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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02811367
Enrollment
117
Registered
2016-06-23
Start date
2016-06-30
Completion date
2016-09-30
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEHPV test

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

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* women previously positive at HPV testing

Exclusion criteria

* pregnancy

Design outcomes

Primary

MeasureTime frame
Cervical intra-epithelial neoplasia grade 2 or worse4 months

Countries

Madagascar

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026