Please select the eligibility criteria that correspond to the clinical trial below.
Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine
Brief Summary: In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..


Options:
A: Inclusion Criteria:

* Permanent or temporary resident of study Shehias (i.e., persons who stayed in the selected household the night before the interview)
* Provision of informed consent (refusal must be recorded)
* Age \>6 months

Exclusion Criteria:

* Women pregnant in first trimester (assessed by a specific set of questions designed to exclude pregnancy)
* Severe disease that requires immediate referral to health facility or hospital
* Concurrent antimalarial treatment at time of MDA or during the last 14 days
* Inability to take oral medication

Additional exclusion criteria for treatment with SLD Primaquine:

* Pregnancy (all trimesters, assessed by a specific set of questions designed to exclude pregnancy)
* Women breast feeding infants aged \< 6months
B: Inclusion Criteria:

* permanent resident of the research area
* age \>1 years

Exclusion Criteria:

* severe anemia
* pregnancy
C: Inclusion Criteria:

* Individuals who consent to participate in the study
* Residents in the study area
* Older than 6 months of age (or weighing more than 5Kg)
* Women in the second or third trimester who are not on IPTp

Exclusion Criteria:

* Individuals who do not consent to participate in the study
* Younger than 6 months of age (or weighing more than 5Kg)
* Women in the first trimester of pregnancy
* Severely ill individuals
* Individuals on contra-indicated medication
D: Inclusion Criteria:

* anyone not excluded and consenting

Exclusion Criteria:

* contraindications from manufacturer for medications including currently taking haloperidol, artane, Phenergan (Promethazine), chlorpromazine, erythromycin, Azithromycin, clarithromycin, Ketoconazole, fluconazole, mefloquine (as prophylaxis), lumefantrine (in Coartem), quinine, Septrin
* anyone seriously ill
* currently taking antimalarial medicines
* allergy to artemisinin drugs
* pregnant women in first trimester
* children under 3 months of age
* reported heart condition

Answer: B