Please select the eligibility criteria that correspond to the clinical trial below.
Title: Design and Clinical Evaluation of a School Meal With Deworming Properties
Brief Summary: Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to IPs is greatest in school-age children who typically have the highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of antihelminthic drugs to deworm children in developing countries. Though initially effective, there is concern that MDA might not be sustainable over extended periods especially considering the large children populations and the high frequency of dosing. Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for alternatives that are not only affordable and sustainable but easier to implement in the long term with a minimal chance of development of resistance. The investigators propose to develop and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that have been shown to have antihelminthic properties. The investigators intend to evaluate its efficacy when given through school feeding programs and compare the outcome with albendazole- the recommended MDA agent for deworming school children. The investigators will design and formulate the product and test it among children in three primary schools in Western Kenya.


Options:
A: Inclusion Criteria:

* Participants must not be or have been on highly active antiretroviral therapy.
* Participants must have CD4 count \> 350 cells/mm3 in order to be enrolled in the randomized controlled trial.
* Participants must be at least 18 years of age.
* Participants must be able and willing to participate and give written informed consent.
* Participants must be able and willing to return for the scheduled follow-up visits.

Exclusion Criteria:

• Participants must not be pregnant at the time of enrollment (by urine HCG testing).
B: Inclusion Criteria:

* Consenting parents and guardians

Exclusion Criteria:

* children with known allergy to papaya fruit products
C: Inclusion Criteria:

* Participants must not be or have been on highly active antiretroviral therapy.
* Participants must have a CD4 count greater than 250 cells/mm3.
* Participants must be at least 18 years of age.
* Participants must be able and willing to participate and give written informed consent.
* Participants must be able and willing to return for the scheduled follow-up visits.
* In addition, in order to be included in the treatment phase of the study, patients must have at least one stool specimen positive for a soil transmitted helminth.

Exclusion Criteria:

* Participants who have received treatment for helminth infection in the past 6 months (by self report or chart review).
* Participants must not be pregnant at the time of treatment (by urine HCG testing).
* Participants who present with other serious co-morbidities such as severe anaemia, malaria or tuberculosis.
D: Exclusion Criteria:

* Subjects who are unable to provide a stool sample at follow-up
* Subjects who are experiencing a severe concurrent medical condition
* Subjects with diarrhea at first sampling

Answer: B