Home-based Cervical Cancer Screening Project

Cervical Cancer Clinical Trial

— CASAHO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166420
• Other study ID #: N°2022/10/1494/CE/CNERSH/SP
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Geneva
• Contact: Patrick Petignat, Pr
• Phone: +41796630546
• Email: patrick.petignat[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• Experimental
Counseling on cervical cancer screening followed by home-based HPV self-sampling test proposal.
• Active comparator
Counseling on cervical cancer screening followed invitation to screen at Dschang District Hospital.

Locations

Country	Name	City	State
Cameroon	Dschang District Hospital	Dschang	Menoua

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Patrick Petignat	Dschang District Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost of each screening strategy.	The cost of each strategy and make a cost-effectiveness analysis.	2 years