Patient Compliance to Self-collection for Detection of HPV-DNA
NCT ID: NCT02431520
Last Updated: 2015-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2007-05-31
2007-12-31
Brief Summary
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Detailed Description
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The compliance was measured by the delivery of the specimen obtained by self-collection or to attend to a visit at the community health center to be submitted to Pap smear collection, within a week.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Self-collection
Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for Hybrid Capture II (HCII).
Self-collection
Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for HCII.
Gynecologist collection
Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist
Gynecologist collection
Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist
Interventions
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Self-collection
Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for HCII.
Gynecologist collection
Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist
Eligibility Criteria
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Inclusion Criteria
* Not pregnant
* Had held their last Pap smear for over a year
* Could read.
Exclusion Criteria
* History of cervical cancer or its precursors
* Bearers of some state of chronic immunosuppression (such as HIV ou autoimmune diseases)
* Those who underwent self-collection of their specimen during menstrual period
25 Years
59 Years
FEMALE
No
Sponsors
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Oswaldo Cruz Foundation
OTHER
Responsible Party
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Principal Investigators
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Fabio B Russomano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IFF/Fiocruz
Locations
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Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira (IFF/Fiocruz)
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
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References
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Brink AA, Meijer CJ, Wiegerinck MA, Nieboer TE, Kruitwagen RF, van Kemenade F, Fransen Daalmeijer N, Hesselink AT, Berkhof J, Snijders PJ. High concordance of results of testing for human papillomavirus in cervicovaginal samples collected by two methods, with comparison of a novel self-sampling device to a conventional endocervical brush. J Clin Microbiol. 2006 Jul;44(7):2518-23. doi: 10.1128/JCM.02440-05.
Cuzick J. Human papillomavirus testing for primary cervical cancer screening. JAMA. 2000 Jan 5;283(1):108-9. doi: 10.1001/jama.283.1.108. No abstract available.
Dzuba IG, Diaz EY, Allen B, Leonard YF, Lazcano Ponce EC, Shah KV, Bishai D, Lorincz A, Ferris D, Turnbull B, Hernandez Avila M, Salmeron J. The acceptability of self-collected samples for HPV testing vs. the pap test as alternatives in cervical cancer screening. J Womens Health Gend Based Med. 2002 Apr;11(3):265-75. doi: 10.1089/152460902753668466.
Gontijo RC, Derchain SF, Montemor EB, Sarian LO, Serra MM, Zeferino LC, Syrjanen KJ. [Pap smear, hybrid capture II, and visual inspection in screening for uterine cervical lesions]. Cad Saude Publica. 2005 Jan-Feb;21(1):141-9. doi: 10.1590/s0102-311x2005000100016. Epub 2005 Jan 28. Portuguese.
Harper DM, Hildesheim A, Cobb JL, Greenberg M, Vaught J, Lorincz AT. Collection devices for human papillomavirus. J Fam Pract. 1999 Jul;48(7):531-5.
Wikstrom I, Stenvall H, Wilander E. Attitudes to self-sampling of vaginal smear for human papilloma virus analysis among women not attending organized cytological screening. Acta Obstet Gynecol Scand. 2007;86(6):720-5. doi: 10.1080/00016340701303747.
Wright TC Jr, Denny L, Kuhn L, Pollack A, Lorincz A. HPV DNA testing of self-collected vaginal samples compared with cytologic screening to detect cervical cancer. JAMA. 2000 Jan 5;283(1):81-6. doi: 10.1001/jama.283.1.81.
Mandelblatt JS, Lawrence WF, Womack SM, Jacobson D, Yi B, Hwang YT, Gold K, Barter J, Shah K. Benefits and costs of using HPV testing to screen for cervical cancer. JAMA. 2002 May 8;287(18):2372-81. doi: 10.1001/jama.287.18.2372.
Ogilvie G, Krajden M, Maginley J, Isaac-Renton J, Hislop G, Elwood-Martin R, Sherlock C, Taylor D, Rekart M. Feasibility of self-collection of specimens for human papillomavirus testing in hard-to-reach women. CMAJ. 2007 Aug 28;177(5):480-3. doi: 10.1503/cmaj.070013.
Other Identifiers
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58/07
Identifier Type: -
Identifier Source: org_study_id
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