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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
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Human Papilloma Virus Infection

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
June 20, 2016
Last Updated
October 14, 2016
Sponsor
University Hospital, Geneva
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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

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

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