Socioeconomic support for people with tuberculosis and their households Respiratory Tuberculosis
Conditions
Interventions
POPULATION: the pilot trial will recruit 120 people with TB notified to the Nepal National TB Program (NTP). The integrated process evaluation will recruit 40 multisectoral stakeholders including NTP
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. PEOPLE WITH TB 1.1. People 18 years of age or older 1.2. A person or guardian of a person notified to the Nepal National TB Program and registered in the TB register of a TB clinic within the study site district 1.3. A person or guardian of a person with TB will be eligible to be included regardless of the site of TB (e.g. intrapulmonary or extrapulmonary), HIV serostatus (e.g. HIV positive, HIV negative, or HIV status unknown), resistance profile (e.g. drug-sensitive TB [DS-TB] or drug-resistant TB [DR-TB]), or disability 1.4. A person or guardian of a person who is able to provide written, informed consent or assent (or thumb print if unable to write) MULTISECTORAL STAKEHOLDERS TO PARTICIPATE IN PROCESS EVALUATION FGDS, KIIS, AND WORKSHOP A scoping exercise will establish existing social and/or economic support provided to TB-affected or other households in the study site communities and identify a list of key in-country stakeholders in Nepal. The stakeholders will be from diverse groups including: civil-society organisation (CSO) representatives including from cooperatives, women’s groups, grass roots organisations; community leaders (e.g. district elders); social-protection decision makers; NTP leaders and managers; and NTP multi-disciplinary staff, predominantly from the study sites. Additional stakeholders will be ASCOT field team members including community mobilisers (CMs), female community health volunteers (FCHVs), and District Program Coordinators (DPCs); and a subset of people with TB recruited to each arm of the ASCOT study will be purposively selected. Purposive selection will aim to achieve representation by gender, age, poverty level, comorbidities (e.g. HIV), and ASCOT arm. The following stakeholders will be invited to participate in separate focus group discussions (FGDs): CSO representatives (n=5) Community leaders (n=5) NTP multi-disciplinary staff (n=5) ASCOT CMs (n=5)• ASCOT FCHVs (n=5) People with TB (separate FGDs of n=5 with participants from each study arm) The following stakeholders will be invited to participate in key informant interviews (KIIs): NTP managers (n=5) Social protection decision makers (n=5) ASCOT DPCs (n=5) 2. STAKEHOLDER INCLUSION CRITERIA 2.1. People 18 years of age or older 2.2. Identified by desk-based scoping review or, if a person with TB or the guardian of a person with TB, participated in ASCOT pilot trial 2.3. Able to provide written, informed consent (or thumb print if unable to write)
Exclusion criteria
Exclusion criteria: 1. PEOPLE WITH TB 1.1. People under 18 years of age 1.2. Another member of the potential trial participant’s household is already a participant in the ASCOT study 1.3. A person or guardian of a person not notified to Nepal National TB Program and not registered in the TB register of a TB clinic within the study site district 1.4. A person or guardian of a person who is unable to provide written, informed consent or thumb print In addition to the above, pilot trial participants who receive an alternative diagnosis during their treatment (e.g. diagnosis of TB rescinded and, in some cases, alternative non-TB diagnosis made) and are removed from the NTP register will also be excluded from further follow-up. 2. MULTISECTORAL STAKEHOLDERS 2.1. People under 18 years of age 2.2. Not identified by scoping review or, if a person with TB or the guardian of a person with TB, did not participate in ASCOT pilot trial 2.3. Unable to provide written, informed consent or thumb print
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be feasibility and acceptability of the ASCOT support intervention. Acceptability will be measured using mixed-methods including: 1. Quantitative analysis of the implementer (end of participant recruitment) and user satisfaction form (2 and 6 months following recruitment); 2. Quantitative analysis of 0, 2, and 6 month survey data and project records to establish fidelity to the intervention (e.g. adherence to and completion of socioeconomic support delivery amongst intervention arm participants); and 3. Thematic analysis of the qualitative FGD and KII data collected within Sekhon’s Framework for healthcare interventions. Feasibility will be measured using quantitative data analysed at the end of recruitment and follow-up including: 1. Recruitment (e.g. number of people invited, recruited, and participant attrition) 2. Survey completion 3. ASCOT staff time and costs plus overall project costs recorded throughout | — |
Secondary
| Measure | Time frame |
|---|---|
| Health systems readiness and scalability will be assessed using mixed-methods including thematic analysis of FGD and KII data. | — |
Countries
England, Nepal, United Kingdom
Contacts
Public ContactBhola Rai
Outcome results
None listed