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

NCT04032730 | Completed DMC

• 1 other identifier: CAP 086 AIM 2
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adherence, Patient

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control

NO INTERVENTION

Participants assigned to the control arm will undergo treatment and care for MDR/XDR-TB as per the South African Department of Health guidelines.

Intervention

EXPERIMENTAL

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

Interventions

Wisepill device 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.

Also known as: Adherence Support Groups, Monthly Counselling Intervention, Home Visits, Titrated Wisepill Intervention, Exit Counselling for Discharged patients, Post Discharge Phone Calls

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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
• Initiating treatment for M/XDR-TB which includes Bedaquiline (BDQ) or Moxifloxacin/Levaquin
• Have capacity for informed consent
• HIV Positive Patients: on ART or initiating ART within the following 4 weeks as per clinician recommendation

You may not qualify if:

• Pregnancy
• Prisoners
• Discretion of IOR or clinician

Sponsors & Collaborators

• Centre for the AIDS Programme of Research in South Africa: lead
• Columbia University: collaborator

Study Sites (1)

King Dinuzulu Hospital

Durban, KwaZulu-Natal, South Africa

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Nesri Padayatchi

  Deputy Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: July 25, 2019
• Study Start: April 29, 2018
• Primary Completion: September 28, 2021
• Study Completion: December 5, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

ZA (1)