Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
360 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-03-07
Study Completion Date
2029-04-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Multi Drug Resistant Tuberculosis
HIV Infections
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
An adaptive, randomized controlled trial comparing the effectiveness of 4 adherence support intervention arms. 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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
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)
Group Type
OTHER
Adherence support intevention
Intervention Type
BEHAVIORAL
Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.
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.
Group Type
OTHER
Adherence support intevention
Intervention Type
BEHAVIORAL
Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.
mHealth and Psychosocial support
Combination of Arm 2 and Arm 3.
Group Type
OTHER
Adherence support intevention
Intervention Type
BEHAVIORAL
Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.
Interventions
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Adherence support intevention
Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
1. Culture or molecular test positive for MTB
2. Molecular test positive for HIV or a documented HIV positive history
3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB,
4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ
5. 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,
6. Capacity for informed consent in either isiZulu or English
2. Molecular test positive for HIV or a documented HIV positive history
3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB,
4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ
5. 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,
6. Capacity for informed consent in either isiZulu or English
Exclusion Criteria
1. Pregnancy
2. Prisoners
3. Discretion of IOR or clinician
2. Prisoners
3. Discretion of IOR or clinician
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Centre for the AIDS Programme of Research in South Africa
NETWORK
Sponsor Role
collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
collaborator
Columbia University
OTHER
Sponsor Role
lead
Responsible Party
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Max O'Donnell
MD,MPH,Principal investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Max O'Donnell, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Columbia
Locations
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King DinuZulu Hospital
Durban, KwaZulu-Natal, South Africa
Site Status
RECRUITING
Countries
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South Africa
Central Contacts
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Facility Contacts
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References
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Ross J, Perumal R, Wolf A, Zulu M, Guzman K, Seepamore B, Reis K, Nyilana H, Hlathi S, Narasimmulu R, Cheung YKK, Amico KR, Friedland G, Daftary A, Zelnick JR, Naidoo K, O'Donnell MR. Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): study protocol for an adaptive randomized controlled trial. Trials. 2023 Dec 1;24(1):776. doi: 10.1186/s13063-023-07520-9.
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DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Informed Consent Form: Informed Consent Form-English
Document Type: Informed Consent Form: English version
Related Links
Access external resources that provide additional context or updates about the study.
https://www.who.int/teams/global-tuberculosis-programme/the-end-tb-strategy
WHO World Health Organization. The end of TB strategy.2015
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAP262
Identifier Type: OTHER
Identifier Source: secondary_id
AAAT8513
Identifier Type: -
Identifier Source: org_study_id
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