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Completed

NCT Number: NCT04032730

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Dinuzulu Hospital

Durban, KwaZulu-Natal, South Africa

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnancy
  • Prisoners
  • Discretion of IOR or clinician

Treatment and study plan

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.

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

Primary outcomes

  1. 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

  2. Retention in care

    Time frame: 9-24 months

    Retention in care will be assessed by loss to follow-up.

  3. TB treatment outcomes

    Time frame: 9-24 months

    The number of participants with TB treatment outcomes as assessed by death or culture conversion.

Sponsors and collaborators

Lead sponsor

Centre for the AIDS Programme of Research in South Africa

Network

Collaborators

  • Columbia University

Registry information

Official study title

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

Acronym: PRAXIS

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jul 25, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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