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

Human Papilloma Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811367
• Other study ID #: 2016-00030
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: October 14, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• women previously positive at HPV testing

Exclusion Criteria:

• pregnancy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia Grade 2/3
• Human Papilloma Virus Infection
• Papilloma
• Papillomavirus Infections
• Uterine Cervical Dysplasia
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Madagascar	Saint Damien Medical Center	Ambanja

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Madagascar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical intra-epithelial neoplasia grade 2 or worse		4 months	No