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BMC Cancer. 2017 Dec 6;17(1):826. doi: 10.1186/s12885-017-3818-z.

Study protocol for a cluster-randomized trial to compare human papillomavirus based cervical cancer screening in community-health campaigns versus health facilities in western Kenya.

Author information

Duke University, Global Health Institute and Department of Obstetrics and Gynecology, 310 Trent Drive, Room 204, Durham, NC, 27708, USA.
Department of Epidemiology and Biostatistics, University of California San Francisco, Box 0560, San Francisco, CA, 94143-0560, USA.
Department of Epidemiology, University of North Carolina, 2103 McGavran-Greenberg Hall Campus, Box# 7435, Chapel Hill, NC, 27599-7435, USA.
Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, Box 1280, 560 Mission Street, 3rd Floor, San Francisco, CA, 94143, USA.
Kenya Medical Research Institute, Center for Microbiology Research, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.
Department of Obstetrics and Gynecology, University of Nairobi, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.



Despite guidelines for cervical cancer prevention in low-resource countries, a very small proportion of women in these settings undergo screening, and even fewer women are successfully treated. Using pilot data from western Kenya and World Health Organization recommendations, we developed a protocol to implement evidence-based cervical cancer screening and linkage to treatment strategies to the rural communities. We describe the protocol for a cluster-randomized trial to compare two implementation strategies for human-papillomavirus (HPV)-based cervical cancer screening program using metrics described in the RE-AIM (reach, efficacy, adaption, implementation and maintenance) framework.


The study is a three-year, two-phase cluster-randomized trial in 18 communities in western Kenya. During Phase 1, six control communities were offered screening in health facilities; and six intervention communities were offered screening in community health campaigns. Screening was done with human-papillomavirus testing through self-collected specimens. Phase 1 ended and we are working in partnership with communities to further contextualize the implementation strategy for screening, and develop an enhanced linkage to treatment plan. This plan will be tested in an additional six communities in Phase 2 (enhanced intervention). We will compare the reach, efficacy, cost-effectiveness and adaptability of the implementation strategies.


Effective low-cost cervical cancer prevention technologies are becoming more widely available in low- and middle-income countries. Despite increasing government support for cervical cancer prevention, there remains a sizeable gap in service availability. We will use implementation science to identify the most effective strategies to fill this gap through development of context-specific evidence-based solutions. This protocol design and results can help guide implementation of cervical cancer screening in similar settings, where women are most underserved and at highest risk for disease.


This trial is registered at , NCT02124252 .


Cervical cancer screening; Community health campaigns; HPV self-collection; Implementation science; Kenya

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