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Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial

Nature Medicine volume 29, pages 927–935 (2023)Cite this article

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Abstract

Effective approaches to improve coverage of self-collected human papillomavirus (HPV)-based cervix screening (SCS) as well as attendance at treatment for HPV-positive participants are needed to inform policy on optimal integration of cervical cancer screening programs within existing infrastructure in low-resource settings. ASPIRE Mayuge was a pragmatic cluster-randomized trial in rural Mayuge district, Uganda, comparing the superiority of two recruitment implementation strategies for SCS: Door-to-Door versus Community Health Day. Villages were randomized (unblinded) to a strategy, and participants aged 25–49 years with no previous history of hysterectomy or treatment for cervical cancer or pre-cancer were eligible. Participants completed a survey and participated in SCS. The primary outcome was rate of attendance at treatment after a positive SCS. The trial randomized 31 villages and 2,019 participants included in these analyses (Door-to-Door: 16 clusters, 1,055 participants; Community Health Day: 15 clusters, 964 participants). Among HPV-positive participants, attendance at treatment rates were 75% (Door-to-Door) and 67% (Community Health Day) (P = 0.049). Participants in the Community Health Day intervention were less likely to attend treatment compared to Door-to-Door (risk ratio = 0.78, 95% confidence interval: 0.64–0.96). No adverse events were reported. Policymakers in low-resource settings can use these results to guide implementation of SCS programs. ISRCTN registration: 12767014. ClinicalTrials.gov registration: NCT04000503.

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Fig. 1: Door-to-Door screening and results dissemination study activities.
Fig. 2: Community Health Day mobilization, screening and results dissemination study activities.
Fig. 3: CONSORT diagram for cluster-randomized trials.

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Data availability

Data access for the ASPIRE Mayuge trial, restricted to non-identifying data owing to privacy concerns, can be requested only for scientific purposes from the corresponding or senior authors, who will handle all requests. Either data will be shared through an institutional data sharing agreement or arrangements will be made for analyses to be conducted remotely without the necessity for data transfer.

The study protocol can be found in ref. 28.

Code availability

The underlying code for the results detailed in this manuscript can be requested for scientific purposes only from the corresponding or senior authors, who will handle all requests. If the request is deemed scientifically appropriate, code will be shared through a secure file transfer process.

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Acknowledgements

We would like to acknowledge the contributions of the staff at UCI who assisted in the setup of the trial as well as local laboratory managers, hub riders, Kigandalo Health Center hospital administrations and members of the village health teams. This work was supported by a Canadian Health Research Institutes Foundation grant awarded to G.O. (CIHR FDN-143339). The funding source had no direct role in study design or interpretation of results and did not contribute to writing or editing publications.

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Author notes

  1. These authors jointly supervised this work: Carolyn Nakisige, Gina Ogilvie.

Authors and Affiliations

  1. BC Women’s Hospital and Health Center, Women’s Health Research Institute, Vancouver, British Columbia, Canada

    Anna Gottschlich, Beth A. Payne, Jessica Trawin, Arianne Albert, Sheona Mitchell-Foster, Nadia Mithani, Laurie W. Smith & Gina Ogilvie

  2. University of British Columbia, Faculty of Medicine, Vancouver, British Columbia, Canada

    Anna Gottschlich, Beth A. Payne, Angeli Rawat, Joel Singer, Dirk van Niekerk & Gina Ogilvie

  3. National Cancer Institute, Bethesda, MD, USA

    Jose Jeronimo

  4. Northern Medical Program, University of British Columbia, Prince George, British Columbia, Canada

    Sheona Mitchell-Foster

  5. Uganda Cancer Institute, Kampala, Uganda

    Ruth Namugosa, Priscilla Naguti, Jackson Orem & Carolyn Nakisige

  6. BC Centre for Disease Control, Vancouver, British Columbia, Canada

    Heather Pedersen

  7. World Health Organization, Geneva, Switzerland

    Princess Nothemba Simelela

  8. BC Cancer Agency, Vancouver, British Columbia, Canada

    Laurie W. Smith & Dirk van Niekerk

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Contributions

A.G. (formal analysis, writing—original draft, writing—review and editing); B.A.P. (data curation, investigation, writing—review and editing); J.T. (formal analysis, visualization, writing—original draft, writing—review and editing); A.A. (formal analysis, writing—review and editing); J.J. (conceptualization, writing—review and editing); S.M.F. (conceptualization, writing—review and editing); N.M. (project administration, writing—review and editing); R.N. (project administration, writing—review and editing); PN (project administration, writing—review and editing); J.O. (conceptualization, writing—review and editing); H.P. (methodology, writing—review and editing); A.R. (methodology, writing—review and editing); P.N.S. (conceptualization, writing—review and editing); J.S. (conceptualization, methodology, writing—review and editing); L.W.S. (conceptualization, writing—review and editing); D.V.N. (conceptualization, writing—review and editing); C.N. (conceptualization, project administration, writing—review and editing); and G.O. (conceptualization, funding acquisition, writing—review and editing).

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Correspondence to Anna Gottschlich.

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Nature Medicine thanks Muluken Gizaw, Bhaskar Thakur and the other, anonymous, reviewer(s) for their contribution to the peer review of this work. Primary Handling Editor: Ming Yang, in collaboration with the Nature Medicine team.

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Extended data

Extended Data Table 1 HPV genotypes positivity rates (n = 2,006)a
Full size table
Extended Data Table 2 Endline cervical cancer knowledge and trial experience by trial arm
Full size table
Extended Data Table 3 Healthcare-seeking behavior during the COVID-19 pandemic (Community Health Day; n = 375)
Full size table

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Gottschlich, A., Payne, B.A., Trawin, J. et al. Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial. Nat Med 29, 927–935 (2023). https://doi.org/10.1038/s41591-023-02288-6

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