The HPV Self-test as a Test of Cure in Madagascar
Primary Purpose
Human Papilloma Virus Infection, Cervical Intraepithelial Neoplasia Grade 2/3
Status
Completed
Phase
Not Applicable
Locations
Madagascar
Study Type
Interventional
Intervention
HPV test
Sponsored by
About this trial
This is an interventional diagnostic trial for Human Papilloma Virus Infection
Eligibility Criteria
Inclusion Criteria:
- women previously positive at HPV testing
Exclusion Criteria:
- pregnancy
Sites / Locations
- Saint Damien Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HPV self-test
Arm Description
Women will perform the HPV self-test.
Outcomes
Primary Outcome Measures
Cervical intra-epithelial neoplasia grade 2 or worse
Secondary Outcome Measures
Full Information
NCT ID
NCT02811367
First Posted
June 20, 2016
Last Updated
October 14, 2016
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT02811367
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus Infection, Cervical Intraepithelial Neoplasia Grade 2/3
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV self-test
Arm Type
Experimental
Arm Description
Women will perform the HPV self-test.
Intervention Type
Device
Intervention Name(s)
HPV test
Intervention Description
Women will perform the HPV self-test and will also undergo a physician-performed HPV test.
Primary Outcome Measure Information:
Title
Cervical intra-epithelial neoplasia grade 2 or worse
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women previously positive at HPV testing
Exclusion Criteria:
pregnancy
Facility Information:
Facility Name
Saint Damien Medical Center
City
Ambanja
Country
Madagascar
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The HPV Self-test as a Test of Cure in Madagascar
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