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.
Completed
- Conditions
- Herpes Genitalis
- Interventions
- Procedure: Blood samplingProcedure: Anogenital lesion swab collection
- Registration Number
- NCT04950712
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 537
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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Overall Study Group Anogenital lesion swab collection 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. Overall Study Group Blood sampling 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.
- Primary Outcome Measures
Name Time Method Number of patients with Polymerase Chain Reaction (PCR)-confirmed genital HSV-2 recurrences During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24) Genital HSV-2 recurrence is defined as presence of lesions in anogenital area (swelling, blisters, sores, crusts) and, a positive HSV-2 PCR test.
Duration of PCR-confirmed genital HSV-2 recurrences During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24) 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).
- Secondary Outcome Measures
Name Time Method 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) 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) 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 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) 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) Number of patients reporting genital HSV-2 recurrences by using eDiary Throughout the study period (from Day 1 up to 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 HSV-2 PCR self-swab results At first genital HSV-2 recurrence, 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) 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 recurrence during the 3 monthly calls with the investigator Throughout the study period (from Day 1 up to Month 24)
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Southampton, United Kingdom