COS for HTLV

• Research type

  Research Study

• Full title

  Developing a Core Outcome Set and Identifying outcome measurement instruments to measure COS for use in clinical practice and research in Human T-Cell Lymphotropic Virus Type-1

• IRAS ID

  356279

• Contact name

  Adine Adonis

• Contact email

  adine.adonis@postgrad.manchester.ac.uk

• Sponsor organisation

  University of Manchester

• Clinicaltrials.gov Identifier

  NHS002281, UoM Sponsor Reference

• Duration of Study in the UK

  1 years, 9 months, 8 days

• Research summary

  Human T-Cell Lymphotropic Virus-Type1 (HTLV-1) is a rare virus mainly affecting Afro-Caribbean and Black African communities, particularly women. The virus remains lifelong in the body, with patients either remaining asymptomatic (asymptomatic carriers/ACs) or developing HTLV-Associated-Myelopathy (HAM). HAM causes difficulty with walking, climbing stairs, and using bathrooms, sometimes requiring wheelchairs. Asymptomatic carriers live with anxiety about potential disease progression.

  Currently, no standardised means exist for measuring disease progression across treatment and research settings. Existing measures are medically dominated and don't reflect patient priorities. Patients report that current measurements, particularly blood virus levels, don't capture real-world disease impacts.

  This research aims to develop a comprehensive core outcome set through :

  Aim 1: Identify Key Outcomes
  - Review existing literature on HTLV-1 outcomes
  - Conduct interviews/focus groups with patients, caregivers, and clinicians
  - Survey participants to prioritise outcome importance
  - Hold online meetings to finalise essential outcomes

  Aim 2: Select Measurement Tools
  - Search for existing tools measuring identified outcomes
  - Assess tool quality and appropriateness
  - Conduct online consensus meetings to agree on final measurement instruments

  This study will last for upto 2 years.Participants will be involved in semi-structured interviews or focus groups, participate in a survey and group discussions to determine key outcomes and select measurement tools.

  Patient and Public Involvement
  People with HTLV-1 will actively shape this research topic. They will also actively shape this research process, helping develop interview questions, interpret data as management team members, and decide on final outcome measures. They will receive payment for their contributions.

  Dissemination
  Results will be shared through videos/infographics/social media/conferences, and open-access publications. Patients will co-present findings and help develop implementation guidelines.

  Following completion, additional funding will be sought to investigate disease evolution over time using this newly developed core outcome set, ultimately improving understanding and care for this underserved population.
  

• REC name

  Wales REC 4

• REC reference

  25/WA/0339

• Date of REC Opinion

  1 Dec 2025

• REC opinion

  Further Information Favourable Opinion