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 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.12345

Why 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?

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

No Study Results Posted | Leveraging mHealth to Enable and ...An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...
Leveraging mHealth to Enable and Adapt CHW Strategies ...Leveraging mHealth to Enable and Adapt Community Health Worker Strategies to Improve TB/HIV Patient Outcomes in South Africa (LEAP-TB-SA) Trial.
Leveraging mHealth to Enable and Adapt CHW Strategies ...This study combines these individual cascade step approaches into an innovative TB/HIV cascade intervention study entitled, "Leveraging mHealth to enable and ...
mHealth Intervention for TB/HIV Patient Outcomes · Info ...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.
Community health worker-based mobile health (mHealth ...Primary outcomes were: (a) the proportion of patients adhering to complete AL course and, (b) the proportion of patients' returning to the facility on day 3.
A Remote Intervention Based on mHealth and Community ...The remote CHAMPS pilot study demonstrated the feasibility and acceptability of combining mHealth tools with CHW support to promote medication adherence among ...
NIH Public AccessQualitative analyses found improvements in patient care and logistics and broad support for the mHealth intervention among patients, clinic staff, and PHWs. Key ...
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