NCT02811367

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	HPV test	Women will perform the HPV self-test and will also undergo a physician-performed HPV test.

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-06-23
• Last updated: 2016-10-17

Locations

1 site across 1 country: Madagascar