Tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
Participants are randomised (stratified by clinic) using a randomised sequence generator performed by the trial statistician to one of two groups.
Those in the first group receive the PROLIFE package
Sponsors
South African Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients (18 years or older) with drug-sensitive pulmonary TB (PTB) 2. Current smokers OR hazardous/harmful drinkers who are not alcohol dependent (AUDIT score = 8 for men or = 7 for women but <20) 3. Initiating TB treatment or on current TB treatment for less than 1 month (these include both “new” and “retreatment patients”) 4. Access to a functional cellphone 5. Understands one of the 4 languages used for the trial (Sesotho, Setswana, Zulu or English)
Exclusion criteria
Exclusion criteria: 1. On TB treatment for more than one month 2. Alcohol dependent participants (AUDIT score more than or equal to 20) provided they are non-smokers 3. Extrapulmonary tuberculosis provided they don’t also have pulmonary tuberculosis 4. Drug resistance to one or more TB drugs at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 15/10/2021: TB treatment success rate measured according to treatment outcomes defined by the WHO and adopted in South Africa, at 6 to 9 months _____ Previous primary outcome measure: TB treatment success rate measured according to treatment outcomes defined by the WHO and adopted in South Africa, at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/10/2021: 1. Cure rates (determined by TB nurse by negative culture or smears at the end of treatment) in the group of participants who had bacteriology confirmed PTB at baseline 2. Sustained smoking abstinence measured using a self-report of not smoking more than 5 cigarettes from the start of the abstinence period, supported by a negative biochemical test (exhaled Carbon Monoxide <7) at 3 and 6 months 3. Reduction in harmful or hazardous drinking measured using the AUDIT questionnaire administered at baseline, 3 and 6 months 4. TB medication and ART adherence are measured using a modified version of the AIDS Clinical Trials Group (ACTG) Adherence Questionnaire (to include TB medication adherence) administered by field workers at baseline, at 3 and 6 months 5. Proportion of HIV-positive participants on ART recorded as per the TB Treatment Record at 3 and 6 months. HIV positive participants will be asked about ART status at baseline, 3 months and 6 months using standardized questions on the CRF. _____ Previous secondary outcome measures: 1. Sputum conversion measured by negative culture or smears in the group of participants who had bacteriology confirmed PTB at baseline at the end of treatment 2. Sustained smoking abstinence measured using a self-report of not smoking more than 5 cigarettes from the start of the abstinence period, supported by a negative biochemical test (exhaled Carbon Monoxide <7) at 3 and 6 months 3. Reduction in harmful or hazardous drinking measured using the AUDIT questionnaire administered at baseline, 3 and 6 months 4. TB medication and ART adherence are measured using a modified version of the AIDS Clinical Trials Group (ACTG) Adherence Questionnaire (to include TB medication adherence) administered by field workers at baseline, 3 and 6 months 5. Proportion of HIV-positive participants on ART recorded as per the TB Treatment Record at baseline, 3 and 6 months. HIV positive participants will be | — |
Countries
South Africa
Outcome results
None listed