Please select the eligibility criteria that correspond to the clinical trial below.
Title: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project
Brief Summary: Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.


Options:
A: Treatment Inclusion Criteria:

* Ages 12 months and older

Treatment Exclusion Criteria:

* Children under 12 months of age
* Pregnant women in their first trimester
* History of adverse reaction to benzimidazoles

Outcome Sampling Inclusion Criteria:

* Resident of study clusters
* Ages 12 months and older
* Willingness of adult aged 18 years and above (or age as per country specific ethical guidelines) or parent/guardian of child to provide written informed consent
* Provision of written assent to participate from children aged 8 years and above (or age as per country specific ethical guidelines)

Outcome Sampling Exclusion Criteria:

* Less than 12 months of age
* Individuals who do not typically reside in the study cluster
* Nonconsenting or assenting individuals, as applicable
B: Inclusion Criteria:

* Deliver at Hospital Iquitos
* Plan to reside in Iquitos or neighbouring area for the next 24 months
* Able to communicate in Spanish

Exclusion Criteria:

* Deliver multiples
* Delivery a stillborn or an infant with a serious congenital medical condition
* Transfered to another hospital prior to discharge
C: Inclusion Criteria:

* Pregnant women with severe anemia (Hb\<70g/L)
* Children 6-24 months with severe anemia (Hb\<70 g/L)

Exclusion Criteria:

* Gestational age \>=36 weeks
* Edema
* Breathlessness
D: Inclusion Criteria:

For screening:

* Female, age 18 or over.
* Present to a study midwife with suspected pregnancy.
* Live in a study village.

For the main study:

* Infected with S. japonicum.
* Pregnancy as determined by urine pregnancy test.
* Age 18 or older.
* Participant is otherwise healthy as determined by history, physical exam, ultrasound and laboratory assessment.
* Pregnancy between 12-16 weeks gestation.
* Ability to provide informed consent to participate.

Exclusion Criteria:

* Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound and laboratory assessment. In particular:

  1. History of seizures or other neurologic disorder, chronic medical problem determined by history or physical examination, e.g. active hepatitis, tuberculosis, heart disease.
  2. Grade 3 or higher laboratory abnormality of blood urea nitrogen (BUN), Creatinine, bilirubin, white blood cell count, or platelet count will warrant exclusion. Grade 2 or higher abnormality of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will warrant exclusion. For hemoglobin, women with severe anemia defined as hemoglobin less than 7.0 g/dl will be excluded.
  3. Women with myoma on ultrasound that are sub-mucosal or women with myoma that is in any location and greater than 5 cm in size.
  4. Women with congenital anomalies of the reproductive tract that would be expected to cause decreased fetal weight or greatly increase the risk of prematurity such as duplicate uterus, uterine septum.
  5. For less clear cases, the researchers will define significant illness as one that significantly alters a woman's ability to perform activities of daily living, causes symptoms at least two days per week, or necessitates regular use of medication. In the case of acute medical conditions such as urinary tract infection, pneumonia, febrile illness, enrollment may be postponed until the illness is successfully treated (not currently on any medication for the illness) or the illness self resolves if this occurs before 16 weeks gestation.
* Presence of cysts in the eye suggestive of neurocysticercosis.
* Regular use of a medication for a chronic medical condition.
* History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration.
* Fetus has congenital anomaly determined by 12-16 week ultrasound or is determined to be nonviable (e.g. blighted ovum).
* Twin or higher order pregnancy.
* Woman has been enrolled into this study for a previous pregnancy.
* Inability to comprehend study procedures and provide informed consent due to limited cognitive abilities or other, or refuses to provide informed consent.

Answer: A