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Study Profile:
Nutritional Status of HIV-Positive and HIV-Negative Drug Users in Hanoi, Vietnam

Revised:

July 21, 2009

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 and Sherwood Gorbach, MD

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 consequences of poor nutritional and metabolic status on outcomes such as HIV disease progression, risk of tuberculosis (TB), death, and quality of life.

  3. 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.

  4. 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:

300 as of August 2009

Inclusion Criteria:

  1. Between the ages of 18 and 65 years
  2. Not pregnant at the time of recruitment (by self-report)
  3. Have injected heroin, opium, or other narcotics in the last 5 years
  4. 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

 

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

 

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

 

 

Data collection instruments:

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

 

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