Clinical trial 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Genitalis
Keywords: Herpes Simplex Virus-2
HSV-2 genital herpes
HSV-2 recurrence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited in specific community settings in the United States and in Europe. Screening logs will be used to assess participation rate.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Man or woman ≥18 years old.
* Written informed consent obtained from the patient prior to performance of any study-specific procedure.
* History of at least one episode of HSV-2 genital herpes lesions in the 12 months preceding the screening, and seropositive for HSV-2 as determined by Western blot OR PCR-positive for HSV-2 (newly diagnosed patients).
* Patients who are medically stable in the opinion of the investigator.
* Patients who, in the opinion of the investigator, are able to understand and comply with the study requirements (attend regular telephone calls/study site visits/home visits/self-completion of questionnaires, self-swabbing).
* Seronegative for HIV, as determined by laboratory testing. Patients documented to be positive to HIV will not be eligible for study participation

Exclusion Criteria:

* Prior receipt of a vaccine or candidate vaccine containing HSV antigens.
* Immunocompromised patients, as per medical history and investigator judgement.
* Other genital tract disorders or sexually transmitted diseases that may interfere with the assessment of the study (as per investigator's judgement).

Primary outcomes:
measure: Number of patients with Polymerase Chain Reaction (PCR)-confirmed genital HSV-2 recurrences
timeFrame: During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)
measure: Duration of PCR-confirmed genital HSV-2 recurrences
timeFrame: During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)
Secondary outcomes:
measure: Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of severity (PGI-S) questionnaire
timeFrame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
measure: Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of change (PGI-C) questionnaire
timeFrame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
measure: Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes symptoms checklist (HSC) questionnaire
timeFrame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
measure: Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes outbreak impact (HOIQ) questionnaire
timeFrame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
measure: Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HSC questionnaire
timeFrame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
measure: Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HOIQ questionnaire
timeFrame: From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
measure: Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by EuroQoL-5 dimension (EQ-5D) health questionnaire
timeFrame: At Enrolment Visit (Day 1) and at Day 1 of each PCR-confirmed recurrence
measure: Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by Recurrent genital herpes quality-of-life (RGHQoL) questionnaire
timeFrame: At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24
measure: Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by short form-12 questionnaire
timeFrame: At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24
measure: Number of self-swabs collected during genital HSV-2 recurrences throughout the study period
timeFrame: Throughout the study period (from Day 1 up to Month 24)
measure: HSV-2 PCR self-swab results
timeFrame: At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
measure: HSV-2 PCR investigator swab results
timeFrame: At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
measure: Number of patients reporting genital HSV-2 recurrences by using eDiary
timeFrame: Throughout the study period (from Day 1 up to Month 24)
measure: Number of patients reporting genital HSV-2 recurrence during the 3 monthly calls with the investigator
timeFrame: Throughout the study period (from Day 1 up to Month 24)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Smyrna
country: United States
facility: GSK Investigational Site
state: Georgia
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Lawrenceville
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Newark
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Montpellier cedex
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Paris cedex 14
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Pierre BEnite
country: France
facility: GSK Investigational Site
city: Saint-Etienne
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Bari
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Palermo
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Alcorcon
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Marbella
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Brighton
country: United Kingdom
facility: GSK Investigational Site
city: Leeds Yorkshire
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: