|
Revised: |
February 21, 2008 |
Study Site: |
National Institute of Infectious and Tropical Diseases (NIITD) in Hanoi, Vietnam |
Study Name: |
Nutritional Status of HIV-Positive and HIV-Negative Drug Users in Hanoi, Vietnam |
Study Status: |
Enrolling subjects |
Principal Investigator: |
Alice Tang, PhD |
Years of Funding: |
2005-2011 |
Study Design: |
Longitudinal Study |
Study Aims: |
- To characterize HIV-positive and HIV-negative IDUs in terms of: a) types, frequency and patterns of drug use, b) co-morbidities, and c) nutritional and metabolic abnormalities.
- To determine the consequences of poor nutritional and metabolic status on outcomes such as HIV disease progression, risk of tuberculosis (TB), death, and quality of life.
- To determine the proportion of individuals with detectable HIV drug resistance to drugs in the national standard first-line HAART regimen prior to starting the first-line regimen; and to conduct phylogenetic analyses to determine the HIV subtypes circulating in infected drug users.
- To determine the effects of HIV (including subtypes), co-morbidities, and drug use on the prevalence and incidence of nutritional and metabolic abnormalities.
|
Study or Clinic Location |
National Institute of Infectious and Tropical Diseases (NIITD) in Hanoi, Vietnam |
# of Participants: |
Goal: |
300 (200 HIV-positive and 100 HIV-negative) |
Actual data: |
133 as of 1/08 |
Inclusion Criteria: |
- Between the ages of 18 and 65 years
- Not pregnant at the time of recruitment (by self-report)
- Have injected heroin, opium, or other narcotics in the last 5 years
- Understand the study, agree to the procedures, and sign the consent form
|
Definition of Drug Use |
Have injected heroin, opium, or other narcotics in the last 5 years |
Participant Characteristics: |
% Female: |
0% |
% HIV+ |
100% |
% DU (IDU or non-IDU) |
49% |
% IVDU |
Total: 22% Male 22% Female 0% |
% non-IVDU |
Total: 27% Male 27% Female 0% |
Study Domains: |
(At Entry and) |
Every 6 Months |
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Anthropometrics/Body Composition: |
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Height, weight, skinfolds |
X |
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Waist/Hip Circumference |
X |
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Bioelectrical Impedence (BIA) |
X |
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Dietary Intake: |
|
24 hr recall |
X |
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Clinical Status Questionnaire:
Demographic information,
Health status, Quality of life, Medications, Food insecurity, Recreational Drug Use |
X
X |
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Laboratory Tests: |
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Viral Load |
X |
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CBC, differential, platelets |
X |
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T-cell subsets |
X |
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Chemistry: albumin |
X |
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Micronutrients (Zn, Sel, A, E) |
X |
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Lipids |
X |
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Hep B, Hep C (baseline only) |
X |
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Fasting glucose/insulin |
X |
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Data collection instruments: |
- Screening Questionnaire
- Lifestyle Questionnaire
- 24-hour recall forms
- Physical Exam form
- Anthropometric form
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