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临床试验/NCT03667079
NCT03667079已完成不适用

Integrating Community-directed Interventions to Eliminate Neglected Tropical Diseases Caused by Soil-transmitted Helminth Infections and Rabies in Tanzania

Washington State University2 个研究点 分布在 1 个国家目标入组 28,143 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28,143
试验地点
2
主要终点
proportion of people in each village receiving deworming treatment

研究概览

简要总结

The overarching goal of this project is the elimination of two neglected tropical diseases (NTD):

soil-transmitted helminthiasis and rabies. The specific objective of this pilot study was:

To determine whether the integrated delivery platform improved the cost-effectiveness and coverage of MDA targeting STH and rabies;

The investigators integrated two public health initiatives: 1) a mass drug administration (MDA) effort to eliminate neglected tropical diseases (NTD) caused by soil-transmitted helminths (STH), with 2) a community-valued mass dog rabies vaccination (MDRV) intervention to eliminate human and animal rabies, also a priority NTD of the World Health Organisation. The goal of MDA efforts targeting STH is to reduce worm burdens to very low levels below which self-sustaining transmission, and the public health consequences of STH, cease. Existing school-based delivery programs fail to reach all affected age groups, however, which results in ineffective coverage levels and persistence of STH. The goal of MDRV is to immunize 70% of dog populations, after which canine-mediated rabies is eliminated. MDRV programs are typically very popular, with all human age groups participating. The objectives of this project were to determine whether supplementing a strictly school-based MDA NTD control program with a community-wide strategy that is coupled to an MDRV program will result in a synergism that (a) improves coverage, reach and cost-effective delivery of MDA targeting STH and (b) improves coverage and cost-effective delivery of dog vaccination. To achieve this, research activities, comprised of post-intervention household questionnaire surveys, were carried out. In addition detailed cost data was collected.

详细描述

The study was carried out in the Ngorongoro District, Tanzania inhabited by semi-nomadic Maasai people. The remote area was chosen because MDRV and MDA are carried out annually in the region as separate programs. The MDA program delivers twice yearly deworming treatment to every primary school and is coordinated by the District Medical Office (DMO). The MDRV program vaccinates dogs annually and is coordinated by the District Veterinary Office. The MDA and MDRV carried out in this study constituted one cycle of the established MDA and MDRV in the target villages. The study took place between February and October 2016, however activities were suspended during the rainy season to avoid inclement weather from affecting participation.

The study focused on 24 villages. The target villages were located within the eight wards immediately surrounding the district's administrative centre and were selected through convenience. Each of the 24 villages were randomly assigned to one of three arms: i) Arm A (n = 8) received both MDA and MDRV; ii) Arm B (n = 8) received MDA only; iii) Arm C (n = 8) received MDRV only. All villages were equally likely to be assigned to each arm. As per the established MDA and MDRV programs, a nurse from the DMO and two village-based community health workers carried out the MDA whilst a rabies field team (a veterinarian, two field staff and a ward-based person) delivered the MRDV. STH and / or rabies awareness information was provided to respondents in the form of verbal disease avoidance advice.

Villages in this region cover a large area, and all are divided into sub-village units. Each intervention ('event') was delivered at the level of the sub-village using a 'central-point' strategy, which required villagers to travel from their homes to the central-point event to receive treatment. Village leaders estimated that hosting each sub-village event for one day would provide sufficient time for villagers to attend. Consequently each event was scheduled to last for one day, and the number of days the team(s) spent in each village equalled the number of sub-villages.

Arm A events comprised an MDA and a MDRV clinic hosted concurrently, while Arm B and Arm C events comprised only one clinic (MDA or MDRV, respectively). For Arm A villages, the MDA and MDRV delivery teams travelled together in one vehicle and set up the clinics close to each other. For Arm B and C villages, the MDA and MDRV teams travelled separately.

In order to allow comparison of the MDA with school-based delivery (second objective) the events were all hosted during the school term. In sub-villages with a primary school, the clinics were positioned outside the school grounds, whilst in sub-villages that did not have a primary school the clinics were located in a central location.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • All healthy non pregnant people

排除标准

  • Children attending clinics alone
  • Pregnant women

结局指标

主要结局

proportion of people in each village receiving deworming treatment

时间窗: 9 months

The proportion of people in each village receiving deworming treatment was measured using household questionnaire surveys

proportion of dogs in each village receiving rabies vaccination

时间窗: 9 months

The proportion of dogs in each village receiving rabies vaccination was measured using household questionnaire surveys

次要结局

  • time people spent traveling(9 months)
  • cost of delivery(9 months)
  • Comparison with the national school-based deworming program(9 months)

研究者

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

Felix Lankester

Research Associate Professor

Washington State University

研究点 (2)

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