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

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: Completed
• Conditions: Adherence, Patient
• Intervention / Treatment: Device: Wisepill device

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: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Adherence in M/XDR-TB HIV outcomes	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	Retention in care will be assessed by loss to follow-up.	9-24 months
TB treatment outcomes	The number of participants with TB treatment outcomes as assessed by death or culture conversion.	9-24 months

Collaborators and Investigators

• Sponsor: Centre for the AIDS Programme of Research in South Africa
• Collaborators: Columbia University
• Investigators: Principal Investigator: Nesri Padayatchi, Deputy Director

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 29, 2018
• Primary Completion (ACTUAL): September 28, 2021
• Study Completion (ACTUAL): December 5, 2022

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (ACTUAL): July 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID 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