Tuberculosis Clinical Trial
Official title:
The Usability Testing of the IeHS (Integrated E-healthcare Services) Web-based Application in the Therapy Management of HIV and Tuberculosis in Indonesia: a Concurrent Nested Study Design
Technology that has a particular focus on patients' needs and ease-of-use and -access plays a significant role in the development of e-health and m-health. The proposed model of a secured mobile health application may promote patient's self-management and enhances adherence in chronic therapy exactly as it is easy-to-use, reducing patient's burden in accessing medication information and instructions, and providing the opportunity for direct communications with health providers in charge for each patient with access to mobile technologies. Consequently, medication errors and unnecessary paperwork in the healthcare system will be avoided as well as giving more time for healthcare providers to pay greater attention to delivering medical care effectively and efficiently.
Tuberculosis (TB) remains the world's leading infectious threat as it kills more than 1
million people worldwide every year, with most of them in low and middle-income countries1.
Several medical conditions impair innate and acquired immunity and favor the occurrence of TB
disease in individuals who are latently infected2,3. People living with HIV (PLHIV) have a
higher risk to be infected by TB as their immunocompromised status than that of HIV negative
and as the cause of death in a quarter of PLHIV/AIDS4,5. Malnutrition and protein imbalance,
i.e., in diabetes, can also impair the immune system and increase the risk of TB and
TB-related death2,6. The daunting rise in cases of TB, HIV, and diabetes poses further major
threats to public health worldwide. They were ranked as top diseases to cause high mortality
in South East Asia (SEA), which accounted for deaths for 1.6 million, 940,000, and 30.3
million in 2017, respectively. The association between communicable and non-communicable
diseases has been known for the past years, yet the optimization of the therapy remains
scarce. Therefore, sustained and well-maintained healthcare approaches to make sure patients
stay adherent and compliant to medication therapy are needed and remain of utmost importance.
Beyond the deadly combinations of the diseases and the improvement in disease treatments, an
issue on the communication among the involved parties (e.g., physicians, pharmacists, and
patients) needs to be marked crucial. Physicians and pharmacists have each specific role in
the healthcare system, and the positive impacts of their collaboration have been established
in several studies. The collaborative relationship between physicians and pharmacists
accelerates the improvement of patient's therapy and thus provides a better quality of care.
However, barriers in communications can still be noticed in the healthcare setting,
especially in countries where the existence of pharmacists is limited. Time constraints and
ineffective communication would be the significant points needing to be considered. This
situation should be avoided as poor communication among them may lead to several negative
impacts such as prescribing errors, treatment delay, unidentified adverse events, and even
death7,8.
Over the last decades, mobile phone technology as a part of information and communication
technology (ICT) has considerably been used in supporting diseases' treatments as a modality
to improve medical care efficiency and adherence and to provide continuously updated clinical
evidence. The ubiquity of mobile technologies, such as smartphones, enhances the ability to
assess and improve general health. It has therefore created salient opportunities for the
treatment and evaluation of a large number of common, intractable, expensive medical
conditions. Such technologies in the healthcare setting can easily be accessed and are likely
cost-effective, given its modest costs9. For example, a cost analysis of the use of mobile
phones in Kenya revealed that text-message intervention in HIV treatment was cost-effective
on the basic travel of expenses alone10. Conversely, concerns also have been expressed
regarding the safety, confidentiality, quality of its content, and regulations on the use of
mobile health applications11.
Much attention has been directed at the use of ICT in Indonesia due to the nations' unique
geographic and socioeconomic characteristics. Indonesia is an archipelago country with 270
million population (population density of 140.08 individuals per square kilometer of land
area)12. Being ranked 4th of countries with the highest population and the seventh largest
country in terms of combined sea and land area worldwide, Indonesia is then believed to be
one of the fastest growing markets for mobile phones in the SEA with 438.6 million mobile
users. Having to mentioned the explanations above, the investigators, therefore, will
research an easy-to-use - yet confidential and comprehensive - web-based healthcare
application to be applied to high-risk patients; i.e., TB and HIV. By applying this web-based
app to the specific population, the investigators hope to enhance the quality of care as well
as the quality of life of such patients. The investigators will report on the findings and
then discuss the future use of the web-based app.
With the complexity of drugs treatments in HIV and TB, treatment using mobile technologies is
increasingly valued and becoming a trend over the past years. Technology that has a
particular focus on patients' needs and ease-of-use and -access plays a significant role in
the development of e-health and m-health. The proposed model of a secured mobile health
application may promote patient's self-management and enhances adherence in chronic therapy
exactly as it is easy-to-use, reducing patient's burden in accessing medication information
and instructions, and providing the opportunity for direct communications with health
providers in charge for each patient with access to mobile technologies. Consequently,
medication errors and unnecessary paperwork in the healthcare system will be avoided as well
as giving more time for healthcare providers to pay greater attention to delivering medical
care effectively and efficiently.
The objective of the study is to conduct a usability testing of the web-based app in
high-risk participants (HIV and TB patients). Usability testing will be conducted using a
quantitative approach to evaluate the effectiveness, efficiency, and user satisfaction. After
performing the usability testing of the web-based app on selected participants, investigators
perform an in-depth interview to explore further problems, barriers, feedbacks, and potential
advantages of the use of IeHS web-based app.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |