mHealth Intervention for TB/HIV Patient Outcomes
(LEAP-TB-SA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve care for patients with both tuberculosis (TB) and HIV using mobile health (mHealth) technology. Participants will use a smartphone to receive reminders for medication, clinic visits, and symptom reports, while community health workers manage their care through the CHW mHealth patient intervention for trigger escalation. The goal is to determine if this mHealth approach can better support treatment and improve patient outcomes compared to standard care. Individuals diagnosed with pulmonary TB (TB in the lungs), who are HIV positive, and are receiving outpatient TB treatment might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions that could enhance treatment for others in the future.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this mHealth intervention is safe for TB/HIV patients?
Research shows that using mobile health (mHealth) tools with community health workers (CHWs) is generally safe for people with TB and HIV. Studies indicate that people are comfortable with this approach. In past trials, patients found the technology and support from CHWs easy to use. No major negative effects have been directly linked to the mHealth tools.
The goal is to help patients follow their treatment plans using smartphones, which provide reminders and track symptoms. This method has improved patient care and received support from both patients and clinic staff. While this study phase does not offer detailed safety data, previous evidence suggests that this approach is safe and effective in helping patients take their medication as prescribed.12345Why are researchers excited about this trial?
Researchers are excited about the mHealth intervention for TB/HIV patient outcomes because it leverages technology to enhance patient adherence and engagement. Unlike the standard of care, which involves paper diaries and face-to-face reminders, this intervention uses smartphones to send appointment and daily adherence reminders, making it more accessible and personalized. This tech-savvy approach not only simplifies the tracking of medication and symptoms through video DOT sessions but also empowers patients with real-time connectivity and support, potentially improving health outcomes significantly.
What evidence suggests that this mHealth intervention is effective for improving TB/HIV patient outcomes?
This trial will compare the effectiveness of a mobile health (mHealth) intervention with standard care for patients with TB and HIV. Participants in the mHealth intervention arm will receive a smartphone with apps for appointment and medication reminders, along with support from community health workers (CHWs). Studies have shown that mHealth tools can significantly improve patient adherence to treatment plans. Research indicates that mobile phone apps and CHWs help patients take their medication on time and attend clinic visits regularly. Early findings suggest this approach helps identify treatment issues early, which is crucial for patient health. Additionally, evidence from similar programs shows that patients become more engaged in their care and achieve better health outcomes, especially in resource-limited areas.12367
Who Is on the Research Team?
Jason E Farley, PhD, MPH
Principal Investigator
Johns Hopkins University School of Nursing
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HIV who are outpatient TB patients or expected to be admitted for less than 30 days. They must be able to give informed consent in an approved language and have pulmonary TB, not requiring hospitalization at treatment start, without severe clinical issues like a BMI under 18 or inability to stand/walk.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mHealth intervention or standard of care for TB/HIV treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CHW mHealth patient intervention for trigger escalation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
University of Witwatersrand, South Africa
Collaborator