NCT02811367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

June 20, 2016

Last Update Submit

October 14, 2016

Conditions

Human Papilloma Virus InfectionCervical Intraepithelial Neoplasia Grade 2/3

Outcome Measures

Primary Outcomes (1)

  • Cervical intra-epithelial neoplasia grade 2 or worse

    4 months

Study Arms (1)

HPV self-test

EXPERIMENTAL

Women will perform the HPV self-test.

Device: HPV test

Interventions

HPV testDEVICE

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

HPV self-test

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women previously positive at HPV testing

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Damien Medical Center

Ambanja, Madagascar, Madagascar

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Human Papillomavirus DNA Tests

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Diagnostic TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 23, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

MA(1)