Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya (ITN)
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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: | Observational Model: Cohort Time Perspective: 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 |
- 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. [ 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 ]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.
- 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. [ Time Frame: Same as primary outcome. ] [ Designated as safety issue: No ]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.
- 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. [ Time Frame: Same as primary outcome ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Plasma HIV RNA Plasma for Malaria PCR
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Intervention
Cohort 1 is the intervention group who received long-lasting insecticide treated bednets and a water filtration device
|
Other: Bednets and Water Purification
Individuals in the intervention cohort will be provided with a LLIN and water filtration device. Subjects are followed for 24 months and have serial measurements of HIV disease progression. Data are collected every 3 months on the frequency of malaria, diarrhea and other co-morbidities, as well as compliance with LLIN and water filter use.
|
|
Comparison
Cohort 2 is the comparison group included from the control arm of the study, "Empiric therapy of helminth coinfection to reduce HIV-1 disease progression" ClinicalTrials.gov identifier: NCT00507221 As part of the RCT (NCT00507221), we have enrolled 948 HIV infected ART naïve individuals to compare 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 a bednet 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 |
The study will compare markers of HIV disease progression among ART naive individuals receiving LLIN and a simple microbiological water purification system to the control arm of the randomized controlled trial being conducted at the same clinic settings (NCT00507221).
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| Kenya | |
| Kisii Provincial Hospital | |
| Kisii, Kenya | |
| Kisumu District Hospital, UW/KEMRI Research Clinic | |
| Kisumu, Kenya | |
| 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: | Judd Walson MD MPH, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00914225 History of Changes |
| Other Study ID Numbers: | 35464-B, SSC#1554 |
| Study First Received: | June 2, 2009 |
| Last Updated: | August 16, 2011 |
| 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 |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Diarrhea Immunologic Deficiency Syndromes Malaria Disease Progression Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms Protozoan Infections Parasitic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013