An interventional study of Community co-produced action and Standard screening strategy in Cervical Cancer Screening, sponsored by Prof. Patrick Petignat. Active, not recruiting at 1 site in Cameroon. Open to female participants aged 25 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Prof. Patrick Petignat · Not applicable, Interventional, and Screening
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 800 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Prof. Patrick Petignat is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Community co-produced action
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.
Other: Standard screening strategy
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.
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.
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.
Time frame: 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.
Number of women having completed primary screening
Rate of primary screening (HPV test) among the eligible population in both study arms.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At enrollment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol
Time frame: Upon result publication and for a minimum of 10 years.
Access criteria: The anonymized IPD will be made available on an open-access data repository.
Data sharing details ↗ · yareta.unige.ch
Ran from Apr 2024 to primary completion in May 2026, 25 months.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's 25 months is below that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Prof. Patrick Petignat