An interventional study of HPV test in Human Papilloma Virus Infection and Cervical Intraepithelial Neoplasia Grade 2/3, sponsored by University Hospital, Geneva. Completed at 1 site in Madagascar. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-17.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Diagnostic
The purpose of this study is to find out whether Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.
The efficacy and the availability of cold coagulation render it a valuable technique for the treatment of precancerous lesions in low-resource settings. The Human Papillomavirus (HPV) test performed by women themselves (HPV self-test) could be an efficient method to assess the long-term risk of recurrent/persistent disease in women with a history of HPV infection and cervical intra-epithelial lesions grade 2 or higher (CIN2+).
A total of 443 HPV-positive women, aged 30-65 years, have been selected through a screening campaign conducted in Ambanja, Madagascar, between 2013 and 2015. Of these, 260 have been treated by cold coagulation, conisation or electrocauterization. A follow-up visit at 1-3 years after primary screening will be organized for all HPV-positive women detected at primary screening. Participants will perform an HPV self-test. A sample for cytology and HPV testing will also be collected by the physician. The goal of the study will be the histological search for CIN2+ lesions at one to three years after primary screening.
The investigators expect to see that Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's enrollment of 117 is below the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Women will perform the HPV self-test.
Device: HPV test
Women will perform the HPV self-test and will also undergo a physician-performed HPV test.
Cervical intra-epithelial neoplasia grade 2 or worse
Time frame: 4 months
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Jun 2016, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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