BMJ open · 2026
Effectiveness of psychosocial counselling on treatment adherence among patients with a new tuberculosis diagnosis in primary care: a study protocol for a cluster-randomised controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Shaluhiyah Zahroh, Handayani Sri, Sriatmi Ayun, Agushybana Farid, Rimawati Eti
Аннотация
INTRODUCTION: Newly diagnosed tuberculosis (TB) patients frequently experience psychological distress, stigma, and concerns regarding treatment duration, side effects and social consequences, which may negatively affect adherence. Psychosocial counselling has been proposed as a patient-centred strategy to address these challenges; however, evidence regarding its effectiveness among newly diagnosed TB patients in primary care settings remains limited. This study aims to evaluate the effectiveness of a psychosocial counselling intervention in improving treatment adherence and psychosocial outcomes among newly diagnosed TB patients receiving care in primary healthcare centres (PHCs).
METHODS AND ANALYSIS: This study will employ a two-arm, parallel, cluster-randomised controlled trial involving 10 PHCs in Semarang City, Indonesia. PHCs will serve as clusters and will be randomly allocated in a 1:1 ratio to either the intervention or control arm (n=5 PHCs per arm) to minimise treatment contamination. An independent researcher will perform computer-generated randomisation. A total of 108 newly diagnosed pulmonary TB patients will be recruited. Participants in the intervention group will receive a structured psychosocial counselling programme in addition to standard TB care, while participants in the control group will receive standard TB care alone per national guidelines. Data will be collected at baseline (T0), immediately after the intervention (T1) and 2 months after treatment initiation (T2). The primary outcome is treatment adherence during the intensive phase of treatment. Secondary outcomes include psychological distress, TB-related stigma, TB knowledge and treatment self-efficacy. Data will be analysed using descriptive statistics, mixed-effects models and multilevel logistic regression analyses that account for clustering at the PHC level.
ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Committee of the Faculty of Public Health, Diponegoro University (304/EA/KEPK-FKM/2026). Written informed consent will be obtained from all participants prior to enrolment. Study findings will be disseminated through peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT07703696). Protocol V.2.0 (15 September 2026).
METHODS AND ANALYSIS: This study will employ a two-arm, parallel, cluster-randomised controlled trial involving 10 PHCs in Semarang City, Indonesia. PHCs will serve as clusters and will be randomly allocated in a 1:1 ratio to either the intervention or control arm (n=5 PHCs per arm) to minimise treatment contamination. An independent researcher will perform computer-generated randomisation. A total of 108 newly diagnosed pulmonary TB patients will be recruited. Participants in the intervention group will receive a structured psychosocial counselling programme in addition to standard TB care, while participants in the control group will receive standard TB care alone per national guidelines. Data will be collected at baseline (T0), immediately after the intervention (T1) and 2 months after treatment initiation (T2). The primary outcome is treatment adherence during the intensive phase of treatment. Secondary outcomes include psychological distress, TB-related stigma, TB knowledge and treatment self-efficacy. Data will be analysed using descriptive statistics, mixed-effects models and multilevel logistic regression analyses that account for clustering at the PHC level.
ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Committee of the Faculty of Public Health, Diponegoro University (304/EA/KEPK-FKM/2026). Written informed consent will be obtained from all participants prior to enrolment. Study findings will be disseminated through peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT07703696). Protocol V.2.0 (15 September 2026).