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Revised: |
February 21, 2008 |
Study Site: |
Buenos Aires, Argentina |
Study Name: |
Nutritional Status of HIV-Positive and HIV-Negative Drug Users in Buenos Aires, Argentina |
Study Status: |
Closed to enrollment - Data analysis only |
Principal Investigator: |
Sherwood Gorbach, MD |
Years of Funding: |
2005-2006 |
Study Design: |
Cross-sectional |
Study Aims: |
- To characterize HIV-positive and HIV-negative DUs in terms of: a) types, frequency and patterns of drug use, b) co-morbidities, and c) nutritional and metabolic abnormalities.
- To determine the effects of HIV, co-morbidities, and drug use on the prevalence and incidence of nutritional and metabolic abnormalities.
- To establish an infrastructure and presence in the community so that we will have populations on which to build future research studies.
|
Study or Clinic Location |
Fundacion de Ayuda Al Inmunocomprometido (FUNDAI)
Centro Nacional de Reeducacion Social (CENARESO) |
# of Participants: |
Goal: |
280 |
Actual data: |
205 enrolled, 205 compiled |
Inclusion Criteria: |
- Participant is between the ages of 18 and 65.
- Participant has injected, smoked, or snorted cocaine or coca paste in the past 5 years.
- Female participants are not pregnant at the time of recruitment (by self-report).
- Subject understands the study, agrees to procedures, and signs the consent form.
|
Definition of Drug Use |
Participant has injected, smoked, or snorted cocaine or coca paste in the past 5 years. |
Participant Characteristics: |
% Female: |
12% |
% HIV+ |
34% |
% DU (IDU or non-IDU) |
92% |
% IVDU |
Total: 10% 12% Male 0 % Female |
% non-IVDU |
Total: 82% 79% Male 96 % Female |
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: |
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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 |
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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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C-reactive protein (CRP) |
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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