Adaptive Evaluation of mHealth and Conventional Adherence Support Interventions to Optimize Outcome With New Treatment Regimens for Drug-resistant Tuberculosis and HIV in South Africa
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Columbia University
- Enrollment
- 360
- Locations
- 2
- Primary Endpoint
- Biological outcome
Study Overview
Brief Summary
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (INSTI)-based fixed dose combination therapy) in KwaZulu-Natal, South Africa. Interventions arms include: enhanced standard of care; psychosocial support; mHealth using cellular-enabled electronic dose monitoring; combined mHealth psychosocial support. Level of support will be adjusted using a differentiated service delivery (DSD)- informed assessment of treatment support needs.
Detailed Description
This study will follow a 4-arm Bayesian, adaptive trial design. As patients are enrolled, they will be randomized into one of the four arms.
The study will be carried out within a common structure to allow for efficient enrollment and analysis. The overall structure is a 4-arm adaptive platform of mHealth and psychosocial adherence support interventions informed by a differentiated service delivery (DSD) approach.
Aim 1 is an adaptive study of mHealth and psychosocial adherence support interventions using a Bayesian adaptive design to allow comparison of elements of the intervention separately and in combination. Aim 1 participants will be randomized into one of 4 arms and followed monthly through the 6 months of intervention, then through the end of treatment telephonically, with an additional in-person visit to establish the primary outcome. Primary outcome is a combined clinical/biological outcome at 12 months described below. Hypothesis 1a utilizes all participants while 1b utilizes only those in the mHealth intervention arms (3+4) since granular EDM-measured adherence is required.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Culture or molecular test positive for MTB
- •Molecular test positive for HIV or a documented HIV positive history
- •Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB,
- •Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ
- •On treatment with Antiretroviral Therapy (ART) regimen, including dolutegravir-containing combination Antiretroviral Therapy regimen (i.e. Tenofovir-Lamivudine-Dolutergravir), or starting within 4 weeks of enrollment,
- •Capacity for informed consent in either isiZulu or English
Exclusion Criteria
- •Discretion of IOR or clinician
Arms & Interventions
Enhanced standard of care
- Care from trained and supported physicians, nurses, and social workers who have received repeated trainings from study staff on medical and behavioral aspects of DR-TB HIV care, which will be documented in terms of date, attendance, and content
- All participants who receive care as inpatients will receive an orientation to DR-TB treatment in form of a group session designed to impart key behavioral information and health knowledge about the disease, treatment, and skills to obtain optimal outcome.
- Discharge counselling session will be conducted prior to discharge.
- Study participants will complete study assessments at baseline (enrollment) and monthly for the first six months.
Psychosocial support
- In addition to Arm 1
- Participants will participate in individual counseling aligned with their monthly clinic visit.
- Individual counseling will use motivational interviewing (MI) techniques, based on the 4-part engaging, focusing, evoking and planning approach for each participant.
- Home visits will be conducted (if warranted/consented for by the participant) by the same trained counselors known to patients.
- Adherence support groups will be facilitated by counselors trained in group facilitation methods; group curriculum will include 6 sessions (monthly, gender specific, structured adherence support groups) that focus on practical topics.
- Discharge planning (if inpatient)
- Community treatment planning (if outpatient)
Intervention: Adherence support intevention (Behavioral)
mHealth
- In addition to Arm 1
- Participants will receive x 2 portable Wisepill devices. (x1 for MDR-TB treatment and x1 for ART).
A Wisepill device is an RT2000 cellular-enabled electronic pill boxes using 2G/3G cellular network.
- Participants will select a text message reminder from a guided menu of choices and receive a weekly text message encouraging adherence.
- Participants will receive a study call to support regular adherence. Participants will be assessed weekly. Less than 85% observed/expected doses will be considered at risk for non-adherence and the intervention will be increased.
Intervention: Adherence support intevention (Behavioral)
mHealth and Psychosocial support
Combination of Arm 2 and Arm 3.
Intervention: Adherence support intevention (Behavioral)
Outcomes
Primary Outcomes
Biological outcome
Time Frame: 12 months
HIV viral load
Clinical outcome
Time Frame: 12 months
Survival
Secondary Outcomes
No secondary outcomes reported
Investigators
Max O'Donnell
Associate Professor of Medicine and Associate Professor of Epidemiology
Columbia University