Frontiers in tuberculosis · 2026
An integrated psycho-social intervention to improve self-efficacy toward TB treatment uptake and infection prevention among patients and family caregivers: a multicentric implementation research study protocol.
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Nagaraj Karikalan, Daniel Bella Devaleenal, Suresh Chandra, Angamuthu Dhanalakshmi, Palanisamy Shobana, Malaisamy Muniyandi
Аннотация
BACKGROUND: The individuals with tuberculosis (TB) experience a variety of barriers, needs, and challenges when receiving the treatment. Evidence on holistic patient-centered psychosocial interventions that promote self-efficacy and the ability to complete treatment-related tasks and goals is scarce in India.
OBJECTIVES: To adapt an intervention aimed at strengthening the self-efficacy of individuals on TB treatment and their family caregivers, and to evaluate its effectiveness compared with the standard of care on the primary outcome of improved TB treatment self-efficacy and secondary outcomes of improved medication adherence, reduced TB-related stigma, and improved infection control practices.
METHODS: A multicentric hybrid Type I mixed method implementation research design will be used to adapt and evaluate the implementation feasibility and effectiveness of delivering a self-efficacy-based intervention under National Tuberculosis Elimination Program (NTEP) settings in India. A two-arm non-randomized cluster intervention design will be employed to evaluate the impact of a self-efficacy intervention, which includes individual counseling and peer group sessions (n = 240) in comparison to the standard of care (n = 240) on primary and secondary outcomes. Qualitative in-depth interviews and focus group discussions, guided by the Consolidated Framework for Implementation Research (CFIR), will be conducted to explore contextual factors influencing implementation.
DISCUSSION: The proposed study could generate evidence for a holistic and evidence-informed psycho-social intervention for individuals with TB and their family caregivers. It aims to improve their self-efficacy in overcoming TB treatment challenges and address the key psycho-social barriers comprehensively. Qualitative insights from the study are expected to guide/facilitate the pragmatic scale-up of self-efficacy-based interventions under the National TB program of India.
CLINICAL TRIAL REGISTRATION: The study has been registered in the Clinical Trial Registry of India CTRI/2024/05/066847.
OBJECTIVES: To adapt an intervention aimed at strengthening the self-efficacy of individuals on TB treatment and their family caregivers, and to evaluate its effectiveness compared with the standard of care on the primary outcome of improved TB treatment self-efficacy and secondary outcomes of improved medication adherence, reduced TB-related stigma, and improved infection control practices.
METHODS: A multicentric hybrid Type I mixed method implementation research design will be used to adapt and evaluate the implementation feasibility and effectiveness of delivering a self-efficacy-based intervention under National Tuberculosis Elimination Program (NTEP) settings in India. A two-arm non-randomized cluster intervention design will be employed to evaluate the impact of a self-efficacy intervention, which includes individual counseling and peer group sessions (n = 240) in comparison to the standard of care (n = 240) on primary and secondary outcomes. Qualitative in-depth interviews and focus group discussions, guided by the Consolidated Framework for Implementation Research (CFIR), will be conducted to explore contextual factors influencing implementation.
DISCUSSION: The proposed study could generate evidence for a holistic and evidence-informed psycho-social intervention for individuals with TB and their family caregivers. It aims to improve their self-efficacy in overcoming TB treatment challenges and address the key psycho-social barriers comprehensively. Qualitative insights from the study are expected to guide/facilitate the pragmatic scale-up of self-efficacy-based interventions under the National TB program of India.
CLINICAL TRIAL REGISTRATION: The study has been registered in the Clinical Trial Registry of India CTRI/2024/05/066847.