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Study Profile:
Nutritional Status of HIV-Positive and HIV-Negative Injecting Drug Users (IDUs) in Chennai, India

Revised:

July 21, 2009

Study Site:

Chennai, the capital of Tamil Nadu in South India

Study Name:

Nutritional Status of HIV-positive and HIV-negative injecting drug users (IDUs) in Chennai, India

Study Status:

Enrolling

Principal Investigator:

Sherwood Gorbach, MD and Alice Tang, PhD

Years of Funding:

2005-2011

Study Design:

  Longitudinal Study

Study Aims:

  1. 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.

  2. To determine the effects of HIV (including subtypes), co-morbidities, and drug use on the prevalence and incidence of nutritional and metabolic abnormalities.

  3. 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

Study or Clinic Location

HOPERS Foundation community health center in Chennai

# of Participants:

Goal:

200 (100 HIV-positive and 100 HIV-negative)

Actual data:

150 enrolled

Inclusion Criteria:

  1. Men between the ages of 18 and 65 years
  2. Have injected heroin, opium, or other narcotics in the last 5 years
  3. 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+

36%

% DU (IDU or non-IDU)

Data not yet available

% IVDU

Total:        % Male        % Female

% non-IVDU

Total:        % Male        % 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:

HVC/Hep B (baseline only)

X

 

Viral Load

X

 

 

CBC, differential, platelets

X

 

 

T-cell subsets

X

 

 

Chemistry: albumin

X

 

 

Micronutrients (Zn, Sel, A, E)

X

 

 

Lipids

X

 

 

 

 

Fasting glucose/insulin

X

 

 

C-reactive protein (CRP)

X

 

 

Liver function tests

X

 

 

Data collection instruments:

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

 

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