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Comparative Study
. 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

Megan J Huchko  1 , James G Kahn  2 , Jennifer S Smith  3 , Robert A Hiatt  2 , Craig R Cohen  4 , Elizabeth Bukusi  5   6
Affiliations
Comparative Study

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

Megan J Huchko et al. BMC Cancer. .

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: This trial is registered at ClinicalTrials.gov , NCT02124252 .

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

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Conflict of interest statement

Ethics approval and consent to participate

The KEMRI Scientific and Ethics Review Unit (SERU; #2918), the Duke University Institutional Review Board (Pro0007742) and and the University of California San Francisco (UCSF) Human Research Protection Program Institutional Review Board (14–13,698) reviewed and approved the study. All participants gave their written informed consent to participate in the study prior to data or specimen collection.

Consent for publication

Not Applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Two-phase cluster-randomized trial design
Fig. 2
Fig. 2
Map of communities randomized to control and intervention activities in Migori, County Kenya. This map was developed by Easter Olwanda, who has provided written permission for use in this publication
Fig. 3
Fig. 3
Quantitative process measures for four aspects of cervical cancer prevention program delivery
See this image and copyright information in PMC

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