Digital Health Intervention to Improve TPT Uptake (DHiTPT)

Arba Minch University

Status: Not yet enrolling

Conditions: Tuberculosis, Pulmonary

Treatments: Behavioral: Digital health intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07313995

IRB/23333/2025

Details and patient eligibility

About

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.

Enrollment: 304 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All household and close contacts of drug-sensitive pulmonary TB patients
• Living in the catchment area of the selected health facility
• Willing to stay for at least 4 months in the catchment area

Exclusion criteria

• Individuals with a known allergy to TPT drugs or those contraindicated for TPT drugs
• Close contacts screened as symptomatic for TB
• Close contacts with drug-resistant TB
• Temporary residents staying for less than 4 months

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 2 patient groups

Digital health intervention

Experimental group

Description:

In this arm, the participants will receive standard care and a digital health intervention that includes video-based health education and text reminders.

Treatment:

Behavioral: Digital health intervention

Control

No Intervention group

Description:

In this arm, the participants will receive standard care based on the national guidelines.