Tuberculosis, Pulmonary
Conditions
Keywords
Digital Health, TB preventive therapy, TPT initiation
Brief summary
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.
Interventions
BEHAVIORALDigital health intervention
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.
Sponsors
Arba Minch University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Treatment: digital health intervention Control: standard care
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TB preventive therapy initiation | It will be up to 3 months. | 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) |
| TB preventive therapy completion | It will be up to 4 months. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contact investigations | 12 weeks. | 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) |
| TB prevalence | within 4 months | Assess TB prevalence among household/close contacts during the study period. |
Countries
Ethiopia
Contacts
CONTACTGistane Ayele
Outcome results
None listed