mHealth Intervention for TB/HIV Patient Outcomes

(LEAP-TB-SA Trial)

Overseen By Jason E Farley, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Extrapulmonary TB, Severe presentation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

62 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 4 6 7 8}

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. ^{3 4 6 7 9}

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

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.

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?

Group I: mHealth intervention Active Control 1 Intervention

Individuals randomized to the intervention arm will receive the same standardized adherence education, followed by an orientation session to the study intervention. This orientation will include education on basic smartphone operations and use. The CHW will set up appointment reminders for clinic visits as well as daily adherence reminders for submission of the video DOT sessions and symptom reports. A smartphone capable of downloading apps, receiving short message service (SMS) and access wifi and cellular connectivity will be provided to intervention patients. All patients are seen face-to-face monthly for adherence monitoring, monthly symptom reports and laboratory evaluations per standard of care treatment guidelines. All research participants will also receive a clinic visit quality checklist to ensure completeness of standard of care procedures.

Group II: Standard of Care Active Control 1 Intervention

Individuals randomized to standard of care will receive a standardized adherence education session and provided with a paper-based diary to track appointments and adherence. Instructions will be provided on the importance of daily adherence in the primary health care facility closest to patients' residence, as per standard of care. Directly observed therapy (DOT) is recommended for all patients at patients' nearest clinic. All patients are seen face-to-face monthly for adherence monitoring, monthly symptom reports and laboratory evaluations per standard of care treatment guidelines. All research participants will also receive a clinic visit quality checklist to ensure completeness of standard of care procedures.

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

1. United States pubmed.ncbi.nlm.nih.gov

Using mHealth for HIV/TB Treatment Support in Lesotho: Enhancing Patient-Provider Communication in the START Study. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Effects of an mHealth Intervention for Pulmonary Tuberculosis Self-management Based on the Integrated Theory of Health Behavior Change: Randomized Controlled Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. Australia pubmed.ncbi.nlm.nih.gov

MHEALTH INTERVENTION DEVELOPMENT TO SUPPORT PATIENTS WITH ACTIVE TUBERCULOSIS. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

mHealth: An updated systematic review with a focus on HIV/AIDS and tuberculosis long term management using mobile phones. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of digital adherence technologies for drug-susceptible tuberculosis treatment supervision: A meta-analysis of implementation feedback. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Analysing mHealth usage logs in RCTs: Explaining participants' interactions with type 2 diabetes self-management tools. [2022]