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Study Profile:
Nutritional Status of HIV-positive Hispanic Drug Abusers (BIENESTAR)

Revised:

October 12, 2006

Study Site:

Tufts University School of Medicine

Study Name:

Nutritional Status of HIV-positive Hispanic Drug Abusers (BIENESTAR)

Study Status:

Data analysis only

Principal Investigator:

Janet Forrester

Years of Funding:

1998-2003

Study Design:

A prospective cohort comprised of 3 Groups:

  1. 100 Hispanic HIV-positive drug abusers
  2. 100 Hispanic HIV-positive people who are not drug abusers
  3. 100 Hispanic HIV-negative drug abusers

Study Aims:

  1. To assess nutritional status by measures of height, weight, serum albumin
  2. To determine body composition (lean body mass and body fat) by measures of skinfold thickness and bioelectrical impedance analysis.
  3. To measure dietary intake of calories and nutrients with a food frequency questionnaire, a 24-hour dietary recall, and a 3-day food record.
  4. To assess gastrointestinal function by D-xylose absorption.
  5. To measure total energy expenditure by indirect calorimetry.
  6. To measure HIV infection status by plasma viral load, CD4 lymphocyte counts, functional status, quality of life measures, occurrence of infections or malignancy, and survival.

Study or Clinic Location

Tufts Medical Center GCRC

# of Participants:

Goal:

250

Inclusion Criteria:

For HIV positive drug-abusers (Group 1):

  1. Mother tongue of the subject is Spanish.
  2. Subject understands the study, agrees to procedures and follow-up visits, and signs the consent form.
  3. HIV positive by ELISA for anti-HIV antibody.
  4. Subject is a current drug abuser.

For HIV positive people who are not drug abusers (Group 2):

#1-3.

4. Subject is not a current drug abuser.

For HIV negative drug abusers (Group 3):

#1-2.

  1. 3HIV negative by ELISA for anti-HIV antibody.
  2. Subject is a current drug abuser.

Exclusion Criteria:

  1. Less than 18 years of age
  2. Spanish not first language
  3. Cancer present (other than HIV-associated cancers or non-melanoma skin cancer)
  4. Pregnant at time of recruitment
  5. Informed consent not granted

Definition of Drug Use

A drug user in this study is defined as anyone who reports having used heroin, cocaine, methadone, or amphetamines at least once in the previous 6 months.

Participant Characteristics:

% Female:

23%

% HIV+

57%

% DU (IDU or non-IDU)

88%

Study Domains:

(At Entry and)

Every 6 mos.

Every 12 mos.

 

Anthropometry:

 

Height, weight, skinfolds

X

 

 

Bioelectrical Impedance

X

 

 

Hand grip strength

X

 

 

Dietary Intake:

 

Food frequency questionnaire

X

 

 

24-hour recall + 3-day food record

X

 

 

Clinical Status Questionnaire:

X

 

 

Socio-demographic information

 

 

 

Medical history, medication history

 

 

 

Quality of life, depression

 

 

 

Recreational drug use

 

 

 

Energy expenditure:

 

Indirect calorimetry (REE)

X

 

Physical activity recall

X

 

Gastrointestinal function:

 

D-xylose absorption test

X

 

Laboratory Tests:

 

Viral load

X

 

CBC, differential, platelets

X

 

T-cell subsets

X

 

Chemistry

X

 

Vitamins A, B12, E, selenium and zinc*

 

HIV ELISA**

 

* Baseline only
**Baseline only except in HIV-negative group, in whom it is repeated every 6 months

Data collection instruments:

  1. Clinical Status Questionnaire
  2. Food frequency questionnaire, 3-day food record, 24-hour recall
  3. Physical activity recall

 

 

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