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

NCT ID: NCT02811367

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-09-30

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.

Conditions

Human Papilloma Virus Infection; Cervical Intraepithelial Neoplasia Grade 2/3

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

HPV self-test

Women will perform the HPV self-test.

Group Type: EXPERIMENTAL

HPV test

Intervention Type: DEVICE

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

Interventions

HPV test

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• women previously positive at HPV testing

Exclusion Criteria

• pregnancy

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Prof. Patrick Petignat

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint Damien Medical Center

Ambanja, Madagascar, Madagascar

Countries

Madagascar

Other Identifiers

2016-00030

Identifier Type: -

Identifier Source: org_study_id