Digital Health Intervention to Improve TPT Uptake

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorArba Minch University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Digital health intervention

    Behavioral

    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.

Treatment groups

304 Participants
are divided into 2 treatment groups
Group A: Digital health interventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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 3 months.
2

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.

Secondary outcomes

1

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
12 weeks.
2

TB prevalence

Assess TB prevalence among household/close contacts during the study period.

Time frame
within 4 months

Other outcomes

Sponsors and contacts

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