Study Summary
This trial will test the effect of an mHealth solution, vDOT, on improving patient outcomes in TB/HIV patients in South Africa.
Eligible Conditions
- Adherence, Patient
- Tuberculosis (TB)
- Acquired Immunodeficiency Syndrome
- Care Coordination
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 2 Secondary · Reporting Duration: Up to 12 months
Up to 12 months
Number of deaths among participants
Number of participants lost to follow-up
Number of participants with treatment failure
Number of participants with treatment success
Up to 30 days
Time to linkage to care
Time to treatment initiation
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard of Care
1 of 2
mHealth intervention
1 of 2
Active Control
200 Total Participants · 2 Treatment Groups
Primary Treatment: mHealth intervention · No Placebo Group · N/A
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:
mHealth intervention
Other
ActiveComparator Group · 1 Intervention: CHW mHealth patient intervention for trigger escalation · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
Who is running the clinical trial?
University of Witwatersrand, South AfricaOTHER
88 Previous Clinical Trials
9,919,105 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,058 Previous Clinical Trials
31,003,777 Total Patients Enrolled
4 Trials studying Adherence, Patient
438 Patients Enrolled for Adherence, Patient
Jason E Farley, PhD, MPHPrincipal InvestigatorJohns Hopkins University School of Nursing
1 Previous Clinical Trials
68 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:About The Reviewer
Michael Gill - B. Sc.
First Published: October 25th, 2021
Last Reviewed: November 25th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
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