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

NCT03162107 | Completed

• 1 other identifier: CAP 086
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient Non-compliance

Keywords

adherence; HIV; MDR/XDR TB; Health Care Worker

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (2)

• Medication adherence based on self-report

  6 months

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

  6 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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 Patients enrolled with only a GeneXpert MTB/RIF result will be withdrawn if their subsequent susceptibility test or molecular drug susceptibility test reveals rifampicin monoresistance.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

You may not qualify if:

• Pregnancy
• Prisoners
• Discretion of the Investigator of Record 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

Related Publications (1)

• 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.

  PMID: 35352097 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Hair samples PBMCs TB Isolates

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

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

Study Officials

• Nesri Padayatchi, MBChB

  Centre for the AIDS Programme of Research in South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: May 22, 2017
• Study Start: December 1, 2016
• Primary Completion: January 10, 2020
• Study Completion: August 16, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)