Clinical trial NCT06166420: Home-based Cervical Cancer Screening Project
Official title: Offering Home-based Versus Hospital-based HPV Counseling and Testing for Cervical Cancer Screening in Rural West Region of Cameroon: a Randomised Cluster Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
human papillomavirus
screening
home-based
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Dschang District Hospital
First posted: 2023-12-12
Enrollment: 2079
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms randomised controlled cluster trial
Primary purpose: SCREENING

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.

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).

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

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Number and percentage of women who will do an HPV test within 3 months of sensitization per study arm
timeFrame: 3 months from sensitization
measure: 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.
timeFrame: 3 months from HPV self sample collection
measure: Identify barriers and enablers to the home-HPV self-sampling test.
timeFrame: 4 months
measure: Identify barriers and enablers of linkage to VIA for HPV positive women
timeFrame: 4 months
measure: Number of pre-cancers and/or cancers diagnosed in each study arm.
timeFrame: 2 years
measure: Cost of each screening strategy.
timeFrame: 2 years
Other outcomes:
Locations:
city: Dschang
country: Cameroon
facility: Dschang District Hospital
state: Menoua
Study officials:
affiliation: University Hospital, Geneva
name: Patrick Petignat, Pr
role: PRINCIPAL_INVESTIGATOR
References: