Brief Title
The HPV Self-test as a Test of Cure in Madagascar
Official Title
The HPV Self-test as a Test of Cure in the Follow-up of HPV-positive Women in Madagascar
Brief Summary
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.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Cervical intra-epithelial neoplasia grade 2 or worse
Condition
Human Papilloma Virus Infection
Intervention
HPV test
Study Arms / Comparison Groups
HPV self-test
Description: Women will perform the HPV self-test.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
117
Start Date
June 2016
Completion Date
September 2016
Primary Completion Date
September 2016
Eligibility Criteria
Inclusion Criteria:
- women previously positive at HPV testing
Exclusion Criteria:
- pregnancy
Gender
Female
Ages
30 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Madagascar
Location Countries
Madagascar
Administrative Informations
NCT ID
NCT02811367
Organization ID
2016-00030
Responsible Party
Principal Investigator
Study Sponsor
University Hospital, Geneva
Study Sponsor
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Verification Date
October 2016