NCT04950712

An Epidemiological Study to Assess Performance of Using Healthcare Tools to Understand Genital Herpes Simplex Virus-2 (HSV-2) in Patients ≥ 18 Years of Age in the United States and Europe.

A Descriptive, Prospective, Multi-country, Multicentre Study to Assess Performance of Genital Herpes Simplex Virus-2 (HSV-2) Related Disease Endpoints Based on Patient-reported Health Outcomes, Self-swabbing Collected Via Decentralised Approach in Patients ≥ 18 Years of Age in the United States and Europe.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 537 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe. More specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well as the performance study procedures in a decentralised setting. Ultimately, this study will allow generating additional real-world evidence (RWE) on patterns of recurrences and other key parameters.

Conditions

• Herpes Genitalis

Interventions

Type	Name	Description
PROCEDURE	Blood sampling	Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).
PROCEDURE	Anogenital lesion swab collection	Anogenital lesion swab of all lesions are collected at screening visit (only for newly infected HSV-2 patients) and at first genital HSV-2 recurrence during the study period.

Timeline

• Start date: 2021-06-09
• Primary completion: 2024-03-14
• Completion: 2024-03-14
• First posted: 2021-07-06
• Last updated: 2025-03-07

Locations

51 sites across 6 countries: United States, Finland, France, Italy, Spain, United Kingdom