HIV Infections Clinical Trial
— ITNOfficial 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
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Kenya | Kisii Provincial Hospital | Kisii | |
Kenya | Kisumu District Hospital, UW/KEMRI Research Clinic | Kisumu |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Kenya Medical Research Institute |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the effect of LLIN and a simple microbiological water purification system on markers of HIV progression (time to HAART eligibility and changes in CD4 counts) among antiretroviral naïve, HIV infected adults in Kenya. | PRIMARY AIM (Aim 1): To determine the effect of the intervention, we will evaluate the effect of the provision of LLIN and water filters on markers of disease progression at 12 months. We will compare the time to eligibility for ART between the groups and the time to CD4 counts of less than 200 and 350 respectively using Cox regression analysis models. In addition, we will compare differences between the mean change in CD4 counts at month 12 of follow-up using ANCOVA controlling for baseline CD4 values. | Mass screening and enrollment in July 2009, followed by two years of follow-up, and up to a year of data analysis. | No |
Secondary | 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 among antiretroviral naïve, HIV infected adults in Kenya. | Aim 2: To determine the effect of the intervention on the incidence of diarrheal disease and malaria parasitemia, we will compare the frequency of reported diarrheal illness and documented parasitemia between the intervention and comparison groups using poisson regression or generalized estimating equation model. | Same as primary outcome. | No |
Secondary | To determine the durability of provision of an LLIN and a simple microbiological water purification system on markers of disease progression up to 24 months among antiretroviral naïve, HIV infected adults in Kenya. | Aim 3: To determine the durability of the intervention, we will evaluate the effect of the provision of LLIN and water filters on markers of disease progression up to 24 months. We will compare the time to eligibility for ART between the groups and the time to CD4 counts of less than 200 and 350 respectively using Cox regression analysis models. In addition, we will compare changes in mean CD4 counts overtime between the groups using linear mixed effects models controlling for baseline values. | Same as primary outcome | No |
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