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临床试验/NCT02744521
NCT02744521Unknown不适用

Training Inmate Peer Educators in Detecting Tuberculosis in Prisons

Maastricht University0 个研究点开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
主要终点
Tuberculosis case detection rate (CDR)

研究概览

简要总结

Introduction: Finding and successfully treating all tuberculosis (TB) patients is the cornerstone of the Global Strategy to Stop TB. However, many patients in resource-limited countries remain undiagnosed. Prisons are a well-known source of undetected TB. Thus, there is a need to find feasible interventions to find and treat TB patients in these settings.

Objective: The objective of this study is to evaluate whether empowering and involving inmate peer educators in TB control has an impact on increasing TB case detection rate and improving treatment success in resource-limited prison settings.

Methodology: This is a matched cluster randomized control trial where randomization to the intervention and treatment groups will be carried out within pairs. Eight matched prison pairs will be randomly selected for this study in which eight prisons from each pair will be randomly assigned to the intervention and the remaining to the control group. Trained prison peer educators at the intervention sites will organize and provide education about TB every two weeks on a regular basis for one year. Peer educators will also perform routine TB screening, using a screening protocol to identify presumptive TB cases for a referral. Identified presumptive TB cases will then be linked to the prison health personnel for a referral to nearby hospitals. The TB diagnosis will be carried out at the referral sites using the routine direct smear microscopy and/or chest X-ray (Radiography). Tuberculosis case finding in the control sites will follow the existing referral system (self-referral to nearby hospitals) and the diagnosis will be undertaken using direct sputum microscopy and/or chest X-ray as in the intervention sites. The data will be entered using Epi Data entry version 3.1 software and analyzed using SPSS version 20.0. Considering prisons as a unit of analysis, the mean Case Detection Rate (CDR), Treatment Success Rate (TSR) and the percentage of patients symptomatic for > =3 months will be compared within pairs using the paired t-test or sign test as appropriate.

详细描述

  1. Background and justification

Although the global incidence of tuberculosis (TB) has fallen by an average rate of 1.5% per year between the years 2000 and 2013, TB remains a major global health problem and is the second leading cause of death from infectious diseases [1,2]. An estimated 9 million people had developed TB in the year 2013 of which one-quarter was from Africa, the continent that also has the highest rates of cases and deaths relative to its population [1,3]. In the same year, only 5.7 million cases were both detected and notified to the National TB programs (NTPs), meaning that about 3 million people were "missed" by TB control programs [1]. The TB case detection rate (calculated as notifications of new and relapse cases divided by the estimated incidence per year) was only 64% at the global level and is below the World Health Organization (WHO) target (70%) [1].

Tuberculosis disproportionately affects vulnerable populations such as prisoners. According to a review of studies from both high and low-income countries, the prevalence of TB in prisons was 3 to 200-fold higher than in the general population [4,5]. A number of factors such as overcrowding, inadequate ventilation, delayed case detection and the movement of prisoners from site to the site make prisons a high-risk environment for TB transmission [6]. The emergence of drug-resistant TB has also made TB control efforts very complicated in prisons. [7]. If untreated, prisoners with drug-resistant TB will be an additional health hazard for fellow prisoners and staff [8]. Furthermore, TB and resistant forms of TB can spill out into the community and create a public health hazard [9]. In sub-Saharan African prisons, the high burden of human immunodeficiency virus (HIV) infection and poverty make the problem much worse [10]. Health care services are also very limited and due to the lack of diagnostic facilities many TB patients remain undetected [11]. In a recent study from a South African prison, for example, the prevalence of undiagnosed TB was reported to be high at 3.5% [12].

Ethiopia, which ranks 8th of the 22 countries with a high burden of TB [13], has implemented the directly observed treatment short-course (DOTS) program since 1992 [14]. Currently, the country has achieved the Millennium Development Goals (MDGs) of halving TB incidence, prevalence, and mortality by 2015 [1]. However, the case detection rate (CDR) remains low as in many other developing countries.

The case detection rate of all forms of TB was reported to be 62% which is still below the WHO target [1]. Ethiopia is listed among the top ten countries that accounted for 74% (2.4% million) of missed TB cases [1]. Shortage of health workers, low service coverage, low health seeking behavior and lack of efficient TB diagnostics are some of the factors for the low case detection rate in the country [15].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age of 18 years or more.

排除标准

  • 未提供

研究组 & 干预措施

control

No Intervention

Symptom based screening intervention

Experimental

干预措施: Symptom-based screening intervention (Other)

结局指标

主要结局

Tuberculosis case detection rate (CDR)

时间窗: One year

Calculated as notifications of new and relapse cases divided by the estimated incidence per year. The mean CDR will be compared within each pair at the end of the intervention (after 12 months).

次要结局

  • Pre-treatment symptom duration(One year)
  • Treatment success rate (TSR)(One year)

研究者

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

Kelemework Adane

Mr

Maastricht University

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