62 Participants Needed

mHealth Intervention for TB/HIV Patient Outcomes

(LEAP-TB-SA Trial)

KL
JE
Overseen ByJason E Farley, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses mobile phone apps and community health workers to help people with HIV and rif-resistant TB in South Africa stick to their treatment plans. The apps remind patients to take their medicine and allow health workers to check in on them through video calls. This approach aims to improve health outcomes by ensuring patients follow their treatment plans and get timely support.

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.

Is the mHealth intervention for TB/HIV patients safe for humans?

The mHealth interventions, including mobile phone applications and SMS reminders, have been generally well-received and considered acceptable by patients and healthcare workers in various studies. No specific safety concerns for humans were reported in the research, but challenges like technical issues and financial constraints were noted.12345

How does the mHealth intervention for TB/HIV differ from other treatments?

The mHealth intervention for TB/HIV is unique because it uses mobile technology to enhance patient self-management and communication with healthcare providers, which can improve adherence to treatment and reduce drug resistance. Unlike traditional treatments, this approach involves real-time support through SMS messaging and trained health workers, making it more interactive and supportive for patients.34678

What data supports the effectiveness of the mHealth treatment for TB/HIV patient outcomes?

Research shows that mHealth interventions, like using mobile phones for reminders and support, can help patients stick to their treatment plans for conditions like TB and HIV. Studies have found that these interventions improve patient-provider communication and increase adherence to treatment guidelines, which can lead to better health outcomes.34679

Who Is on the Research Team?

JE

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

I am 18 or older and have pulmonary TB.
I am on or expect to start outpatient TB treatment soon.
HIV positive

Exclusion Criteria

My TB has spread beyond my lungs.
My BMI is under 18, or I cannot stand or walk.
I am willing and able to give informed consent in one of the approved languages.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mHealth intervention or standard of care for TB/HIV treatment

12 months
Monthly face-to-face visits for adherence monitoring and symptom reports

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CHW mHealth patient intervention for trigger escalation
Trial Overview The study tests a mobile health (mHealth) intervention by community health workers (CHWs) aimed at improving patient outcomes for those with TB/HIV in South Africa. It leverages smartphone and tablet apps designed to enhance screening, linkage to care, treatment initiation, and adherence.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: mHealth interventionActive Control1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

University of Witwatersrand, South Africa

Collaborator

Trials
107
Recruited
10,090,000+

Citations

Using mHealth for HIV/TB Treatment Support in Lesotho: Enhancing Patient-Provider Communication in the START Study. [2022]
Effects of an mHealth Intervention for Pulmonary Tuberculosis Self-management Based on the Integrated Theory of Health Behavior Change: Randomized Controlled Trial. [2022]
Effect of mobile-phone messaging on patient and health-worker knowledge and adherence to the isoniazid preventive therapy guideline in HIV clinics in Southeast, Nigeria. [2021]
MHEALTH INTERVENTION DEVELOPMENT TO SUPPORT PATIENTS WITH ACTIVE TUBERCULOSIS. [2020]
mHealth: An updated systematic review with a focus on HIV/AIDS and tuberculosis long term management using mobile phones. [2022]
A pilot study of an mHealth application for healthcare workers: poor uptake despite high reported acceptability at a rural South African community-based MDR-TB treatment program. [2022]
The feasibility, acceptability, and preliminary impact of real-time monitors and SMS on tuberculosis medication adherence in southwestern Uganda: Findings from a mixed methods pilot randomized controlled trial. [2023]
Acceptability and feasibility of digital adherence technologies for drug-susceptible tuberculosis treatment supervision: A meta-analysis of implementation feedback. [2023]
Analysing mHealth usage logs in RCTs: Explaining participants' interactions with type 2 diabetes self-management tools. [2022]
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