What is the mechanism of action of this treatment?

Common treatments for HIV/AIDS, primarily antiretroviral therapy (ART), work by targeting various stages of the HIV life cycle to prevent the virus from replicating. This includes drugs like nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These treatments are essential for reducing the viral load, maintaining immune function, and improving the quality of life for patients. mHealth solutions, such as smartphone and tablet-based applications, support these treatments by enhancing adherence through reminders, educational content, and real-time support from community health workers, ultimately leading to better patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS, such as antiretroviral therapy (ART) regimens including drugs like stavudine, lamivudine, and nevirapine, are associated with several side effects. These can include gastrointestinal issues (nausea, diarrhea), metabolic complications (lipodystrophy, insulin resistance), and liver toxicity. Other side effects may involve skin rashes, fatigue, and potential drug-drug interactions. It's important for patients to discuss these potential side effects with their healthcare providers to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several antiretroviral therapies for the treatment of HIV/AIDS, including combination drugs that simplify treatment regimens. Notable approvals include single-tablet regimens like darunavir, cobicistat, emtricitabine, and tenofovir alafenamide, which are effective for both treatment-naïve and experienced patients. These combinations are particularly relevant to mHealth solutions that support CHWs in TB/HIV care, as they facilitate adherence and management of treatment in low-resource settings. Additionally, the use of electronic adherence monitoring, as studied in Botswana, highlights the importance of integrating technology to improve patient outcomes.

What other types of research exist?

Promising alternatives to mHealth solutions for supporting CHWs in TB/HIV care include: 1) Telemedicine platforms that offer remote consultations and monitoring, which can be particularly useful in areas with limited healthcare access. 2) Remote patient monitoring systems using non-invasive digital technologies to track patient health metrics and provide timely interventions. 3) Community-based interventions such as peer support groups and home visits by trained healthcare workers to ensure adherence and provide emotional support. 4) Integration of behavioral economics strategies to incentivize adherence and healthy behaviors among patients. These alternatives can complement existing mHealth solutions and provide a multifaceted approach to improving TB/HIV care.

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mHealth Intervention for TB/HIV Patient Outcomes (LEAP-TB-SA Trial)

N/A

Waitlist Available

Led By Jason E Farley, PhD, MPH

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any person 18 years of age or older with pulmonary TB

Outpatient TB treatment (including short course RR-TB treatment) or admission < 30 days is expected

Must not have

Extrapulmonary or disseminated TB disease

Severe clinical presentation: BMI < 18 kg/m2 or a person unable to stand/walk

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on mHealth interventions rather than medications, traditional side effects are not applicable. However, participants may experience issues related to technology use such as privacy concerns or stress from frequent monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and have pulmonary TB.

Select...

I am on or expect to start outpatient TB treatment soon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My TB has spread beyond my lungs.

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My BMI is under 18, or I cannot stand or walk.

Select...

I am willing and able to give informed consent in one of the approved languages.

Select...

I need to be hospitalized to start my TB treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of deaths among participants

Number of participants lost to follow-up

Number of participants with treatment failure

+1 more

Secondary study objectives

Time to linkage to care

Time to treatment initiation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: mHealth interventionActive Control1 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 CareActive Control1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV/AIDS, primarily antiretroviral therapy (ART), work by targeting various stages of the HIV life cycle to prevent the virus from replicating. This includes drugs like nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These treatments are essential for reducing the viral load, maintaining immune function, and improving the quality of life for patients. mHealth solutions, such as smartphone and tablet-based applications, support these treatments by enhancing adherence through reminders, educational content, and real-time support from community health workers, ultimately leading to better patient outcomes.

IAS Towards an HIV Cure Symposium: people focused, science driven: 18-19 July 2015, Vancouver, Canada.Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials.[Guidelines for caring for HIV-infected adults and postexposure prophylaxis for HIV infection].