Background: Infection with the Herpes Simplex Virus is common but is not well understood and stigmatised. Whilst a considerable number of people experience mild to severe physical symptoms after infection, only one sub-effective drug is available for treatment. A registry collecting real world data reported by people with the Herpes Simplex Virus could help them manage their condition, facilitate research into a vaccine, better treatment, and the impact of herpes on other conditions.

Objective: This paper reports on the development a registry to collect real world data reported by people with the Herpes Simplex Virus.

Methods: A case study design was selected to support a systematic means of observing the subject of investigation. The case study followed seven stages: plan, design, prepare, collect, analyse, create and share. We carried out semi-structured interviews with experts, thematically analysed the findings and built use cases. These will be used to generate detailed models of how a real world evidence registry might look, feel, and operate for different users.

Results: We found the following key themes in the interviews: 1) stigma and anonymity; 2) selection bias; 3) understanding treatment and outcome gaps; 4) lifestyle factors; 5) individualised vs population-level; and 6) severe complications of herpes simplex virus. We developed use cases for different types of patients, members of the public, researchers and clinicians for a herpes simplex virus registry.

Conclusions: This case study showed insights for the development of an appropriate registry to collect real world data reported by people with the Herpes Simplex Virus. Further research is needed on developing and testing the registry with different users and evaluate its feasibility and effectiveness of collecting data to support symptom management, and the development of vaccines and better treatment.