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.
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.
Study Type
OBSERVATIONAL
Enrollment
199
King Dinuzulu Hospital
Durban, KwaZulu-Natal, South Africa
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.
Time frame: 6 months
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
Time frame: 6 months
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.
Time frame: 6 months
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