ISRCTN17025974已完成未知
Addressing the Social Determinants and Consequences of Tuberculosis: a pilot randomised controlled trial with mixed-methods process evaluation in Nepal
iverpool School of Tropical Medicine0 个研究点目标入组 128 人开始时间: 2021年8月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 128
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36874579/ protocol 17669.3 (added 08/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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