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Study Profile:
A Survey of the Nutritional Status of HIV-Positive and HIV-Negative Persons Who Use Recreational Drugs: A Three-City Study (TNC Study)

Revised:

February 21, 2008

Study Sites:

Tufts University School of Medicine, Boston, MA
Brown University, Providence, RI
Johns Hopkins University School of Medicine, Baltimore, MD

Study Name:

A Survey of the Nutritional Status of HIV-Positive and HIV-Negative Persons Who Use Recreational Drugs: A Three-City Study (TNC Study)

Study Status:

Data analysis only

Principal Investigator:

Alice Tang, PhD

Years of Funding:

2002-2007

Study Design:

Longitudinal Study

Study Aims:

  1. To characterize and compare the nutritional and metabolic status and food intake patterns of several ethnically diverse cohorts of male and female drug users (DUs) with and without HIV-1 infection. Specifically, HIV seropositive and negative African-American DUs from Baltimore (Johns Hopkins), Hispanic DUs from Boston (Tufts), and Caucasian DUs from Providence (Brown) will comprise the study population.
  2. To determine and compare the prevalence and incidence of HIV-related weight loss, obesity, morphologic abnormalities (i.e. peripheral lipoatrophy and/or visceral adiposity) and metabolic abnormalities (hypertriglyceridemia, insulin resistance) in ethnically diverse male and female drug users living in three US cities (Baltimore, Boston, Providence).
  3. To determine how differences in ethnicity, geography, and environment (e.g. types and frequency of illicit drugs used, access to health care and medications, medication adherence, socioeconomic status, demographics, dietary intake, alcohol intake, quality of life, etc.) as well as HIV disease progression and co-infections may play a role in the etiology of these syndromes.

Study or Clinic Location

Tufts Medical Center, Boston, MA
The Miriam Hospital, Providence, RI
Johns Hopkins School of Medicine, Baltimore, MD

# of Participants:

Goal:

600 (200 participants at each site- 50% HIV-Positive, 50% HIV-Negative)

Actual data:

158= Boston
149 = Providence
211 = Baltimore

Inclusion Criteria:

Participants are eligible if they are enrolled in one of the parent studies at each site and meet the following eligibility criteria:

  1. Participant is between the ages of 18 and 65 years.
  2. Participant is not pregnant at the time of recruitment (by self-report).
  3. Participant has used heroin, crack, cocaine, poppers, or amphetamines (either injected, smoked, or snorted) ever in the past 5 years.
  4. Subject understands the study, agrees to procedures, and signs the consent form.

Definition of Drug Use

Participant has used heroin, crack, cocaine, poppers, or amphetamines (either injected, smoked, or snorted) ever in the past 5 years.

Participant Characteristics:

% Female:

35%

% HIV+

54%

% DU (IDU or non-IDU)

IDU – 28.3%
Non-IDU – 71.7%

% IVDU

Total:  109       72.5 % Male    27.5 % Female

% non-IVDU

Total: 278        62.2 % Male     37.8 % 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

X

 

 

Fasting glucose/insulin

X

 

 

C-reactive protein (CRP)

X

 

 

Ferritin

X

 

 

Data collection instruments:

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

 

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