| Randomized controlled trials |
|---|
| Polman et al. 2019,15 the Netherlands | RCT, non-inferiority, part of a regular screening program, IMPROVE (full terms not specified) study Dutch Trial register (NTR5078) | 13,925 women analyzed 7,643 women were included in the self-sampling group and 6,282 in the clinician-based sampling group Aged 29 to 61 years | Self-sampling group: women requested to collect their own cervicovaginal sample using an Evalyn Brush (Rovers Medical Devices BV, Oss, Netherlands) versus Clinician-based sampling group: samples collected by a general practitioner with a Cervex-Brush (Rovers Medical Devices BV) HPV tests: validated GP5+/6+ PCR enzyme immunoassay (Labo Biomedical Products BV, Rijswijk, Netherlands). | Primary endpoints Detection of cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) Diagnostic test accuracy (sensitivity and specificity) Non-inferiority of HPV testing on self-collected versus clinician-collected samples: evaluated against a margin of 90% for the relative sensitivity and 98% for the relative specificity Median follow-up duration for HPV-positive women: 20 months |
| Ajenifuja et al. 2018,16 Nigeria | RCT, two-arm, multiple visits, single centre | 194 women presenting for cervical cancer screening underwent both self- and provider sampling for HPV DNA testing using Hybribio GenoArray. | self- versus provider sampling Group A: provider sampling before self sampling Group B: self sampling before undergoing provider sampling HPV tests: HPV DNA testing using Hybribio GenoArray | Degree of agreement between self and provider sampling for HPV DNA tests Follow-up time: not reported |
| Non-randomized studies |
|---|
| Thay et al. 2019,17 Cambodia | Cohort, prospective | 250 Cambodian women between 30 and 49 years of age 129 HIV-positive and 121 HIV-negative Recruited from the National Center for HIV/AIDS Dermatology and sexually transmitted disease cohort, the Sihanouk Hospital Center of Hope’s Rural Outreach Teams and the Pochentong Medical Center. | (1) self-sampled human papilloma virus (HPV) testing (careHPV system) versus (2) clinician-collected HPV testing versus (3) visualization with acetic acid versus (4) digital colposcopy with the Enhanced Visual Assessment System HPV tests: careHPV system for 14 genotypes of hrHPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) | HPV prevalence and cervical intraepithelial neoplasia (CIN) status Agreement of self- and clinician-sampled HPV tests HPV infection detected with self- or clinician-collected samples Follow-up duration: not reported |
| Toliman et al. 2019,22 Papua New Guinea and Australia | Cross-sectional | 1,005 women attending for cervical cancer screening at 2 clinics Aged 30 to 59 years | Self-collected vaginal specimens versus Clinician-collected cervical specimens HPV tests: Cepheid Xpert HPV, Roche Cobas 4800 HPV and Hologic Aptima HPV assays | Agreement in HPV detection Sensitivity and specificity of self-sampled HPV tests for the detection of HPV infection identified with clinician-collected samples High-grade squamous intraepithelial lesions (HSIL) detection for cytology Follow-up not mentioned |
| Des Marais et al. 2018,18 US | Observational, 2nd phase of My Body, My Test observational study | 193 women overdue for cervical cancer screening by national guidelines Low-income, infrequently screened women Inclusion criteria: 30–64 years of age; no history of Pap testing in the past 4 years (overdue for screening by national guidelines at the start of the study); household income below 250% of the poverty level; not pregnant; not had a hysterectomy; and uninsured, underinsured, or had Medicaid insurance. | 1) a cervicovaginal sample self-collected by brush at home and returned by mail (self-home sample), 2) a cervicovaginal sample self-collected by brush in a clinic and handed to a nurse (self-clinic sample), versus 3) a cervical sample collected by brush by a clinician during a pelvic examination (clinician sample) HPV tests: Aptima HPV assay (E6/E7 mRNA of 14 high-risk HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) | High risk HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium infection Agreement between diagnostic test accuracy Follow-up time not reported |
| Lam et al. 2018,5 Denmark | Cohort, including part of the Copenhagen Self-sampling Initiative (CSi) implementation Study and Horizon study | 4865 non-attenders who participated in self-sampling and 4291 women attending routine screening Analyzed with 3347 samples collected in the Horizon study (cytology and HPV tests with physician-collected samples) Non-attendees: women who had not been screened for at least 4 (if aged 27–49 years) or 6 years (if aged 50–65 years). | Self-sampling in non-attenders versus Routine screening in women attending routine screening (cytology or contesting with HPV and cytology) CSi: opt-in pilot project, self sampling, HPV+ followed up by HPV and cytology contesting, some screened by general practitioner-collected cytology CSi non-responders: possibly symptom-based diagnosis Horizon study: routine screening, physician-collected cytology, additionally tested for HPV HPV tests: HC2, cobas, CLART, and APTIMA | Cervical intraepithelial neoplasia grade 2 or worse (≥CIN2) detection rate Positive predictive values for the detection of CIN2+ HPV positivity defined by CLART (Genomica, Madrid, Spain) and Onclarity (BD, Sparks, MD, USA) assays Follow-up: 18 months in the CSi study |
| Phoolcharoen et al. 2018,23 Thailand | Cross-sectional, in a colposcopy clinic | 247 pairs of samples Inclusion criteria: attending the colposcopy clinic, aged 30–70 years, no history of cervical cancer, no hysterectomy, and currently not pregnant. | Self-sampling with a dry brush versus Physician-collected endocervical samples from the same individuals HPV tests: Cobas4800 HPV test (Roche Molecular Diagnostics, Pleasanton, California, USA) | Concordance between vaginal self- and endocervical physician-collected high-risk HPV testing Follow-up not reported |
| Senkomago et al. 2018,19 US | Cohort, prospective | 350 female sex workers Aged 18 to 50 years | Self-collected cervico-vaginal specimens for hrHPV RNA testing versus Physician collected cervical specimens for hrHPV-RNA testing and conventional cytology hrHPV-RNA testing every 3 months Conventional cytology every 6 months HPV tests: Aptima (qualitatively detecting E6/E7 mRNA of 14 hrHPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) | HPV prevalence Agreement between physician- and self-collected hrHPV-RNA results Diagnostic test accuracy of HPV tests for the detection of high-grade squamous intraepithelial cervical lesions or worse Follow-up between December 2, 2009, and February 15, 2013 |
| Wong et al. 2018,8 China | Cohort | 68 female sex workers Inclusion criteria: aged 18 years or older, not currently pregnant, no known abnormal Papanicolaou test results and no symptoms of cervical cancer, genital cancer, cervical surgery, or immune treatment of the cervix during the 6 months before recruitment into the study | Self-sampling for HPV testing versus Clinician-obtained sample for HPV testing HPV DNA testing in the university laboratory | Agreement in HPV detection rates between clinician and HPV DNA self-sampling Agreement definition: k < 0: poor k = 0 to 0.20: slight k = 0.21 to 0.40: fair k = 0.41 to 0.60: moderate k = 0.61 to 0.80: substantial k = 0.81 to 1.00: perfect Follow-up lengths not reported |
| Zhang et al. 2018,9 China | Cohort, prospective, the Shanxi Province Cervical Cancer Screening Study I (SPOCCS I) | 1,997 women Inclusion criteria: aged 35 to 45 with no history of cervical cancer or hysterectomy in 1999 | HPV testing on self-collected and physician-collected samples, cytology and visual inspection with acetic acid (VIA) HPV tests: HC2 assays (Hybrid Capture II, Qiagen Inc.) | Cumulative diagnostic test accuracy for the detection of CIN2+ at 6-year, 11-year and 15-year follow-up Follow-up in 1999 (baseline), 2005, 2010 and 2014 |
| Cremer et al. 2017,20 US and El Salvador | Cohort, phase 2 of Cervical Cancer Prevention in El Salvador, 3 phases in total | N = 8050 in phase 2, aged 30 to 49 years | self- and provider-collected specimens HPV tests not reported | Agreement of diagnostic test accuracy Follow-up: 6 months after screening |
| Obiri-Yeboah et al. 2017,21 Ghana | Cohort, comparative frequency-matched study (1:5), part of a larger HPV and cervical cancer study conducted in the Cape Coast Teaching Hospital (CCTH) | 194 women attending HIV and outpatient clinics in the Cape Coast Teaching Hospital, Ghana Mean age 44.1 years (SD ± 11.3) 191 paired results | Self-collection of vaginal samples using the careHPV brush versus Clinician-collected cervical sample HPV DNA (14 high-risk types) tests: careHPV assay (Qiagen) and HPV genotyping (Anyplex II, Seegene) | HPV detection concordance Follow-up available if cytology required |
