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临床试验/NCT03832023
NCT03832023已完成不适用

Community Intervention for Tuberculosis Active Contact Tracing and Preventive Therapy - a Cluster Randomized Study (CONTACT)

Elizabeth Glaser Pediatric AIDS Foundation25 个研究点 分布在 2 个国家目标入组 1,400 人开始时间: 2019年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,400
试验地点
25
主要终点
Completion of preventive therapy

研究概览

简要总结

The many gaps observed in the cascade of care of tuberculosis (TB) child contacts occur mostly in the screening, preventive therapy (PT) initiation and PT completion steps and the main drivers of these gaps are considered to be the health system infrastructure, limited worker resources and parents' reluctance to bring their children to the facility for screening. There would be great advantages of using a symptom-based screening at community level where only the symptomatic contacts are referred to hospital for further evaluation and asymptomatic contacts are started on PT in the community. Household or community-based screening is likely to improve the uptake and acceptability of child contact screening and management as well as adherence to PT and to reduce cost and workload at facility level.

This study proposes to compare the cascade of care between two models for TB screening and management of household TB child contacts in two high TB burden and limited resource countries, Cameroon and Uganda. In the facility-based model, children will be screened at facility (Cameroon) or household level (Uganda) and preventive therapy initiation, refills of PT therapy and follow-up will be done at facility level. In the intervention group (community-based model), child contacts will be screened in the household by a community health worker (CHW). Those with symptoms suggestive of TB will be referred to the facility for TB investigations. Asymptomatic child contacts from high risk groups (under-5 years or HIV infected 5-14) will be initiated on PT (3 months isoniazid-rifampicin) in the household. Refills of PT therapy will also be done in the communities by the CHW. In both models, symptomatic children requiring further investigations for TB diagnosis will be referred to a health facility.

详细描述

The primary study objective is to compare the proportion of household child TB contacts eligible for PT (under-5 years and HIV-infected children 5-14 years without active TB) who initiate and complete PT using facility-based and decentralized community-based models of care for contact screening and management.

Secondary objectives are:

  1. To compare the facility and community-based models in terms of:
  • The full cascade of care for the initiation and completion of PT in child TB contacts < 5 years or HIV+ children 5-14 years .
  • Cascade of care for the detection and treatment of TB in child contacts (all ages):
  • PT tolerability and adherence among eligible child contacts initiated on PT.
  • Treatment uptake and outcomes for child contacts diagnosed with TB .
  • Child contact outcomes at 6 months after enrollment for all child contacts.
  • Acceptability by the parents/guardians, health personnel and community of the different models of care.
  • Cost and cost-effectiveness of the different models.
  • Fidelity of the implementation of the model activities as compared to the protocol.
  1. To assess the number of adult contact cases diagnosed with TB through the community-based screening.
  2. To compare between the pre- (baseline assessment) and post-intervention (by model of care) data related to:
  • Children diagnosed with TB and registered at facility level and their treatment outcome.
  • Adults diagnosed with TB and registered at facility level and their treatment outcome.
  • PT initiation and outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Inclusion of the index cases
  • •Age > 15 years
  • •Newly bacteriologically confirmed TB case (less than a month since diagnosis)
  • •Reports child contact(s)
  • •Written informed consent signed by the index case and by parents/guardians for minors or incapacitated people
  • •Inclusion of contacts
  • •Household contact
  • •Facility-based model in Cameroon: < 5 years or HIV infected 5-14 years and all self-referred adults or children*.
  • •Facility-based model in Uganda and community-based model on both countries: all ages
  • •Written informed consent signed by adult contacts and by parents/guardians for minors or incapacitated people
  • •Written assent for children > 7 years in Cameroon and ≥8 years in Uganda
  • •Under the facility-based model in Cameroon, although there is no systematic request to screen adults or HIV-negative child contacts 5-14 years old, first inclusions showed that some of them came by themselves for TB screening. This justifies their inclusion in the study in order to ensure the completeness of data for all contacts screened under the facility-based model.

排除标准

  • •- Exclusion of index cases
  • •Index cases who do not have child household contacts living in the catchment area of one of the study clusters
  • •Index cases diagnosed with rifampicin resistance, multidrug-resistant (MDR) or extensively drug-resistant (XDR) TB *Index cases from a household screened within the CONTACT study and that does not declare child contacts from another household.*
  • •Index cases that are prisoners
  • •TB confirmed adult contacts cases living in the same household as an index case already enrolled in the study will not be included as new index cases unless they declare additional contacts from another household
  • •- Exclusion of the contacts
  • •If the contact is already on PT or on TB treatment

研究组 & 干预措施

Facility-based model

No Intervention

Standard of care of each country

Community-based model

Experimental

Screening and initiating preventive therapy in communities

干预措施: Screening and initiating preventive therapy in communities (Other)

结局指标

主要结局

Completion of preventive therapy

时间窗: 6 months

Proportion of child TB contacts \<5 years of age and HIV-infected children of 5-14 years of age who initiate and complete the PT of all child contacts \<5 years of age and HIV-infected children of 5-14 years of age declared by the index case

次要结局

  • Proportion of children diagnosed with TB(6 months)
  • Proportion of children with adverse event of interest(6 months)
  • Treatment adherence(6 months)
  • Treatment outcomes of children started on TB treatment(6 months)
  • TB treatment outcome of registered TB patients during pre-intervention period(2 years)
  • Completion rate of children started on PT intervention during pre-intervention period(2 years)
  • Number of household visits by CHW(2 years)
  • Number of children started on PT during pre-intervention period(2 years)
  • Preference for household visit versus facility visit(2 years)
  • Proportion of children with serious adverse events(6 months)
  • Reasons of refusal of household visit(2 years)
  • Proportion of adult contacts screened(1 month)
  • Proportion of children started on TB treatment(1 month)
  • Proportion of adults presumptive TB cases(1 month)
  • Proportion of children with presumptive TB(1 month)
  • Proportion of children screened(6 months)
  • Proportion of children eligible for PT(6 months)
  • Proportion of children investigated for TB(1 month)
  • Proportion of adults diagnosed with TB(1 month)
  • Proportion of children started on PT(6 months)
  • Proportion of children who did not complete PT(6 months)
  • TB case detection during pre-intervention period(2 years)
  • Proportion of children among all registered TB cases during pre-intervention period(2 years)
  • Proportion of parents/guardians who accept household visit(2 years)
  • Critical events experienced by CHW during household visit(2 years)
  • Transport cost for household visit by CHW(2 years)
  • Transport cost for parents/guardian for facility-based screening(2 years)
  • Time spent to perform household contact screening visit(2 years)
  • Proportion of delivered activities compared to the intended activities of the model(2 years)
  • Proportion of children diagnosed with TB(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maryline Bonnet

Research Director, MD PhD

Institut de Recherche pour le Developpement

研究点 (25)

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