PREVENT TB: Improving determinants of TB cure, prevention & diagnosis

PREVENT TB: Improving determinants of TB cure, prevention and diagnosis with a Community Randomised Evaluation of a Socioeconomic Intervention to Prevent TB (CRESIPT)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17820976

Enrollment

2336

Registered

2016-10-19

Start date

2016-10-21

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis Respiratory Tuberculosis

Interventions

Communities (clusters) are allocated to be 'supported' (n=16) or 'comparison' (n=16) in a 1:1 ratio by restricted randomisation. The principal restriction variables are: average case notification rate

average cluster-level percentage registered to receive national health insurance

average cluster-level percentage of TB cases lost to follow-up

and average cluster-level percentage of TB cases resistant to any drugs. All communities: Patients with TB and their household members in all 32 communities (16 supported and 16 comp

and?2. Economic support constituting cash transfers as incentives and enablers, defraying household's average TB-related costs.? Comparison communities: Patients with TB and their hou

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients living in the 32 communities participating in the study who are commencing or have within the past 6 weeks commenced TB treatment at National TB Program health posts, and their household members, who are able and willing to give informed written consent/assent to participate in this trial, including completing the recruitment questionnaire and recruitment household visit.

Exclusion criteria

Exclusion criteria: Patients who were taking a previous course of TB treatment and then experienced an adverse TB treatment outcome that occurred after the trial start date.

Design outcomes

Primary

Measure	Time frame
1. “Cure TB long-term.” A composite adverse treatment outcome* in patients with TB, as measured through reviewing TB program records when patient treatment ends, and follow-up constituting an interview for self-reported incident TB and a prevalence survey to test for laboratory proven prevalent TB 18 months after recruitment * The composite adverse treatment outcome is defined as any of:? death attributed to TB at any time or death from any cause during TB treatment; loss to follow-up during treatment as defined by the TB program (treatment ‘abandoned’ for =30 days); treatment failure as defined by the TB program; or TB recurrence defined as any repeat TB diagnosis after recruitment? Patients who at follow-up are still adhering to ongoing TB treatment (e.g. during prolonged treatment for MDR TB) and have not developed any of these adverse treatment outcomes are considered not to have had an adverse outcome and are included in the analysis. Patients whose TB treatment outcome is unknown are excluded e.g. because their treatment was transferred elsewhere. 2. “Find TB in those at high risk.” TB diagnosis in the household members of patients with TB during the first 8 weeks from when the patient with TB commenced treatment is measured by reviewing TB program records when patient treatment ends, and follow-up constituting an interview for self-reported incident TB 18 months after recruitment? 3. “Prevent TB in patient households.” TB diagnosis in the household members of patients with TB at any time from 8 weeks after the patient with TB commenced treatment is measured by reviewing TB program records when patient treatment ends, and follow-up constituting an interview for self-reported incident TB and a prevalence survey to test for laboratory proven prevalent TB 18 months after recruitment	—

Measure

Time frame

1. “Cure TB long-term.” A composite adverse treatment outcome* in patients with TB, as measured through reviewing TB program records when patient treatment ends, and follow-up constituting an interview for self-reported incident TB and a prevalence survey to test for laboratory proven prevalent TB 18 months after recruitment * The composite adverse treatment outcome is defined as any of:? death attributed to TB at any time or death from any cause during TB treatment; loss to follow-up during treatment as defined by the TB program (treatment ‘abandoned’ for =30 days); treatment failure as defined by the TB program; or TB recurrence defined as any repeat TB diagnosis after recruitment? Patients who at follow-up are still adhering to ongoing TB treatment (e.g. during prolonged treatment for MDR TB) and have not developed any of these adverse treatment outcomes are considered not to have had an adverse outcome and are included in the analysis. Patients whose TB treatment outcome is unknown are excluded e.g. because their treatment was transferred elsewhere. 2. “Find TB in those at high risk.” TB diagnosis in the household members of patients with TB during the first 8 weeks from when the patient with TB commenced treatment is measured by reviewing TB program records when patient treatment ends, and follow-up constituting an interview for self-reported incident TB 18 months after recruitment? 3. “Prevent TB in patient households.” TB diagnosis in the household members of patients with TB at any time from 8 weeks after the patient with TB commenced treatment is measured by reviewing TB program records when patient treatment ends, and follow-up constituting an interview for self-reported incident TB and a prevalence survey to test for laboratory proven prevalent TB 18 months after recruitment

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Secondary

Measure	Time frame
Secondary outcome measures 1 and 2 are measured at recruitment and compared with repeat measurement approximately 6 months after recruitment. Secondary outcome 3 is measured approximately 6-months after recruitment. 1. "Social empowerment" aiming to improve TB-related: 1.1. Knowledge gaps, measured using a questionnaire designed for the purpose of this study 1.2. Wellbeing, measured using the WHO EUROHISQOL-8 tool and Beck Depression Inventory 1.3. Marginalisation, measured using the World Bank SASCAT-derived social capital and EMIC stigma questionnaires 2. "Economic empowerment" aiming to improve TB-related: 2.1. Impoverishment, measured through the household composite poverty and dissaving score 2.2. Nutrition, measured through patient anthropometry and questionnaire-based food insecurity score 2.3. Costs, measured using a questionnaire evaluating net costs and catastrophic costs after subtracting cash transfers 3. "Empowering equitable access" to TB program care aiming to improve: 3.1. Patient adherence, measured using TB program records as the proportion of patient treatment doses missed 3.2. Screening, measured using TB program records as the proportion of household members of patients with TB who do not complete TB screening 3.3. Preventive therapy, measured using TB program records as the number of weeks of TB preventive therapy taken by the household members of patients with TB. Exploratory outcome: “Control TB”: Changes in community case notification rates defined as a numerator of all TB cases notified by the NTP divided by a denominator of community population size is estimated by the regional ministry of health (based on the national census data) calculated for each community per 100,000 person years. All cases diagnosed only in	—

Measure

Time frame

Secondary outcome measures 1 and 2 are measured at recruitment and compared with repeat measurement approximately 6 months after recruitment. Secondary outcome 3 is measured approximately 6-months after recruitment. 1. "Social empowerment" aiming to improve TB-related: 1.1. Knowledge gaps, measured using a questionnaire designed for the purpose of this study 1.2. Wellbeing, measured using the WHO EUROHISQOL-8 tool and Beck Depression Inventory 1.3. Marginalisation, measured using the World Bank SASCAT-derived social capital and EMIC stigma questionnaires 2. "Economic empowerment" aiming to improve TB-related: 2.1. Impoverishment, measured through the household composite poverty and dissaving score 2.2. Nutrition, measured through patient anthropometry and questionnaire-based food insecurity score 2.3. Costs, measured using a questionnaire evaluating net costs and catastrophic costs after subtracting cash transfers 3. "Empowering equitable access" to TB program care aiming to improve: 3.1. Patient adherence, measured using TB program records as the proportion of patient treatment doses missed 3.2. Screening, measured using TB program records as the proportion of household members of patients with TB who do not complete TB screening 3.3. Preventive therapy, measured using TB program records as the number of weeks of TB preventive therapy taken by the household members of patients with TB. Exploratory outcome: “Control TB”: Changes in community case notification rates defined as a numerator of all TB cases notified by the NTP divided by a denominator of community population size is estimated by the regional ministry of health (based on the national census data) calculated for each community per 100,000 person years. All cases diagnosed only in

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Countries

Peru

Contacts

Public ContactCarlton Evans

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026