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Completed

NCT Number: NCT02811367

The HPV Self-test as a Test of Cure in Madagascar

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.

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women previously positive at HPV testing

Exclusion criteria

  • pregnancy

Treatment and study plan

HPV test

Device

Women will perform the HPV self-test and will also undergo a physician-performed HPV test.

Primary outcomes

  1. Cervical intra-epithelial neoplasia grade 2 or worse

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

The HPV Self-test as a Test of Cure in the Follow-up of HPV-positive Women in Madagascar

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2016
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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