self-sampling test proposal.<br>|
| Active Comparator: hospital-based<br>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<br>* Counseling on cervical cancer screening followed invitation to screen at Dschang District Hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 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. | 2 years | 
| Cost of each screening strategy. | The cost of each strategy and make a cost-effectiveness analysis. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, human papillomavirus, screening, home-based