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Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya (ITN)
This study is not yet open for participant recruitment.
Verified by University of Washington, June 2009
First Received: June 2, 2009   Last Updated: July 8, 2009   History of Changes
Sponsors and Collaborators: University of Washington
Kenya Medical Research Institute
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00914225
  Purpose

In many areas of the world most severely affected by the HIV/AIDS pandemic, insect and water-borne diseases such as malaria and diarrheal disease are common causes of illness and death. In addition, diarrhea and malaria are more common and more severe among adults and children infected with HIV. These infections may modulate the immune system, affect the replication of the HIV virus and could result in more rapid HIV disease progression in co-infected individuals. Access to practical, inexpensive and easy to use interventions to prevent these diseases may be effective in delaying HIV progression.

Current Kenya government and World Health Organization guidelines recommend the use of cotrimoxazole (trimethoprim-sulfamethoxazole [TMP/SMX]) to prevent co-infections, including malaria. Despite the provision of TMP/SMX to HIV-infected adults, infections with malaria and pathogens causing diarrhea remain common causes of morbidity and mortality in many resource-limited settings. In addition, TMP/SMX may not prevent all infections with malaria or other pathogens due to alternative mechanisms of action, antimicrobial resistance and non-compliance due to adverse events or other reasons.

We propose a study to evaluate the impact of providing insecticide treated bednets and a simple water filtration device on markers of HIV disease progression among a cohort of ART naïve, HIV infected adults prescribed TMP/SMX in Kenya. In addition, we propose to evaluate the effect of these interventions on malaria and diarrheal disease incidence and on compliance with TMP/SMX.


Condition Intervention
HIV Infections
Human Immunodeficiency Virus
Malaria
Plasmodium Falciparum
Diarrhea
Other: Bednets and Water Purification

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Effect of Long-Lasting Insecticide-Treated Bednets and a Point-of-Use Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • To determine the effect of LLIN and a simple microbiological water purification system on markers of HIV progression (time to HAART eligibility, changes in CD4 counts, WHO Clinical Staging and mortality). [ Time Frame: Mass screening and enrollment in July 2009, followed by two years of follow-up, and up to a year of data analysis. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect of LLIN and a simple microbiological water purification system on the incidence of malaria and reported diarrheal disease when added to the standard regimen of TMP/SMX amongst antiretroviral naïve, HIV infected adults in Kenya. [ Time Frame: Same as primary outcome. ] [ Designated as safety issue: No ]
  • To determine the impact of LLIN and a water purification system on the health of household members of HIV infected individuals by comparing reported cases of malaria and diarrheal disease in household members. [ Time Frame: Same as primary outcome. ] [ Designated as safety issue: No ]
  • To determine adherence with TMP/SMX alone and adherence with the combination of TMP/SMX, LLIN and a water purification system, and to determine whether LLIN and the water purification system modify adherence to TMP/SMX. [ Time Frame: Same as primary outcome. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Plasma HIV RNA Plasma for Malaria PCR


Estimated Enrollment: 500
Study Start Date: July 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Bednets and Water Purification
Randomized controlled trial comparing HIV disease progression in those subjects receiving standard of care versus empiric deworming. Subjects are followed for 24 months and have serial measurements of HIV disease progression, and are evaluated serially for evidence of malaria, diarrhea and other co-morbidities. Data collected on the frequency of malaria and diarrheal disease, their use of LLIN and water filtration and their compliance with TMP/SMX.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will compare markers of HIV disease progression among ART naive individuals receiving LLIN and a simple microbiological water purification system to historical comparison group from the same clinic settings.

We are enrolling 850 HIV infected ART naïve individuals into a randomized controlled trial comparing HIV disease progression in those receiving standard of care versus empiric deworming. Subjects are followed for 24 months and have serial measurements of HIV disease progression, and are evaluated serially for evidence of malaria, diarrhea and other co-morbidities. Participants in this study will have been consented for the collection of data on the frequency of malaria and diarrheal disease, their use of LLIN and water filtration and their compliance with TMP/SMX.

Criteria

Inclusion Criteria:

  • Participants must be at least 18 years of age.
  • Participants must not be or have ever been on highly active antiretroviral therapy CD4 count at enrollment of

    • 350 cells/mm3
  • WHO Stage I or II or Stage III based on pulmonary TB only and have completed 2 months of first-line therapy.
  • 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:

  • Age less than 18 years
  • CD4 count <350 cells/mm3
  • WHO Stage III or IV HIV Disease study (unless stage III for TB and have completed 2 months of first-line therapy)
  • Participants must not be pregnant at the time of enrollment (by urine HCG testing)
  • Patients with active tuberculosis who are on second or third line therapy or have not completed at least 2 months of first line TB therapy (Participants who have completed two months of first line TB therapy will be eligible for enrolment)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914225

Contacts
Contact: Ben Piper, MEM MPH +254729048847 benpiper@u.washington.edu
Contact: Benson Singa, MBChB MPH +254725234844 singabo2008@gmail.com

Locations
Kenya
Kisumu District Hospital, UW/KEMRI Research Clinic
Kisumu, Kenya
Kisii Provincial Hospital
Kisii, Kenya
Sponsors and Collaborators
University of Washington
Kenya Medical Research Institute
Investigators
Principal Investigator: Judd T Walson, MD MPH University of Washington
Principal Investigator: Benson Singa, MBChB MPH Kenya Medical Research Institute
  More Information

No publications provided

Responsible Party: University of Washington ( Judd Walson MD MPH )
Study ID Numbers: 35464-B
Study First Received: June 2, 2009
Last Updated: July 8, 2009
ClinicalTrials.gov Identifier: NCT00914225     History of Changes
Health Authority: United States: Institutional Review Board;   Kenya: Institutional Review Board

Keywords provided by University of Washington:
Human immunodeficiency virus
malaria
plasmodium falciparum
diarrhea
helminth
HIV
Treatment naive

Study placed in the following topic categories:
Protozoan Infections
Sexually Transmitted Diseases, Viral
Diarrhea
Signs and Symptoms, Digestive
Acquired Immunodeficiency Syndrome
Disease Progression
Malaria
Immunologic Deficiency Syndromes
Virus Diseases
Signs and Symptoms
HIV Infections
Sexually Transmitted Diseases
Parasitic Diseases
Helminthiasis
Retroviridae Infections

Additional relevant MeSH terms:
Protozoan Infections
Disease Attributes
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Diarrhea
Signs and Symptoms, Digestive
Immune System Diseases
Coccidiosis
Acquired Immunodeficiency Syndrome
Disease Progression
Malaria
Infection
Immunologic Deficiency Syndromes
Virus Diseases
Signs and Symptoms
Pathologic Processes
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Parasitic Diseases
Retroviridae Infections

ClinicalTrials.gov processed this record on September 03, 2009