Abstract
BackgroundDespite 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.MethodsThe 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.DiscussionEffective 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 registrationThis trial is registered at ClinicalTrials.gov, NCT02124252.
Highlights
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
We developed a study protocol that will allow us to compare two context-specific implementation strategies for an HPV-based cervical cancer prevention program through a cluster-randomized trial of HPV-based cervical cancer screening in community-health campaigns versus health facilities using the RE-AIM framework [16, 17]
Study design and setting The study is a two-phase cluster randomized trial in western Kenya to evaluate reach, effectiveness, costeffectiveness and maintenance of two implementation strategies for a cervical cancer prevention protocol that consists of four critical, evidence-based components: (1).HPV and cervical cancer outreach and education
Summary
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. The World Health Organization (WHO) recommends alternative cervical cancer prevention techniques and protocols for low-resource countries that employ low-cost or simple-to-use screening technologies [4] One such strategy – high-risk human papillomavirus (HPV) testing– has been shown to reduce the incidence and mortality from cervical cancer when coupled with outpatient treatment for women with HPVpositive results [5]. In addition to effective screening tools, the impact of cervical cancer prevention programs depends on two main context-specific factors: (1) women’s access to screening and (2) successful acquisition of treatment for women who screen positive Access to both screening and treatment is most challenging in poor rural areas, due to geographic and infrastructure constraints [6, 7]. Despite the development of guidelines for cervical cancer screening that employed evidence-based technologies and lower resource protocols, the lack of rigorously tested, context-specific implementation strategies has left a gap between policy and practice
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