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

Revised:

October 12, 2006

Study Site:

Tufts University School of Medicine

Study Name:

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

Study Status:

Data analysis only

Principal Investigator:

Janet Forrester

Years of Funding:

1999-2003; 2004-2008

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 recruit 3 groups, to be followed over 3 years with twice-yearly visits: Hispanic HIV-positive drug abusers (Group 1), Hispanic HIV- positive persons who are not drug abusers (Group 2), Hispanic HIV- negative drug abusers (Group 3).
  2. To assess nutritional status by measures of height, weight, serum albumin, serum vitamins A, B12, and E, and selenium and zinc.
  3. To determine body composition (lean body mass and body fat) by measures of skinfold thickness and bioelectrical impedance analysis.
  4. To measure dietary intake of calories and nutrients with a food frequency questionnaire, a 24-hour dietary recall, and a 3-day food record.
  5. To assess gastrointestinal function by D-xylose absorption.
  6. To measure total energy expenditure by indirect calorimetry and physical activity measures.
  7. 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:

300

Actual participants:

300

Inclusion Criteria:

  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. Screened for HIV status with an ELISA test.

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. Diabetes mellitus or thyroid disease present
  5. Pregnant at time of recruitment
  6. Informed consent not granted

Definition of Drug Use

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

Participant Characteristics:

% Female:

29.6%

% HIV+

54.7%

% DU (IDU or non-IDU)

43.8%

Study Domains:

 

6 mos.

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:
Socio-demographic information
Medical history, medications
Quality of life, depression
Recreational drug use

X

 

 

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 (baseline only)

 

 

 

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

Data collection instruments:

  • Screening Questionnaire
  • Clinical Status Questionnaire
  • Food frequency questionnaire, 3-day food record, 24-hour recall
  • Physical activity recall

 

 

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