- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07609264
TB Stigma in the UK: Patients Experiences and Everyday Responses (TB stigma)
Making Sense of Tuberculosis (TB) Related Stigma in a Low-incidence Area of the UK: Patients Experiences and Everyday Responses
Public understanding of tuberculosis (TB) is shaped by sociocultural norms, educational background, and personal experiences. Misconceptions about TB transmission, disease severity, and treatment side effects are widespread, contributing to stigma and fear of social rejection. Such stigma can lead individuals to conceal their diagnosis, limiting access to support, engagement with healthcare, and overall health literacy.
TB-related stigma is recognised as a significant barrier to ending the global TB epidemic, affecting quality of life and access to care. Yet in high-income, low-incidence (HILI) countries like the UK, its prevalence, influence, and lived impact remain largely unexplored. Where stigma appears in research, it is often treated as an emerging theme, leaving a critical gap in understanding how individuals with TB, or those caring or supporting them, experience and respond to it.
This study adopts a Constructivist Grounded Theory (CGT) approach to examine TB-related stigma in depth. CGT allows the research to explore how people living with TB make sense of, interpret, negotiate, and resist stigma, capturing the dynamic and contextual ways it shapes their lives, identities, and interactions with healthcare systems. By investigating these meaning-making processes, the study aims to illuminate how stigma operates in the UK, providing insights to inform future stigma-reduction interventions, communication strategies, and supportive healthcare practices, ultimately benefiting patients, communities, and the NHS.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This study involves qualitative interviews with NHS patients diagnosed with tuberculosis (TB) exploring experiences of TB-related stigma using a constructivist grounded theory approach. The main ethical issues relate to participant vulnerability, informed consent within an emergent qualitative design, confidentiality, power imbalance, and data protection.
TB is a stigmatised condition, and discussing experiences of stigma may cause emotional distress. This has been addressed through the use of sensitive interviewing practices - commonly used by the researcher in their professional role as a TB Consultant Nurse, clear participant control over the interview process, and the right to pause, decline questions, or withdraw at any time. Interviews will be paused if participants show signs of emotional distress.
Participants will be given time to recover and asked whether they wish to proceed with the interview or stop.
Participants will be provided with information on relevant NHS and support services should participation raise concerns or distress.
Because constructivist grounded theory involves iterative (cyclical or repeated) analysis and co-construction of meaning, informed consent is treated as an ongoing process. Participants receive clear explanations of the study aims and methods in accessible language, and consent is revisited verbally at the start of each interview. Participation is voluntary, and withdrawal is possible without consequence to clinical care.
There is a risk of perceived coercion due to recruitment within NHS services and the patient-researcher power imbalance. This is mitigated by separating research from clinical care, using non-clinical recruitment where possible (including advertising through networks), and explicitly stating that participation or non-participation will not affect treatment.
Confidentiality and anonymity are key considerations due to the small number of TB patients within individual NHS Trusts and the risk of deductive disclosure. All data will be anonymised, identifying details removed or altered, and findings reported in a way that minimises identification. Data will be stored securely in accordance with UK GDPR and NHS data governance requirements.
The study also raises ethical considerations regarding representation and interpretation of participant accounts. Reflexive practices are used to address researcher positionality and power in co-constructing data, and findings will be disseminated responsibly to avoid reinforcing stigma. Overall, the study has been designed to minimise risk, protect participant dignity and autonomy, and comply with NHS ethical, legal, and governance requirements.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: David Thomas, MRes, BSc, RN
- Número de teléfono: 0300 019 4570
- Correo electrónico: david.thomas117@nhs.net
Ubicaciones de estudio
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Dorset
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Bournemouth, Dorset, Reino Unido
- University Hospitals Dorset
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Contacto:
- David Thomas, MRes, BSc, RN
- Número de teléfono: 0300 019 4570
- Correo electrónico: david.thomas117@nhs.net
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Investigador principal:
- David Thomas, MRes, BSc, RN
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
This study seeks participants who have been diagnosed with pulmonary TB, extrapulmonary TB, latent TB infection (LTBI), and drug sensitive or drug resistant TB within the last 10 years. Participants may have different cultural and socioeconomic backgrounds and will be resident within a pre-defined TB low-incidence coastal/rural area of the UK.
Inclusion criteria
- Aged 18 or over at start of study
- Resident in rural or coastal areas within South or Southwest England
- Diagnosed with either active or latent TB within the last 10 years
Exclusion criteria
- Lacks mental capacity or is unwilling to consent to participate in the study
- Under 18 years of age
- Lives in an area of TB high-incidence (above 10 cases/100,000 population) or outside of rural and coastal areas of South/Southwest England
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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People diagnosed with active or latent TB in the last 10 years
Aged over 18. Living in coastal or rural areas of South, Southwest England (TB low incidence areas).
Able to understand, converse and consent to participation using the English language.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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TB stigma in the UK: Patients experiences and everyday responses
Periodo de tiempo: From enrolment to completion of interviews is likely to be up to 3 months for individual participants. Recruitment runs for 10 months.
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The aim of this study is to understand how individuals diagnosed with tuberculosis in a rural and coastal area of Southwest England experience, interpret, and respond to TB related stigma, and to develop a Constructivist Grounded Theory that accounts for the social processes shaping its production and negotiation.
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From enrolment to completion of interviews is likely to be up to 3 months for individual participants. Recruitment runs for 10 months.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Spruijt I, Haile DT, van den Hof S, Fiekert K, Jansen N, Jerene D, Klinkenberg E, Leimane I, Suurmond J. Knowledge, attitudes, beliefs, and stigma related to latent tuberculosis infection: a qualitative study among Eritreans in the Netherlands. BMC Public Health. 2020 Oct 23;20(1):1602. doi: 10.1186/s12889-020-09697-z.
- Bedingfield N, Lashewicz B, Fisher D, King-Shier K. Systems of support for foreign-born TB patients and their family members. Public Health Action. 2022 Jun 21;12(2):79-84. doi: 10.5588/pha.21.0081.
- Braga S, Vieira M, Barbosa P, Ramos JP, Duarte R. Tuberculosis screening in the European migrant population: a scoping review of current practices. Breathe (Sheff). 2024 Mar;20(1):230357. doi: 10.1183/20734735.0357-2023. Epub 2024 May 14.
- Craig GM, Daftary A, Engel N, O'Driscoll S, Ioannaki A. Tuberculosis stigma as a social determinant of health: a systematic mapping review of research in low incidence countries. Int J Infect Dis. 2017 Mar;56:90-100. doi: 10.1016/j.ijid.2016.10.011. Epub 2016 Oct 27.
- 41. Charmaz K. Constructing grounded theory. 2nd ed. London: Sage; 2014
- Thomas D, Summers RH. Patients' perceptions and experiences of directly observed therapy for TB. Br J Nurs. 2022 Jul 7;31(13):680-689. doi: 10.12968/bjon.2022.31.13.680.
- Goffman E. Stigma: notes on the management of spoiled identity. New York: Simon & Schuster; 1963
- World Health Organization. The End TB Strategy. Geneva: WHO; 2014. Available from: https://www.who.int/publications/i/item/WHO-HTM-TB-2015.19
- Stop TB Partnership. The global plan to end TB 2023-2030. Geneva: Stop TB Partnership; 2022
- Seyedmehdi SM, Jamaati H, Varahram M, Tabarsi P, Marjani M, Moniri A, Alizadeh N, Hassani S. Barriers and facilitators of tuberculosis treatment among immigrants: an integrative review. BMC Public Health. 2024 Dec 18;24(1):3514. doi: 10.1186/s12889-024-21020-8.
- Ahmed R, Zumla A, Taylor E, Aklillu E, Ippolito G, Satta G. Perspectives on tuberculosis in migrants, refugees, and displaced populations in Europe. IJID Reg. 2025 Mar 19;14(Suppl 2):100576. doi: 10.1016/j.ijregi.2025.100576. eCollection 2025 Mar.
- European Centre for Disease Prevention and Control, WHO Regional Office for Europe. Tuberculosis surveillance and monitoring in Europe 2025 - 2023 data. Stockholm: ECDC/WHO Regional Office for Europe; 2025
- UK Health Security Agency. Tuberculosis in England, 2025 report (data up to end of 2024). London: National TB Unit; 2025.
- World Health Organization. Global tuberculosis report 2024. Geneva: WHO; 2024.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11172 (REB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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