Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study (PRAXIS)

February 7, 2023 updated by: Dr Nesri Padayatchi, Centre for the AIDS Programme of Research in South Africa

Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study (PRospective Study of Adherence in M/XDR-TB Implementation Science) Aim 2

The goal of the proposed study is to enhance adherence and retention in care for M/XDR-TB HIV patients through enhanced standard of care, targeted transition to outpatient medication self-administration prior to hospital discharge, and use of community adherence groups, with an overarching goal of promoting patient engagement in a care continuum.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people living with HIV (1). Globally, the incidence of multidrug-resistant tuberculosis (MDR-TB) and extensively drug resistant tuberculosis (XDR-TB), the most drug-resistant forms of TB, has approximately doubled over the past fifteen years (1-3). Nowhere has this increased incidence generated more concern than in South Africa where interactions between TB and generalized HIV epidemics are causing 'explosive' TB incidence (4-6) and case-fatality are threatening to undermine the progress reached with antiretroviral therapy (ART) (7, 8).

Medication adherence, a key predictor of outcomes in M/XDR-TB and HIV treatment, is understudied in high burden TB-HIV settings (9-11). Patient losses during transitions in the care continuum are frequent (12), increase mortality and limit control of the linked epidemics. Demands of M/XDR-TB HIV treatment are severe including extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern medicine (13-15).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
171

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa
        • King DinuZulu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. MTB culture positive with at least isoniazid and rifampicin resistance OR Molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin OR Polymerase chain reaction test (Xpert MTB/RIF) result showing MTB positive and RIF resistance. OR MTB positive with Rifampicin monoresistance
  3. Initiating treatment for M/XDR-TB which includes Bedaquiline (BDQ) or Moxifloxacin/Levaquin
  4. Have capacity for informed consent
  5. HIV Positive Patients: on ART or initiating ART within the following 4 weeks as per clinician recommendation

Exclusion Criteria:

  1. Pregnancy
  2. Prisoners
  3. Discretion of IOR or clinician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control
Participants assigned to the control arm will undergo treatment and care for MDR/XDR-TB as per the South African Department of Health guidelines.
EXPERIMENTAL: Intervention
Participants assigned to the intervention arm will undergo extensive counselling, participants will be provided with an electronic pillbox that monitors their adherence to one of their TB and one of their ART medication. Based on the recordings provided by the wisepill device we will determine if a participant is adherent to their medication and intervene with counselling, phone calls, home visits and relevant referrals.
Device: Wisepill device

Participants will receive a Wisepill device for TB and ART medications. Participants will receive an exit counselling session prior to being discharged.

Participants will select the content of a text message to be sent when missing a dose as measured by Wisepill non-opening during medication dose-window.

Participants will receive a post-discharge phone call by study staff for the purpose of identifying any early challenges or obstacles. All participants may receive a titrated Wisepill intervention (TWI) consisting of a text message, phone call, and/or study home visit triggered by medication non-adherence as detected by Wisepill non-opening.

All participants will receive a monthly counselling intervention (MCI). Adherence support groups (ASG) will be conducted on a monthly basis.

Other Names:
  • Home Visits
  • Adherence Support Groups
  • Monthly Counselling Intervention
  • Titrated Wisepill Intervention
  • Exit Counselling for Discharged patients
  • Post Discharge Phone Calls

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence in M/XDR-TB HIV outcomes
Time Frame: 9-24 months

The number of participants that are adherent to their TB and ARV medication as assessed by:

  • the use of wisepill device (electronic pill box). 2 wisepill devices are provided to participants in the intervention arm, one for their ART medication and one for their TB medication (namely Bedaquiline).
  • By self reporting via 7-day recall and 30-day recall
  • By self reporting via Visual analogue scale
9-24 months
Retention in care
Time Frame: 9-24 months
Retention in care will be assessed by loss to follow-up.
9-24 months
TB treatment outcomes
Time Frame: 9-24 months
The number of participants with TB treatment outcomes as assessed by death or culture conversion.
9-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for the AIDS Programme of Research in South Africa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nesri Padayatchi, Deputy Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAP 086 AIM 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings