Please select the eligibility criteria that correspond to the clinical trial below.
Title: Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression
Brief Summary: Abstract:

Over 25 million HIV-1 infected individuals are currently living in Africa and as many as 50-90% may be co-infected with soil transmitted helminths such as roundworms, hookworms or whipworms. Helminth infection in HIV-1-infected individuals may increase HIV-1 RNA levels and increase the rate of progression of HIV-1 to AIDS. Studies have also shown that successful treatment of helminth co-infection (as documented by clearance of helminth eggs in stool) led to a significant decrease in HIV-1 plasma viral load (-0.36 log10). This change in viral load was significantly greater than that seen in those individuals without documented clearance of their helminth co-infection (+0.67 log10) (p=0.04). Studies conducted in Africa have shown an estimated 2.5-fold increased risk for sexual transmission of the HIV-1 for each log increase in plasma HIV-1 viral load. In addition to direct effects on plasma viral load, the rate of CD4 cell decline in helminth infected individuals may be directly impacted by the significant immune activation seen with such co-infection.

The investigators propose a randomized controlled trial examining the potential benefits of routine empiric helminth eradication in HIV-1 infected adults who do not yet qualify for antiretroviral (ARV) therapy in Kenya. The current standard of care of symptomatic diagnosis and treatment will be compared to a systematic empiric scheduled de-worming program for HIV infected adults. The investigators will compare markers of disease progression including rate of CD4 decline and changes in HIV-1 RNA levels between the two treatment arms.


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:

Village level:

* Little existing sanitation coverage (\<10%)
* WaterAid and implementing partners expects normal scale up
* Stable and reasonably acceptable water supply
* No other WASH interventions planned or anticipated in next 30 months
* Reasonable year-round access by road to permit household visits by surveillance staff

Household level:

* Presence of a child\<4 or a pregnant woman
* Consent to participate
* Reside permanently in the village
C: Inclusion Criteria:

* Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years.

Exclusion Criteria:

* None
D: Study Population Description:

The subject population will be young children and their mothers/guardians living in several contiguous districts of Western Province, in the rural areas outside the towns of Bungoma and Kakamega. Communities must meet the following criteria:

* Located in a rural area (defined as villages with \<25% residents living in rental houses, \<2 gas/petrol stations and \<10 shops)
* Not enrolled in ongoing WASH or nutrition programs
* No chlorine dispensers at water sources installed by programs separate from the present study
* Majority (\>80%) of households do not have access to piped water into the home
* At least six eligible pregnant women in the cluster at baseline.

From enrolled communities, household compounds will be enrolled if they meet the following criteria.

Inclusion Criteria:

1. One or more women who self-identify as pregnant at the time of the baseline survey
2. The woman plans to stay in the community for the next 12 months.

Exclusion Criteria:

(1) The study excludes households who do not own their home to help mitigate attrition during follow-up.

Answer: A