Clinical trial NCT06640075: Community Co-produced Action for Improved Access to Cervical Cancer Screening in Cameroon
Official title: Co-produced Community Action for Improved Access to Cervical Cancer Screening (Act4CC): a Mixed-methods Study in Rural Areas of the Mifi Health District
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer Screening
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: Bafoussam Regional Hospital, Cameroon
name: London School of Hygiene and Tropical Medicine
First posted: 2024-10-15
Enrollment: 800
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster-randomized controlled trial
Primary purpose: SCREENING

Brief summary: Background - The burden of cervical cancer is unequally distributed globally, with over 90% of deaths occurring in low- and middle-income countries (LMICs), mainly due to insufficient uptake of preventive measures such as screening. In 2020, the World Health Organization launched a global initiative for the worldwide elimination of cervical cancer as a public health issue, setting a target of 70% of women screened with a high-performance test. In Cameroon, this target is far from being reached, and rural communities are disproportionately affected by low uptake of screening services. Recently, a new cervical cancer screening program has launched in the Bafoussam Regional Hospital, in the capital of the Mifi Health District, as part of a larger research project. To develop a context-specific strategy improving access to screening for women living in rural areas of the district, the active participation of community members for the co-development and implementation of local strategies for cervical cancer screening may be key to improving population screening coverage.

Objective - The aim of this study is to evaluate the use of community co-produced action (CCA) for the development and implementation of HPV-based cervical cancer screening strategies compared to a traditional hospital-based approach in rural areas of the Mifi Health District in Cameroon.

Methods - Using a cluster-randomized study design, participatory workshops with community members will be led in 7 rural health areas assigned to the intervention arm, with the aim of codeveloping local strategies for HPV-based cervical cancer screening adapted to the setting. The co-produced strategies may include raising awareness among eligible women (aged 30-49 years, or 25-49 years if HIV-positive), as well as facilitating access to screening tests, results and follow-up. Women living in one of the 7 health areas assigned to the control arm will be invited by community health workers to undergo screening at the Bafoussam Regional Hospital. In both study arms, screened women will be included in the GENOVA study, a cervical cancer screening trial offering free-of- charge HPV testing followed by triage by visual inspection or genotyping for HPV-positive women, and free treatment according to triage results. CCA will be evaluated by assessing its effectiveness for screening uptake. Screening coverage among eligible women will be estimated during one year after implementation of screening strategies in both study arms, based on population statistics provided by the Mifi health district for each health area.

Expected results - Developing context-sensitive solutions to cervical cancer screening through a community-based participatory approach in rural areas of the Mifi health district is expected to improve screening participation rate.


Eligibility criteria: Inclusion Criteria:

* Women aged 30-49 years old (25-49 years old if HIV-positive)
* Residency in one of the 14 rural health areas of Mifi health district
* Ability to give signed informed consent

Exclusion Criteria:

* known cervical cancer
* symptoms compatible with cervical cancer
* previous hysterectomy
* terminal disease other than cervical cancer
* cervical cancer screening test in the last 5 years (3 years if HIV-positive)
* pregnancy at the time of screening
* lack of discernment capacity

Primary outcomes:
measure: Number of women having completed screening for cervical cancer
timeFrame: Within 12 months after implementation of the screening strategy at health-area level
Secondary outcomes:
measure: Number of women having completed primary screening
timeFrame: Within 12 months after implementation of the screening strategy at health-area level
measure: Number of HPV-positive women having completed triage and treatment when necessary
timeFrame: Within 3 months after primary screening (HPV test)
measure: Number of HPV-positive women attending a follow-up visit at 12 months
timeFrame: From 11 to 15 months after primary screening
measure: Number of women with different sociodemographic characteristics
timeFrame: At enrollment
Other outcomes:
Locations:
city: Bafoussam
country: Cameroon
facility: Bafoussam Regional Hospital
state: Mifi
Study officials:
affiliation: University Hospital, Geneva
name: Patrick Petignat, PD
role: PRINCIPAL_INVESTIGATOR
References: