Community-Integrated Self-Collection HPV-Based Cervix Screening Programs to Increase Screening and Treatment Coverage: Results from a Pragmatic, Cluster-Randomized Trial

Background: The WHO’s cervical cancer elimination strategy calls for 70% screened and 90% with cervical disease treated. Human papillomavirus (HPV) testing increases access to cervix screening, improving screening and treatment uptake. Self-collection screening is acceptable and feasible. However, data are needed to inform policy on how health systems can best integrate self-collection HPV-based screening programs within existing infrastructure to optimize screening and treatment coverage.Methods: ASPIRE Mayuge was a pragmatic cluster-randomized trial in Uganda comparing implementation strategies for self-collection screening: door-to-door and community health days. Villages were randomized to strategy. Participants ages 25-29 with no prior cervix treatment were eligible. Participants completed a survey and self-collection screening. The primary outcome was follow-up attendance at local health centers after a positive screen. We ran mixed-effects logistic regression models to compare outcomes between arms.Findings: A total of 31 villages and 2,019 participants were randomized (Arm 1: 16 clusters, 1055 participants; Arm 2: 15 clusters, 964 participants). Among HPV positive participants, follow-up attendance rates were 75% (Arm 1) and 66% (Arm 2). The adjusted regression model showed Arm 2 had lower odds of follow-up attending (OR = 0·67, 95% CI: 0·38-1·19).Interpretation: Both models were feasibly integrated into existing infrastructure and led to high rates of follow-up attendance. The door-to-door model, with individualized education, may encourage better follow-up attendance; however, community health days required fewer personnel and allowed for bundling of services. Jurisdictions can use this trial as a roadmap for implementation and determine which approach is best suited for their setting.Trial Registration Details: ISRCTN, ISRCTN12767014. Registered 14 May 2019, https://doi.org/10.1186/ISRCTN12767014; clinicaltrials.gov, NCT04000503; Registered 27 June 2019, https://clinicaltrials.gov/ct2/show/NCT04000503.Funding Information: This work was supported by a Canadian Health Research Institutes Foundation grant awarded to Professor Gina Ogilvie (CIHR FDN-143339).Declaration of Interests: No conflicts of interest exist.Ethics Approval Statement: Ethics approval was obtained from the University of British Columbia / Children’s and Women’s Health Centre of British Columbia Research Ethics Board (UBC C&W REB # H17–0333) and the Uganda Cancer Institute (UCIREC REF-02-2018). All study participants provided informed consent.