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Study Profile:
Nutritional Status of HIV-Positive and HIV-Negative Drug Users in Buenos Aires, Argentina

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:

  1. 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.
  2. To determine the effects of HIV, co-morbidities, and drug use on the prevalence and incidence of nutritional and metabolic abnormalities.
  3. 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:

  1. Participant is between the ages of 18 and 65.
  2. Participant has injected, smoked, or snorted cocaine or coca paste in the past 5 years.
  3. Female participants are not pregnant at the time of recruitment (by self-report).
  4. 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

 

Anthropometrics/Body Composition:

 

Height, weight, skinfolds

X

 

 

Waist/Hip Circumference

X

 

 

Bioelectrical Impedence (BIA)

X

 

 

 

 

Dietary Intake:

 

24 hr recall

X

 

 

Clinical Status Questionnaire:
Demographic information, Health status, Quality of life, Medications, Food insecurity, Recreational Drug Use

X

 

 

 

Laboratory Tests:

 

Viral Load

X

 

 

CBC, differential, platelets

X

 

 

T-cell subsets

X

 

 

Chemistry: albumin

X

 

 

Micronutrients (Zn, Sel, A, E)

X

 

 

Lipids

X

 

 

Hep B, Hep C (baseline only)

X

 

Fasting glucose/insulin

X

 

 

C-reactive protein (CRP)

X

 

 

Data collection instruments:

  • Screening Questionnaire
  • Lifestyle Questionnaire
  • 24-hour recall forms
  • Physical Exam form
  • Anthropometric form
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