This is a before-and after study to evaluate the impact and feasibility of upscaling CC screening and treatment services for WLWH attending a rural referral CTC in Tanzania. The main objective is to evaluate the uptake by WLWH attending screening after implementation of HPV testing on a self-sampled cervico-vaginal smear, compared to a retrospective cohort screened by VIA. HPV testing has been implemented in a bundle with: a) a smartphone integrating a mobile colposcope (EVA system, Mobile ODT, Israel) for digital enhancement of VIA examination with cervix magnification and second look/quality control; b) thermal ablation in place of cryotherapy (thus avoiding the need for replenishing nitrogen gas cartridges); and c) LEEP.
We adopted an uncontrolled before-and-after design to compare proportion of WLWH attending screening before and after implementing mentioned interventions. A sub-study with cross-sectional design aims to explore diagnostic performance of two novel tests: the first, QuantiGene-Molecular-Profiling-Histology (QG-MPH), is based on transcriptomic biomarker analysis, while the second is a serological assay to detect antibodies against HPV16-L1 [29 (link)], either with a qualitative (Prevo-Check®) or quantitative (PT Monitor®) approach (Table1 . Supplementary material Annex A1 and A2). Further objectives are to determine the adherence to recommendations after screening, to assess the prevalence of HPV genotype-specific infection as well as other co-infections, and to assess feasibility, acceptability and costs of the new implemented screening and treatment plan.
We adopted an uncontrolled before-and-after design to compare proportion of WLWH attending screening before and after implementing mentioned interventions. A sub-study with cross-sectional design aims to explore diagnostic performance of two novel tests: the first, QuantiGene-Molecular-Profiling-Histology (QG-MPH), is based on transcriptomic biomarker analysis, while the second is a serological assay to detect antibodies against HPV16-L1 [29 (link)], either with a qualitative (Prevo-Check®) or quantitative (PT Monitor®) approach (Table
Novel assays
| Test | Name | Target | Description |
|---|---|---|---|
| Lateral Flow Assay (LFA) | PT Monitor® (Abviris GmbH, Germany) | HPV16-L1 Ab | Blood-based (serum) competitive immunoassay assessing the presence of epitope-specific antibodies against HPV16-L1. Elevated levels of these antibodies are associated with the presence of HPV16-induced cancer or pre-cancer. A quantitative readout is possible with an optical table-top reader (aLF reader by Qiagen, Germany). CE-marked IVD |
| Rapid Lateral Flow Assay (rLFA) | Prevo-Check® (Abviris GmbH, Germany) | HPV16-L1 Ab | Qualitative (yes/no) output of LFA (PT Monitor®) in form of rapid capillary point-of-care test with a cut-off of HPV16-L1 Ab > 1000 ng/ml. CE-IVD-marked for the detection of HPV16-induced anal and oropharyngeal cancers |
| Probe-based RNA Assay | HPV and dysplasia test – QuantiGene-Molecular-Profiling-Histology (QG-MPH) | mRNA of HPV oncogenes and cellular biomarkers | Cell-based. Quantitative detection of HPV16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82 and cellular biomarkers, correlating with severity of a dysplastic lesion. The emergence and strength of biomarkers define the lesion stage. The QuantiGene 2.0 platform (ThermoFisher) is used 2 Experimental molecular IVD, Charité-University Hospital Berlin, DE (WO2020/161285 A1) |
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