An observational study in Cervical Cancer Screening, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Tanzania. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by University Hospital, Basel, Switzerland · Observational
This study is to analyse the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO), comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022). It is to assess the performance of two novel diagnostic tests (QuantiGene-molecular profiling histology (QG-MPH) and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening.
Cervical cancer (CC) is the most common cancer among women living with HIV (WLWH) and the leading cause of cancer-related death in women in East Africa. Currently there are around 2800 WLWH in care at the Chronic Disease Clinic of Ifakara (CDCI), of whom only 8% attended CC screening services in the last three years.
This research project is to assess (with a mixed-method, before-/after-study) the impact of a bundle of procedures, which consists of: portable colposcopy, Human Papilloma Virus (HPV) testing and treatment of precancerous cervical lesions by Loop electrosurgical excision procedure (LEEP).
This study is also to analyze the prevalence of cervical disease in the cohort, stratified by stage and co-infections, as well as the acceptability, feasibility and costs.
Additionally, it will assess the performance of two novel diagnostic tests (QG-MPH and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening. This is an implementational study nested within the KIULARCO study consisting of two interacting parts: a pre/post assessment of the impact of the bundle of interventions with mixed-methods study design and the diagnostic tests accuracy (evaluated with a cross-sectional study). The treatment investigated is regarded as standard treatment.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 2,974 is above the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women will be informed during their routine control within HIV care about the study on improved CC screening procedures and referred to the study team if consenting.
All interventions will be offered routinely to patients, but are not mandatory if they refuse them. Patients not consenting will be advised to seek regular services for CC screening according to the national guidelines. Apart from routine clinical visits, no additional visits are scheduled for this study unless medically indicated.
Exclusion Criteria:
Data collection * on the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO) comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022) * on the performance of three novel tests as triage tool in the screening algorithm, QG-MPH, Prevo-check® and PT Monitor®
Number of WLWH attending CC screening
Number of WLWH attending CC screening in the period 08/2021 - 06/2022; Attendance of screening: for the pre-phase women undergoing Visual inspection with acetic acid (VIA), for the post- phase women performing cervical self-sampling.
Time frame: one time assessment at Screening
Number of detected High Grade Squamous Intraepithelial Lesion /Cervical Cancer (HSIL/CC) in cervical self-samples by QuantiGene-molecular profiling histology (QG-MPH)
Diagnostic test accuracy in detecting High Grade Squamous Intraepithelial Lesion /Cervical Cancer (HSIL/CC) in cervical self-samples by QuantiGene-molecular profiling histology (QG-MPH)
Time frame: one time assessment at Screening
Number of detected patients with Human Papilloma Virus (HPV) 16 and 18 induced Cervical Intraepithelial Neoplasia grade 3 or above (CIN3+) by Serum PT Monitor®.
Diagnostic test accuracy in detecting patients with Human Papilloma Virus (HPV) 16 and 18 induced Cervical Intraepithelial Neoplasia grade 3 or above (CIN3+) by Serum PT Monitor®.
Time frame: one time assessment at Screening
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland