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AzTrials

Patient Non-compliancePRAXISNCT03162107

Promoting Engagement in the Drug Resistant TB/HIV Care Continuum in South Africa

An observational study of Patient Non-compliance, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goals of this research are to understand adherence and retention in care for multi-and extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Patient Non-compliance
How many people
199 participants
Where
1 siteSouth Africa
Study dates
Dec 2016to 16 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Adult patients with newly diagnosed active pulmonary multi- and extremely-drug resistance tuberculosis (M/XDR-TB) (≥ 18 years old), admitted for routine care at King DinuZulu Hospital in Durban, South Africa will be approached for enrollment. Only patients with capacity for consent will be included in the study. Healthcare workers will be approached for participation in focus group discussions.

Who may be able to join

  • Age ≥ 18 years
  • Mycobacterium Tuberculosis (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 (GeneXpert MTB/RIF) result showing MTB positive and RIF resistance. Patients enrolled with only a GeneXpert MTB/RIF result will be withdrawn if their subsequent susceptibility test or molecular drug susceptibility test reveals rifampicin monoresistance.
  • Initiating treatment for M/XDR-TB which includes at least 2 new medications
  • Have capacity for informed consent
  • HIV Positive Patients: on antiretroviral therapy (ART) or initiating ART within the following 4 weeks as per clinician recommendation

Who cannot join

  • Pregnancy
  • Prisoners
  • Discretion of the Investigator of Record or clinician

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • King Dinuzulu Hospital

    Durban, KwaZulu-Natal

Other trials in South Africa

About this study

Official 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)

The goals of this research are to understand adherence and retention in care for multi-and extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach.

Read the detailed description

Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people living with HIV. Globally, 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. 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 and case-fatality threatening to undermine the progress reached with antiretroviral therapy (ART).

Medication adherence, a key predictor of outcomes in multi-and extensively drug-resistant tuberculosis (M/XDR-TB) and HIV treatment, is understudied in high burden TB/HIV settings. Patient losses during transitions in the care continuum are frequent, 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.

This is a prospective observational cohort study for patients newly diagnosed with M/XDR-TB initiating treatment. A mixed method approach will be employed to address the complex research questions of distilling determinants of barriers and facilitators to both TB medications and ART; this study will employ complementary qualitative and quantitative methodologies for assessing differential adherence to TB medications and ART.

A sub-set of patients and health care workers will be approached for participation in focus group discussions.

Keywords
adherence, HIV, MDR/XDR TB, Health Care Worker
Medical subject headings
Patient Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication adherence based on electronic monitoring

    An electronic monitoring system (e.g., Wisepill technologies) will be used to measure adherence to antiretroviral therapy and treatment of multi- and extremely-drug resistant tuberculosis.

    Measured: 6 months

Secondary outcomes (2)

  1. Medication adherence based on self-report

    Quantitative adherence will be measured using 30 day and 7 day recall. Average adherence to both antiretroviral therapy and tuberculosis treatment will be calculated for each patient

    Measured: 6 months

  2. Sociomedical risk factors associated with six-month adherence to ART or TB medications

    Barriers and facilitators to medication adherence and retention in care for M/XDR-TB HIV patients will be identified through in-depth interviews and focus group discussions with patients and health care workers. To identify sociomedical risk factors associated with six-month adherence to ART or TB medications we will first identified risk factors associated with adherence in bivariate analysis and then multiple logistic regression models will be constructed including variables which are statistically significant and/or associated with >10% change in effect measure.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2017
  2. Study startDec 2016
  3. Primary completion10 Jan 2020
  4. Study completion16 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03162107
Sponsor's protocol ID
CAP 086
Acronym
PRAXIS
Status last verified
Jul 2022
First submitted
24 Mar 2017
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bateman M, Wolf A, Chimukangara B, Brust JCM, Lessells R, Amico R, Boodhram R, Singh N, Orrell C, Friedland G, Naidoo K, Padayatchi N, O'Donnell MR. Adherence Measured Using Electronic Dose Monitoring is Associated with Emergent Antiretroviral Resistance and Poor Outcomes in People with Human Immunodeficiency Virus/AIDS and Multidrug-Resistant Tuberculosis. Clin Infect Dis. 2022 Oct 29;75(9):1489-1496. doi: 10.1093/cid/ciac232.

    PubMed 35352097

Questions about this trial

What is this clinical trial studying?

An observational study of Patient Non-compliance, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication adherence based on electronic monitoring (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03162107, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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