Home-based Cervical Cancer Screening Project (CASAHO)

Prof. Patrick Petignat

Status: Completed

Conditions: Cervical Cancer

Treatments: Other: Active comparator; Other: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT06166420

N°2022/10/1494/CE/CNERSH/SP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,079 patients

Sex: Female

Ages: 30 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,079 participants in 2 patient groups

home-based

Experimental group

Description:

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.

Treatment:

Other: Experimental

hospital-based

Active Comparator group

Description:

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.

Treatment:

Other: Active comparator