Effectiveness of Psychosocial Counseling on Treatment Adherence Among Patients With a New Tuberculosis Diagnosis in Primary Care: A Study Protocol of a Quasi-experimental Trial

Introduction Tuberculosis (TB) continues as a major global threat to public health. In 2024, TB is estimated to have infected more than 10 million people in 2024, and 1.23 million died. Indonesia accounts for 10% of the cases, becoming the second-highest country with a TB burden after India (25%)[1]. Despite ongoing efforts to strengthen TB control, treatment adherence remains a major challenge in Indonesia. Poor adherence to anti-tuberculosis treatment contributes to treatment failure, disease recurrence, and the emergence of drug-resistant tuberculosis. Indonesia remains among the countries with the highest burden of multidrug-resistant tuberculosis (MDR-TB), with 7.3% accounted for global cases in 2024 [1]. Although 73% of patients initiated treatment, only 55% completed the treatment course, indicating substantial gaps in treatment retention and continuity of care [2].

The challenges of TB treatment extend beyond clinical and pharmacological factors. Patients newly diagnosed with TB frequently experience psychological distress, including fear, anxiety, stigma, social isolation, and concerns about treatment duration and side effects [3-5]. Studies found that psychological distress affects nearly half of TB patients, with a pooled prevalence of 47.5% reported [6]. Anxiety is also common, affecting approximately 32.5% of patients, while depression has been reported in about 45.2% of individuals undergoing TB treatment [7,8]. Furthermore, TB-related stigma remains a significant psychosocial burden, contributing to social withdrawal, delayed health-seeking behavior, and poor treatment adherence.

The standard treatment regimen that requires at least six months of continuous medication demands substantial behavioral commitment and social support. These psychosocial burdens may negatively affect patients' motivation, self-efficacy, and treatment adherence, which compromises treatment outcomes. Previous studies have demonstrated that psychosocial factors substantially influence TB treatment outcomes. Depression has been associated with an increased risk of negative treatment outcomes, including loss to follow-up and mortality. A systematic review reported that patients with depressive symptoms had 8.7 times fold higher odds of loss to follow-up during treatment [9]. In addition, perceived stigma and inadequate social support have been consistently identified as barriers to treatment adherence and retention in care [10,11]. Therefore, addressing psychosocial factors is an essential component of comprehensive TB care.

Psychosocial counseling has been recognized as a promising strategy to support individuals coping with chronic illnesses by enhancing emotional well-being, strengthening coping mechanisms, and promoting health-related behaviors [12,13]. In the context of tuberculosis, counseling interventions may help patients understand their disease, manage treatment-related concerns, reduce stigma, and build confidence to complete treatment [14]. Despite growing recognition of the importance of patient-centered care, evidence regarding the effectiveness of psychosocial counseling for newly diagnosed TB patients in primary care settings remains limited, particularly in low- and middle-income countries such as Indonesia. Evaluating such interventions is therefore important for informing evidence-based strategies to improve treatment adherence and patient outcomes. This study aims to evaluate the effectiveness of a psychosocial counseling intervention among newly diagnosed tuberculosis patients receiving treatment in primary care compared with standard care. The intervention is guided by the Health Belief Model (HBM) and Social Cognitive Theory (SCT), which suggest that treatment adherence is influenced by patients' perceptions of disease severity and susceptibility, perceived benefits and barriers to treatment, self-efficacy, and social support. These theoretical constructs are incorporated into the counseling sessions to enhance patients' understanding of tuberculosis, strengthen coping strategies, reduce stigma-related concerns, and improve confidence in completing treatment.

Methods Study design and setting This study will employ a two-arm quasi-experimental design to evaluate the effectiveness of a psychosocial counseling intervention among newly diagnosed TB patients receiving treatment in primary care settings [15]. The study will be conducted over 2 months in 10 primary health care centers (PHCs) in Semarang City, Central Java, Indonesia. The participating PHCs will be selected based on having the highest TB case notifications in the city.