Cervical Cancer ScreeningAct4CCNCT06640075
Community Co-produced Action for Improved Access to Cervical Cancer Screening in Cameroon
A study testing Community co-produced action and Standard screening strategy in people with Cervical Cancer Screening, run by Prof. Patrick Petignat at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Community co-produced action and Standard screening strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteCameroon
- Study dates
- 13 Apr 2024to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Cervical Cancer Screening
- Being tested
- Community co-produced action, Standard screening strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community co-produced actionOther
Participatory workshops will be conducted with community members by a multidisciplinary team with the aim to co-develop a strategy for cervical cancer screening adapted to the local setting (including primary HPV screening, triage of HPV-positive patients and treatment of patients triaged positive). This intervention is referred to as 'community co-produced action'. Possible strategies co-developed may include collaboration with community health workers or local associations, awareness campaigns, development of health education materials, integration of primary HPV screening at local integrated health centers, organization of group transportation to the district screening center, etc.
Using purposive sampling methods, approximately 15 participants will be invited to take part in the workshops in each health area of the intervention, including approximately 3 health care providers, 3 community health workers or members of women's associations, 3 men and 6 eligible women for screening.
Standard screening strategyOther
Recruitment of study participants will be coordinated centrally at district level (from the Bafoussam Regional Hospital) following procedures previously established in a cervical cancer screening program in the health district of Dschang. This standard procedure includes the training of 2 community health workers (CHW) by health area to raise awareness around cervical cancer. After an initial theoretical and practical training in cervical cancer prevention, CHWs recruit women by going door-to-door or through community meetings in their respective health areas. Through a system of nominal invitation vouchers distributed to eligible women, CHWs receive a financial incentive for each woman that shows up for cervical cancer screening. Twice a year, CHWs of all health areas are invited to a feedback session to discuss difficulties encountered on the field and propose solutions to face any identified challenges.
| Study group | Role | What they receive |
|---|---|---|
| Community co-produced action | Experimental | Participatory workshops will be conducted with community members by a multidisciplinary team with the aim to co-develop a strategy for cervical cancer screening adapted to the local setting (including primary HPV screening, triage of HPV-positive patients and treatment of patients triaged positive). Receives: Other: Community co-produced action |
| Standard screening strategy | Active comparator | Recruitment of study participants will be coordinated centrally at district level (from the Bafoussam Regional Hospital) following procedures previously established in a cervical cancer screening program in the health district of Dschang. Receives: Other: Standard screening strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women having completed screening for cervical cancer
Complete screening (defined as an HPV test +/- triage for HPV-positive women) among the eligible population in both study arms.
Measured: HPV test within 12 months after implementation of the screening strategy at health-area level, and triage within 6 months of the HPV test if positive.
Secondary outcomes (4)
Number of women having completed primary screening
Rate of primary screening (HPV test) among the eligible population in both study arms.
Measured: Within 12 months after implementation of the screening strategy at health-area level
Number of HPV-positive women having completed triage and treatment when necessary
Proportion of women with positive primary screening who proceed to completing triage and treatment (when needed) in both study arms
Measured: Within 6 months after primary screening (HPV test)
Number of HPV-positive women attending a follow-up visit at 12 months
Proportion of HPV-positive women who attend the follow-up visit at 12 months after primary screening (HPV test) in both study arms
Measured: From 11 to 15 months after primary screening
Number of women with different sociodemographic characteristics
Distribution of sociodemographic characteristics among screened women in both study arms
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start13 Apr 2024
- Primary completion21 May 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster-randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Patrick Petignat
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Bafoussam Regional Hospital, Cameroon, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor-investigator, Prof. Patrick Petignat, University Hospital, Geneva
- Investigators
- Patrick Petignat, PD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640075
- Sponsor's protocol ID
- 1020/31/01/2024/CE/CRERSH-OU/V
- Other IDs
- AO_2023-00019
- Acronym
- Act4CC
- Status last verified
- Aug 2026
- First submitted
- 10 Oct 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized IPD will be made available on an open-access repository alongside a data dictionary. All IPD used in the results publication will be published.