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

  • STATUS
    Recruiting
  • End date
    Apr 29, 2022
  • participants needed
    400
  • sponsor
    Centre for the AIDS Programme of Research in South Africa
Updated on 23 January 2021

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.

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).

Details
Condition Patient Compliance
Treatment Wisepill device
Clinical Study IdentifierNCT04032730
SponsorCentre for the AIDS Programme of Research in South Africa
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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