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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Herpes Genitalis

Intervention / Treatment
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* Procedure: Blood sampling
* Procedure: Anogenital lesion swab collection


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall Study Group<br>Patients aged 18 years old or above, with HSV-2 genital herpes, who are recruited in specific community settings in the United States and in Europe. | Procedure: Blood sampling<br>* Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).<br>Procedure: Anogenital lesion swab collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Polymerase Chain Reaction (PCR)-confirmed genital HSV-2 recurrences | Genital HSV-2 recurrence is defined as presence of lesions in anogenital area (swelling, blisters, sores, crusts) and, a positive HSV-2 PCR test. | During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24) | 
| Duration of PCR-confirmed genital HSV-2 recurrences | Duration of a recurrence is defined as number of consecutive days with the presence of HSV-2 lesion(s) and associated prodromal symptoms and/or erythema (skin redness). | During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of severity (PGI-S) questionnaire |  | From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months) | 
| Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of change (PGI-C) questionnaire |  | From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months) | 
| Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes symptoms checklist (HSC) questionnaire |  | From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months) | 
| Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes outbreak impact (HOIQ) questionnaire |  | From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months) | 
| Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HSC questionnaire |  | From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months) | 
| Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HOIQ questionnaire |  | From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months) | 
| 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 |  | At Enrolment Visit (Day 1) and at Day 1 of each PCR-confirmed recurrence | 
| 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 |  | At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24 | 
| Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by short form-12 questionnaire |  | At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24 | 
| Number of self-swabs collected during genital HSV-2 recurrences throughout the study period |  | Throughout the study period (from Day 1 up to Month 24) | 
| HSV-2 PCR self-swab results |  | At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months) | 
| HSV-2 PCR investigator swab results |  | At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months) | 
| Number of patients reporting genital HSV-2 recurrences by using eDiary |  | Throughout the study period (from Day 1 up to Month 24) | 
| Number of patients reporting genital HSV-2 recurrence during the 3 monthly calls with the investigator |  | Throughout the study period (from Day 1 up to Month 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes Simplex Virus-2, HSV-2 genital herpes, HSV-2 recurrence