An interventional study of Digital health intervention in Tuberculosis, Pulmonary, sponsored by Arba Minch University. Recruiting at 14 sites in Ethiopia. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Arba Minch University · Not applicable, Interventional, and Health services research
Despite the evidence of the prevention and control measures of tuberculosis (TB), it still has an impact on the health, social, and economic aspects of the population. Specifically, tuberculosis in children and newly diagnosed TB cases show there is current transmission of TB; to reduce this transmission and to attain the end TB strategy, preventing household TB transmission plays a great role. However, initiation and completion of TB preventive therapy (TPT) among close contacts of index TB patients are suboptimal. Some of the identified factors of low TPT initiation and completion are insufficient patient education, inadequate understanding of TPT, health professionals' perception, parental knowledge, and belief. The digital health intervention is currently being studied as a suggested health intervention that improves the utilization of health care services, including treatment adherence. A systematic review shows that TB treatment outcomes improved with the use of patient education, counseling, text reminders, and digital health technologies. However, other literature indicates controversial results, including our systematic review result, which identified that video directly observed therapy and text message (digital intervention) have no significant effect on TPT completion. In addition, the studies are scarce; therefore, this study aims to assess the effect of video-based education intervention combined with text message reminder (digital health intervention) in improving the initiation and completion of TPT among close contacts of drug-sensitive pulmonary TB patients in South Ethiopia.
The study hypothesizes that digital health intervention for close contacts of index drug-sensitive pulmonary TB patients will lead to higher TPT initiation and completion rates than standard care.
Exclusion Criteria:
In this arm, the participants will receive standard care and a digital health intervention, which is video-based health education through a mobile phone.
Behavioral: Digital health intervention
In this arm, the participants will receive standard of care based on the national TB and TB/HIV guidelines.
The treatment arm will provide a digital health intervention (video-based health education) in addition to standard care. Video-based education will be provided for 5-7 minutes every week for three weeks.
TB preventive therapy initiation
The primary outcome of this study will be the number of close contacts to index TB patients who initiated TPT (mean change of TPT initiation from the baseline)
Time frame: It will be up to 4 months.
TB preventive therapy completion
The second primary outcome of this study will be the number of close contacts to index TB patients who completed TPT (the mean change of TPT completion in relation to baseline data)
Time frame: It will be up to 4 months.
Contact investigations
Close contacts of index drug-sensitive pulmonary TB patients who were identified and screened for TB (the mean change of contact investigation in relation to baseline data)
Time frame: 16 weeks.
TB prevalence
Assess TB prevalence among household/close contacts during the study period.
Time frame: within 8 months
Plan to share: Undecided — It is not yet decided
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Arba Minch University