Academic Journal

Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial

التفاصيل البيبلوغرافية
العنوان: Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial
المؤلفون: Pretsch P.K, Spees L.P, Brewer N.T, Hudgens M.G, Sanusi B, Rohner E, Miller E, Jackson S.L, Barclay L, Carter A, Wheeler S.B, Smith J.S
المصدر: The Lancet Public Health, 8(6)
بيانات النشر: Elsevier Ltd
سنة النشر: 2023
المجموعة: Carolina Digital Repository (UNC - University of North Carolina)
مصطلحات موضوعية: Humans, current smoker, male, Wart virus, medicaid, household income, employment, uterine cervix tumor, female, unemployment, Uterine Cervical Neoplasms, questionnaire, United States, clinical trial, single (marital status), major clinical study, intention to treat analysis, divorced person, married person, aged, phase 3 clinical trial, sensitivity analysis, papillomavirus infection, injury, controlled study, logistic regression analysis, demographics, medicare, outcome assessment, human
الوصف: Background: Most cervical cancer in the USA occurs in under-screened women. The My Body, My Test-3 (MBMT-3) trial sought to assess the efficacy of mailed human papillomavirus (HPV) self-collection kits with appointment-scheduling assistance to increase uptake of cervical cancer screening among under-screened women from low-income backgrounds compared with scheduling assistance alone. Methods: MBMT-3 is a phase 3, open-label, two-arm, randomised controlled trial. Participants were recruited from 22 counties in North Carolina state, USA, and we partnered with 21 clinics across these counties. Participants were eligible for inclusion if they were aged 25–64 years, had an intact cervix, were uninsured or enrolled in Medicaid or Medicare, had an income of 250% or less of the US Federal Poverty Level, were living within the catchment area of a trial-associated clinic, and were overdue for screening (ie, Papanicolaou test ≥4 years ago or high-risk HPV test ≥6 years ago). Participants were randomly assigned (2:1) to receive a mailed HPV self-collection kit and assistance for scheduling a free screening appointment (intervention group) or to receive scheduling assistance alone (control group). Randomisation was conducted by county using permuted blocks of nine patients and assignment to group was not masked. Participants in the intervention group were mailed HPV self-collection kits to collect a cervical-vaginal sample and return it by mail for testing. Samples were tested with the Aptima HPV assay (Hologic, San Diego, CA, USA), and participants were informed of high-risk HPV results by telephone call. Trial staff made up to three telephone call attempts to provide scheduling assistance for in-clinic screening for all participants. The primary outcome was cervical cancer screening uptake (ie, attending an in-clinic screening appointment or testing negative for high-risk HPV with a returned self-collected sample) within 6 months of enrolment in the intention-to-treat population. This trial is registered with ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
Relation: https://doi.org/10.17615/htyc-qw26; https://cdr.lib.unc.edu/downloads/dz011170j?file=thumbnail; https://cdr.lib.unc.edu/downloads/dz011170j
DOI: 10.17615/htyc-qw26
الاتاحة: https://doi.org/10.17615/htyc-qw26
https://cdr.lib.unc.edu/downloads/dz011170j?file=thumbnail
https://cdr.lib.unc.edu/downloads/dz011170j
رقم الانضمام: edsbas.AD85AB37
قاعدة البيانات: BASE