Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Impact of Different Treatment Strategies on the Transmission Dynamics of Soil-transmitted Helminths: a Cluster Randomised Trial in Kenya
Brief Summary: The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but recent modelling has highlights that in all but low very transmission settings, the treatment of school-aged children is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH and if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? In this study, two paired community cluster randomised trials in different settings in Kenya will evaluate the impact and cost-effectiveness of annual school-based deworming, annual community-based deworming, and biannual community-based deworming. The interventions are (i) annual mass anthelmintic treatment delivered either to pre-school and school-aged children, as part of a national school-based deworming programme, or to the entire community delivered by community health workers. The primary outcome measure is the prevalence of hookworm infection (the most common STH species), assessed by periodic cross-sectional, age-stratified parasitological surveys. Secondary outcomes include intensity of hookworm, prevalence and intensity of Ascaris lumbricoides, treatment coverage, and among a randomly selected sub-sample of participants who will be followed longitudinally, worm burden and proportion of eggs unfertilised. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis will investigate the community acceptability, feasibility given the local and regional health system structures and processes, and scale-up of the interventions.


Options:
A: Inclusion Criteria:

* presence of intestinal helminths eggs in the stool

Exclusion Criteria:

* allergy to imidazole derivate
* No intestinal helminths
B: Inclusion Criteria:

* Subject, male or female, is 5-14 years of age
* Subject is otherwise in an healthy condition (medical history and physical examination)
* Parent(s)/guardians of subjects (or their legally-accepted representatives) signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study.
* Subject of ≥6 years has assented (agreed) to participate in the study.
* Subject of ≥12 has signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
* The subject swallowed the entire drug (ALB 400 mg) under supervision
* Subject provides a stool sample of at least 9 grams

Exclusion Criteria:

* Subject has active diarrhea (defined as the passage of 3 or more loose or liquid stools per day) at baseline or follow-up
* Subject has any acute medical condition or is experiencing a severe concurrent medical condition
* Subject has a known hypersensitivity to benzimidazole drugs
* Subject has received an anthelminthic treatment within 90 of the start of the treatment.
* Subject vomited within 4 hours after drug administration
* Subject is unable to provide a stool sample at follow-up
C: Inclusion Criteria:

* Age 7-12 years (according to birth date in birth certificate).
* No evidence of concomitant severe and/or chronic illness such as acute respiratory tract infections, mental retardation and neurological deficits.
* Consent of parent to participate in the study.

Exclusion Criteria:

* history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
* menstruating females (age \>13)
D: Inclusion Criteria:

* Usual resident of study community or student enrolled in study school;
* Willingness of adult aged 18 years and above or parent/guardian to provide written informed consent;
* Provision of written assent to participate from children aged 8 years and above.

Exclusion Criteria:

* Visitor to household at time of household visits;
* Refusal of informed consent;
* Refusal to assent by children aged 8 years and above.

Answer: D