Community-led cervical cancer screening program in assigned female at birth people living in precarious conditions in Geneva: a stepped-wedge randomized controlled trial
Description: BackgroundAssigned female at birth (AFAB) people living in precarious conditions (PC) face higher Human Papillomavirus (HPV)-related precancerous lesions risks but lower screening, diagnosis, and treatment rates. Primary high-risk HPV (hr-HPV) testing is considered a first-line strategy for cervical cancer (CC) screening. HPV self-collection testing shows comparable accuracy to clinician sampling and enables unsupervised testing particularly relevant for hard-to-reach populations. Mailed HPV self-collection testing, compared to scheduling assistance alone, has increased CC screening uptake among under-screened women in the USA. The literature also suggests the effectiveness of community workers in improving cancer prevention, yet further research is required to evaluate the benefits of community support in addition to the distribution of HPV self-sampling kits in diverse AFAB populations . Evaluating the impact throughout the entire care pathway, from screening to diagnosis and linkage to care, remains essential. ObjectivesObjective 1: To evaluate the acceptability, feasibility, and effectiveness of a community-based model of care using HPV self-sampling kits, and pap-smear for those identified hr-HPV positive, to screen, diagnose and treat HPV-related precancerous lesions in AFAB people living in PC in Geneva. Objective 2: To assess whether the support from a community worker in this community model using a tailored information/counselling toolkit will increase hr-HPV screening, PAP smear uptake and linkage to care as compared to a simple mailed HPV self-collection testing strategy. Objective 3: To assess the cost-effectiveness of the 2 strategies.MethodsThe study will include AFAB individuals aged 21–70 living in PC, including unstable employment, insecure residency status, economic hardship, and housing instability.A stepped wedge randomized controlled trial will be designed to assess the impact of a community support in addition to a simple mailed HPV self-collection testing strategy. The project will rely on a strong community network of Geneva associations.HPV self-collection kits will be distributed in each association at the beginning of the trial. Participants will be offered to perform the hr-HPV self-collection swab either at home or directly in the partner association. The intervention will involve implementing an HPV information/counselling toolkit within each partner association, accompanied by targeted training for community workers. Developed through prior consultative meetings with community workers and peer educators, the modular toolkit will aim to deliver clear, comprehensive, and tailored information on HPV screening, diagnosis, care, and treatment to AFAB individuals. It will include: i) key knowledge on HPV-related lesions, prevention, diagnosis, and treatment; ii) communication strategies and tools; and iii) stage-specific messages along the care pathway. Trained community workers will use the toolkit to conduct Information, Education, and Communication activities and provide support throughout the women's care continuum.Associations will be randomly allocated to cross over to the intervention condition, at different times, until all are exposed to the intervention condition. The primary outcome will be the uptake of HPV diagnosis, defined as attendance at a Papanicolaou–HPV co-testing appointment or testing negative for hr-HPV on self-collected samples in a maximum timing of 3 months among all AFAB individuals receiving an HPV self-collection kit.Samples will undergo testing using the Xpert HPV assay. Hr-HPV-positive participants will be invited for a free Papanicolaou–HPV co-testing appointment. Participants identified with precancerous lesions will be referred to the gynaecology department of Geneva University Hospitals for further clinical investigations.Quantitative and qualitative methods will be used to evaluate the community-led model’s acceptability, efficiency, and feasibility. Knowledge, attitudes and practices questionnaires regarding HPV infection will be documented. An ethnographic survey will be carried out throughout the study to analyse the experiences and perceptions of participants and community workers. At the end of the project, a qualitative evaluation will assess the perception and acceptability of the model. Semi-structured interviews will be conducted with a sample of 20 AFAB individuals using a purposive sampling approach to ensure sample diversification. Costs will be estimated using both a societal and healthcare system approach encompassing all costs, direct and indirect.
Amount: CHF 4,380
Funding type: research
Funder scheme: IICT - PPI Preparatory Grant
Start date: 2025-07-01
End date: 2025-10-31
Investigator: Segeral, Olivier
Institution: University of Geneva – GE
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Funded outputs count: 0
Funder award ID: 238542
OpenAlex ID: G2863463653