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
Open accessAbstract
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 .
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Another study in Kenya compared community campaign-based self-collection to facility-based self-collection, based on the standard screening approach in the country.
“Another study in Kenya also compared community campaign-based self-collection to facility-based self-collection, which was also based on the standard screening approach in the country.49”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Cane, J., O’Connor, D., & Michie, S. (2012) · Implementation Science · doi:10.1186/1748-5908-7-37 · Cited by 4,888 · cited 1× · see citing works
“Focus group discussions were analyzed using the theoretical domains framework, which mapped behaviors to intervention strategies, using evidencebased principles of behavior change [42].”
Method
Flagged first, then by citations
Research works printed but not linked: 40
- [1]Ferlay J Shin HR Bray F Forman D Mathers C Parkin DM Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008 International journal of cancer Journal international du cancer 2010 127 12 2893 2917 10.1002/ijc.25516 21351269 · DOI
- [2]Jemal A Bray F Center MM Ferlay J Ward E Forman D Global cancer statistics CA Cancer J Clin 2011 61 2 69 90 10.3322/caac.20107 21296855 · DOI
- [3]Sankaranarayanan R Swaminathan R Jayant K Brenner H An overview of cancer survival in Africa, Asia, the Caribbean and central America: the case for investment in cancer health services IARC Sci Publ 2011 162 257 291 21675431
- [5]Sankaranarayanan R Nene BM Shastri SS Jayant K Muwonge R Budukh AM Hingmire S Malvi SG Thorat R Kothari A HPV screening for cervical cancer in rural India N Engl J Med 2009 360 14 1385 1394 10.1056/NEJMoa0808516 19339719 · DOI · Paper page
- [6]Akinyemiju TF Socio-economic and health access determinants of breast and cervical cancer screening in low-income countries: analysis of the world health survey PLoS One 2012 7 11 e48834 10.1371/journal.pone.0048834 23155413 PMC3498259 · DOI
- [7]Anorlu RI Cervical cancer: the sub-Saharan African perspective Reprod Health Matters 2008 16 32 41 49 10.1016/S0968-8080(08)32415-X 19027621 · DOI
- [8]Sankaranarayanan R Rajkumar R Esmy PO Fayette JM Shanthakumary S Frappart L Thara S Cherian J Effectiveness, safety and acceptability of ‘see and treat’ with cryotherapy by nurses in a cervical screening study in India Br J Cancer 2007 96 5 738 743 10.1038/sj.bjc.6603633 17311015 PMC2360066 · DOI
- [11]Rosser JI, Hamisi S, Njoroge B, Huchko MJ. Barriers to cervical cancer screening in rural Kenya: perspectives from a provider survey. J Community Health. 2015; PMC8162879 25677728
- [12]Huchko M Maloba M Increasing access to cervical cancer screening: mobile screening on Mfangano Island, suba, Kenya Cervical cancer screening and prevention quarterly report 2013 Kisumu Kenya Medical Research Institute
- [13]Chamie G Kwarisiima D Clark TD Kabami J Jain V Geng E Petersen ML Thirumurthy H Kamya MR Havlir DV Leveraging rapid community-based HIV testing campaigns for non-communicable diseases in rural Uganda PLoS One 2012 7 8 e43400 10.1371/journal.pone.0043400 22916256 PMC3423366 · DOI
- [14]Lassi ZS Haider BA Bhutta ZA Community-based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes Cochrane Database Syst Rev 2010 11 CD007754 21069697
- [15]Granich R Kahn JG Bennett R Holmes CB Garg N Serenata C Sabin ML Makhlouf-Obermeyer C De Filippo Mack C Williams P Expanding ART for treatment and prevention of HIV in South Africa: estimated cost and cost-effectiveness 2011-2050 PLoS One 2012 7 2 e30216 10.1371/journal.pone.0030216 22348000 PMC3278413 · DOI
- [16]Glasgow RE Vogt TM Boles SM Evaluating the public health impact of health promotion interventions: the RE-AIM framework Am J Public Health 1999 89 9 1322 1327 10.2105/AJPH.89.9.1322 10474547 PMC1508772 · DOI · Paper page
- [18]Sudenga SL Rositch AF Otieno WA Smith JS Knowledge, attitudes, practices, and perceived risk of cervical cancer among Kenyan women: brief report Int J Gynecol Cancer 2013 23 5 895 899 10.1097/IGC.0b013e31828e425c 23694983 PMC3662490 · DOI
- [19]Denny L Kuhn L De Souza M Pollack AE Dupree W Wright TC Jr Screen-and-treat approaches for cervical cancer prevention in low-resource settings: a randomized controlled trial JAMA, J. Am. Med. Assoc. 2005 294 17 2173 2181 10.1001/jama.294.17.2173 16264158 · DOI · Paper page
- [20]Denny L Kuhn L CC H Tsai WY Wright TC Jr Human papillomavirus-based cervical cancer prevention: long-term results of a randomized screening trial J Natl Cancer Inst 2010 102 20 1557 1567 10.1093/jnci/djq342 20884893 · DOI · Paper page
- [21]Stewart DE Gagliardi A Johnston M Howlett R Barata P Lewis N Oliver T Mai V Self-collected samples for testing of oncogenic human papillomavirus: a systematic review J Obstet Gynaecol Can 2007 29 10 817 828 10.1016/S1701-2163(16)32636-6 17915065 · DOI
- [22]Zhao FH Lewkowitz AK Chen F Lin MJ SY H Zhang X Pan QJ Ma JF Niyazi M Li CQ Pooled analysis of a self-sampling HPV DNA test as a cervical cancer primary screening method J Natl Cancer Inst 2012 104 3 178 188 10.1093/jnci/djr532 22271765 PMC3274511 · DOI
- [23]Petignat P Faltin DL Bruchim I Tramer MR Franco EL Coutlee F Are self-collected samples comparable to physician-collected cervical specimens for human papillomavirus DNA testing? A systematic review and meta-analysis Gynecol Oncol 2007 105 2 530 535 10.1016/j.ygyno.2007.01.023 17335880 · DOI · Paper page
- [24]Trope LA Chumworathayi B Blumenthal PD Feasibility of community-based careHPV for cervical cancer prevention in rural Thailand J Low Genit Tract Dis 2013 17 3 315 319 10.1097/LGT.0b013e31826b7b70 23422644 · DOI
- [25]Ortiz AP Alejandro N Perez CM Otero Y Soto-Salgado M Palefsky JM Tortolero-Luna G Romaguera J Acceptability of cervical and anal HPV self-sampling in a sample of Hispanic women in Puerto Rico P R Health Sci J 2012 31 4 205 212 23844468 PMC3954748
- [26]Igidbashian S Boveri S Spolti N Radice D Sandri MT Sideri M Self-collected human papillomavirus testing acceptability: comparison of two self-sampling modalities J Women's Health (Larchmt) 2011 20 3 397 402 10.1089/jwh.2010.2189 21351869 · DOI
- [27]Ogilvie GS Mitchell S Sekikubo M Biryabarema C Byamugisha J Jeronimo J Miller D Steinberg M Money DM Results of a community-based cervical cancer screening pilot project using human papillomavirus self-sampling in Kampala, Uganda Int. J. Gynaecol. Obstet.:J. Int. Fed. Gynaecol. Obstet. 2013 122 2 118 123 10.1016/j.ijgo.2013.03.019 23731506 · DOI · Paper page
- [28]Rositch AF Gatuguta A Choi RY Guthrie BL Mackelprang RD Bosire R Manyara L Kiarie JN Smith JS Farquhar C Knowledge and acceptability of pap smears, self-sampling and HPV vaccination among adult women in Kenya PLoS One 2012 7 7 e40766 10.1371/journal.pone.0040766 22808257 PMC3393696 · DOI
- [29]Darlin L Borgfeldt C Forslund O Henic E Hortlund M Dillner J Kannisto P Comparison of use of vaginal HPV self-sampling and offering flexible appointments as strategies to reach long-term non-attending women in organized cervical screening J Clin Virology 2013 58 1 155 60 10.1016/j.jcv.2013.06.029 23867008 · DOI
- [30]Sancho-Garnier H Tamalet C Halfon P Leandri FX Retraite LL Djoufelkit K Heid P Davies P Piana L HPV self-sampling or the Pap-smear: A randomized study among cervical screening nonattenders from lower socioeconomic groups in France Int J Cancer 2013 133 11 2681 7 23712523
- [31]Leniz J Barriga MI Lagos M Ibanez C Puschel K Ferreccio C HPV vaginal self-sampling among women non-adherent to Papanicolaou screening in Chile Salud Publica Mex 2013 55 2 162 169 10.1590/S0036-36342013000200007 23546407 · DOI
- [32]Levinson KL Abuelo C Salmeron J Chyung E Zou J Belinson SE Wang G Ortiz CS Vallejos CS Belinson JL The Peru cervical cancer prevention study (PERCAPS): the technology to make screening accessible Gynecol Oncol 2013 129 2 318 323 10.1016/j.ygyno.2013.01.026 23385153 PMC3632388 · DOI
- [33]Snijders PJ Verhoef VM Arbyn M Ogilvie G Minozzi S Banzi R van Kemenade FJ Heideman DA Meijer CJ High-risk HPV testing on self-sampled versus clinician-collected specimens: a review on the clinical accuracy and impact on population attendance in cervical cancer screening Int. J. Cancer J Int cancer 2013 132 10 2223 2236 10.1002/ijc.27790 22907569 · DOI · Paper page
- [34]Virtanen A Nieminen P Luostarinen T Anttila A Self-sample HPV tests as an intervention for nonattendees of cervical cancer screening in Finland: a randomized trial Cancer Epidemiol. Biomark. Prev.: Publ. Am. Assoc. Cancer Res, Am. Soc. Prev. Oncol 2011 20 9 1960 1969 10.1158/1055-9965.EPI-11-0307 21752985 · DOI
- [35]Odeny TA Bailey RC Bukusi EA Simoni JM Tapia KA Yuhas K Holmes KK McClelland RS Text messaging to improve attendance at post-operative clinic visits after adult male circumcision for HIV prevention: a randomized controlled trial PLoS One 2012 7 9 e43832 10.1371/journal.pone.0043832 22957034 PMC3434192 · DOI · Paper page
- [36]Odeny TA Bailey RC Bukusi EA Simoni JM Tapia KA Yuhas K Holmes KK McClelland RS Effect of text messaging to deter early resumption of sexual activity after male circumcision for HIV prevention: a randomized controlled trial J Acquir Immune Defic Syndr 2014 65 2 e50 e57 10.1097/QAI.0b013e3182a0a050 23846561 PMC3867588 · DOI
- [37]Wesolowski A Eagle N Noor AM Snow RW Buckee CO Heterogeneous mobile phone ownership and usage patterns in Kenya PLoS One 2012 7 4 e35319 10.1371/journal.pone.0035319 22558140 PMC3338828 · DOI
- [38]Santesso N Schunemann H Blumenthal P De Vuyst H Gage J Garcia F Jeronimo J Lu R Luciani S Quek SC World Health Organization guidelines: use of cryotherapy for cervical intraepithelial neoplasia Int. J. Gynaecol. Obstet. 2012 118 2 97 102 10.1016/j.ijgo.2012.01.029 22727415 · DOI
- [39]Sauvaget C Muwonge R Sankaranarayanan R Meta-analysis of the effectiveness of cryotherapy in the treatment of cervical intraepithelial neoplasia Int J Gynaecol Obstet 2013 120 3 218 23 10.1016/j.ijgo.2012.10.014 23265830 · DOI
- [40]World Health Organization Organization WH WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention 2013 Geneva World Health Organization 24716265
- [41]Chamie G Clark TD Kabami J Kadede K Ssemmondo E Steinfeld R Lavoy G Kwarisiima D Sang N Jain V A hybrid mobile approach for population-wide HIV testing in rural east Africa: an observational study Lancet HIV 2016 3 3 e111 e119 10.1016/S2352-3018(15)00251-9 26939734 PMC4780220 · DOI
- [43]Rosser JI Njoroge B Huchko MJ Changing knowledge, attitudes, and behaviors regarding cervical cancer screening: The effects of an educational intervention in rural Kenya Patient Educ Couns 2015 98 7 884 9 10.1016/j.pec.2015.03.017 25858634 PMC4437717 · DOI · Paper page
- [47]Kotwani P Balzer L Kwarisiima D Clark TD Kabami J Byonanebye D Bainomujuni B Black D Chamie G Jain V Evaluating linkage to care for hypertension after community-based screening in rural Uganda Tropical Med Int Health 2014 19 4 459 468 10.1111/tmi.12273 PMC4118739 24495307 · DOI
- [48]Wang Z Norris SL Bero L Implementation plans included in World Health Organisation guidelines Implement Sci 2016 11 1 76 10.1186/s13012-016-0440-4 27207104 PMC4875699 · DOI
Cited by
Sorted by citations
Oketch, S. Y., Kwena, Z., Choi, Y., Adewumi, K., Moghadassi, M., Bukusi, E. A., & Huchko, M. J. (2019) · BMC Women's Health · doi:10.1186/s12905-019-0778-2 · Cited by 77 · see citing works
“The parent study enrolled women aged 25 to 65 years living within selected communities within Migori County, and offered HPV-based selfscreening in health facilities or through community health campaigns between January to September 2016 [23].”
BackgroundSelf-citationOommen, A. M., Ashfaq, M., Tonsing, M. V., Cherian, A. G., Singarayar, P., Viswanathan, V., Muniswamy, V., Hawkes, D., Abraham, P., Pricilla, R. A., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2025-101599 · Cited by 1 · see citing works
- Authors
- Huchko, M. J., Kahn, J. G., Smith, J. S., Hiatt, R. A., Cohen, C. R., & Bukusi, E.
- Affiliations
- Duke University (US)
- University of California, San Francisco (US)
- University of North Carolina at Chapel Hill (US)
- University of Nairobi (KE)
- Corresponding author
- Huchko, Megan J.
- ORCID
- Venue
- BMC Cancer
- Published
- 2017-12
- Volume
- 17
- Issue
- 1
- Pages
- 826-826
- ISSN
- 1471-2407 (ISSN-L)
- PMC
- PMC5717798
- OpenAlex
- W2772873441
- Cited by
- 18
- References
- 1
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 3 · 2019: 5 · 2018: 3
- FWCI
- 2.36
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Cancer (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Cancer Institute (R01-CA188428)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Keywords
- cervical cancer screening, HPV testing, community health campaign, linkage to treatment, self-collected samples, implementation strategies, RE-AIM framework, rural women, resource-limited settings, Western Kenya, cost-effectiveness
- MeSH terms
- Uterine Cervical Neoplasms, DNA, Viral, Female, Humans, Kenya, Risk Factors, Vaginal Smears, Cluster Analysis, Randomized Controlled Trials as Topic, Molecular Diagnostic Techniques, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review