NCT07703696Not yet recruiting
Effectiveness of Psychosocial Counseling in Patients With a New Tuberculosis Diagnosis
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
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
Introduction: Newly diagnosed TB patients frequently experience psychological distress, stigma, and concerns regarding treatment duration, side effects, and social consequences, which may negatively affect adherence. Psychosocial counseling has been proposed as a patient-centered 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 counseling intervention in improving treatment adherence and psychosocial outcomes among newly diagnosed TB patients receiving care in primary health care centers. Methods and Analysis: This study will employ a two-arm quasi-experimental design conducted in 10 primary health care centers (PHCs) in Semarang City, Indonesia. Five PHCs will be allocated to the intervention group and five PHCs to the control group to minimize contamination. A total of 108 newly diagnosed pulmonary TB patients will be recruited. Participants in the intervention group will receive a structured psychosocial counseling program in addition to standard TB care, while participants in the control group will receive standard TB care alone. Data will be collected at baseline (T0), immediately after the intervention (T1), and two 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 analyzed using descriptive statistics, mixed-design analysis of variance, chi-square tests, and multivariable logistic regression.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 7 Jul 2026
- Start date
- 19 Aug 2026
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Universitas Diponegoro
- Diseases
- Tuberculosis
- NCT number
- NCT07703696
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 19 Aug 2026 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- diagnosed with multidrug-resistant tuberculosis (MDR-TB), have severe cognitive impairment or psychiatric disorders that may affect their ability to participate in counseling sessions and study assessments, or have serious medical conditions requiring hospitalization at the time of recruitment.
Who the study is looking for
- be adults aged 18 years and older with a newly confirmed diagnosis of pulmonary tuberculosis who are scheduled to initiate anti-tuberculosis treatment at the participating PHCs
Age in the registry: 17 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PHC of Kedungmundu, Ngaliyan, Mijen, Gunungpati, Gayamsari, Tlogosari Kulon Coordinator of this site? Confirm its status | Semarang | Indonesia | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.