Taenia Solium Elimination Versus Control: What is the Best Way Forward for Sub-Saharan Africa?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,900
- 试验地点
- 1
- 主要终点
- Change in porcine cysticercosis: in this One Health approach, the primary outcome is not a human measure
研究概览
简要总结
Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with significant economic and public health impacts, occurring primarily in developing countries. Humans are the carriers of the tapeworm (taeniosis); the normal intermediate pig host develops the metacestode larval stage (porcine cysticercosis). However, people can also act as accidental intermediate hosts and develop human cysticercosis or neurocysticercosis (NCC) when the central nervous system is involved.
The scattered efforts of researchers into evaluation of control programmes in Sub-Saharan Africa (SSA) have focussed on single control options. It is becoming clear that these stand-alone options have the potential to reduce the occurrence of the parasite, however either long term or more integrated efforts seem to be required to reach an elimination status.
The objective of the current study is to evaluate the cost-effectiveness/acceptability of elimination (to be achieved on a short term via integrated measures), and control (single measures, with an elimination goal on a longer term) of T. solium in a highly endemic area in SSA.
This intervention study will entail an elimination study arm in which multiple control options are combined (integrated) aiming at the final human host (Mass drug administration (MDA) and health education) and pig intermediate hosts (pig treatment and vaccination). In a second study arm a single control option will be carried out (pig treatment). In both study arms (health) education will be implemented. At baseline and in the final sampling year, prevalence of human taeniosis/cysticercosis and porcine cysticercosis will be determined in all study villages. Active ongoing surveillance and 6 monthly (biannual) human and pig sampling will be conducted in the elimination study arm, as well as two-yearly (biennial) sampling of the pig intermediate host in the control study arm. Additionally, (open ended) questionnaires and focus group discussions will be administered/held to obtain data on the cost of pig keeping, T. solium, the interventions and the perception/acceptability of the proposed control measures to the local communities.
详细描述
As T. solium is a zoonosis, it's control will be evaluated in a One Health perspective, tackling both the human and pig host. The study will be carried out in the Katete district, in the Eastern Province of Zambia, an area reported to be endemic for T. solium in both pigs and humans. The pig interventions will not be described here, as requested by ClinicalTrials.gov Suitability of communities in the Katete district was assessed during a pilot survey conducted by the proposers (April 2015).
Two communities were selected that fulfilled all of the eligibility criteria. The Nyembe neighbourhood community (1,210 people, 5 villages, 520 pigs), within the Nyembe Rural Health Centre (RHC) catchment was selected for the elimination study arm; and Chimvira neighbourhood community (1,470 people, 11 villages, 827 pigs), in the Mtandaza Rural Health Centre catchment, was selected for the control study arm.
The interventional study will entail a high-input elimination study arm (E), in which multiple control options targeting both the final (human, mass drug administration, health education) and intermediate (pig) hosts (treatment and vaccination), are combined; and a lower-input control study arm (CI), which will use a single control option targeting only the porcine host (treatment).
Teams of suitably qualified and trained human and veterinary medical staff will go from door-to-door to each household in the study communities.
Procedures will include collection of both qualitative and quantitative data from human participants and pigs; subject-related interventions in both human participants and pigs; and laboratory analysis of collected samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets (the latter specific for the elimination arm)
- •Willing and able to provide informed consent (signature or thumb print with impartial witness; assent for minors with parental consent).
- •Living in, attending school in, or regularly visiting the bore holes present in, the study communities
- •Aged five years of age or older
- •People without epilepsy
排除标准
- •Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets (the latter specific for the elimination arm)
- •Unwilling or unable to provide written (signature or thumb print with impartial witness) informed consent (or assent for minors)
- •Living outside of, and not regularly visiting, or attending school in, the study communities
- •Children aged four years or younger
- •People with epilepsy (identified cases by the Rural Health Centre, questions included in the registration procedure)
- •Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses)
研究组 & 干预措施
Elimination arm
Both human and porcine interventions at four-monthly intervals in the first two study years, for a total of six iterations (only human interventions will be detailed here):
Human: Mass drug administration, praziquantel 10mg/kg, according to the list of WHO recommended anthelmintic drugs for use in preventive chemotherapy for taeniasis. And Health Education
干预措施: Mass drug administration, praziquantel 10mg/kg (Drug)
Elimination arm
Both human and porcine interventions at four-monthly intervals in the first two study years, for a total of six iterations (only human interventions will be detailed here):
Human: Mass drug administration, praziquantel 10mg/kg, according to the list of WHO recommended anthelmintic drugs for use in preventive chemotherapy for taeniasis. And Health Education
干预措施: Health education (Behavioral)
Control intervention arm
Human: yearly health education, for a total of five iterations. The intervention on the pig host will not be detailed here)
干预措施: Health education (Behavioral)
结局指标
主要结局
Change in porcine cysticercosis: in this One Health approach, the primary outcome is not a human measure
时间窗: Elimination arm: day 0, Year 1, Year 2, Year 2.5, Year 3, Year 3.5, Year 4, Year 4.5, Year 5. Control intervention arm: day 0, Year 2, Year 4,Year 5
serological measurement of porcine cysticercosis (in pigs), antigen ELISA result: ratio
次要结局
- Change in human cysticercosis active infection (serum: )(in both study arms: day 0, Year 5.)
- Change in human cysticercosis, exposure to infection (serum)(in both study arms: day 0, year 5)
- Change in human taeniasis (stool)(in both study arms: day 0, year 5; elimination study arm: Year 1, Year 2, year 2.5, year 3, year 3.5,year 4, year 4.5 and year 5)