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

Q: How many individuals are being enrolled in this experiment?

<p>Affirmative. According to records on clinicaltrials.gov, this medical study is presently enrolling participants with the initial posting occurring on March 10th 2022 and a recent update also taking place then. The trial aims to include 200 patients from 1 site in total.</p>

Q: Are there any opportunities for enrolment in this trial right now?

<p>Per the information presented on clinicaltrials.gov, this investigation is open to volunteers. It was initially submitted to the platform on March 10th 2022 and has since been modified accordingly.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

LEAP-TB-SA Trial Summary

This trial will test the effect of an mHealth solution, vDOT, on improving patient outcomes in TB/HIV patients in South Africa.

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.Check my eligibility

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.See study design

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.

LEAP-TB-SA Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 or older and have pulmonary TB.

Select...

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

LEAP-TB-SA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of deaths among participants

Number of participants lost to follow-up

Number of participants with treatment failure

+1 more

Secondary outcome measures

Time to linkage to care

Time to treatment initiation

LEAP-TB-SA 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Witwatersrand, South AfricaOTHER

98 Previous Clinical Trials

9,944,274 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,256 Previous Clinical Trials

14,820,009 Total Patients Enrolled

Jason E Farley, PhD, MPHPrincipal InvestigatorJohns Hopkins University School of Nursing

1 Previous Clinical Trials

68 Total Patients Enrolled

Media Library

CHW mHealth patient intervention for trigger escalation Clinical Trial Eligibility Overview. Trial Name: NCT04298905 — N/A

HIV/AIDS Research Study Groups: mHealth intervention, Standard of Care

HIV/AIDS Clinical Trial 2023: CHW mHealth patient intervention for trigger escalation Highlights & Side Effects. Trial Name: NCT04298905 — N/A

CHW mHealth patient intervention for trigger escalation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298905 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being enrolled in this experiment?

"Affirmative. According to records on clinicaltrials.gov, this medical study is presently enrolling participants with the initial posting occurring on March 10th 2022 and a recent update also taking place then. The trial aims to include 200 patients from 1 site in total."

Answered by AI

Are there any opportunities for enrolment in this trial right now?

"Per the information presented on clinicaltrials.gov, this investigation is open to volunteers. It was initially submitted to the platform on March 10th 2022 and has since been modified accordingly."

Answered by AI

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