Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

N/ACompletedNCT02095613

Brigham and Women's Hospital623 enrolled

Overview

The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

623

Conditions

HIV Food Insecurity Malnutrition

Interventions

traditional foodOTHER

food that is nutrient denseOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * documented to have HIV infection by standard laboratory procedures * live in the geographic catchment area of PIH services where study is taking place * 18 years of age or older * started antiretroviral therapy for HIV in the 24 months prior to study enrollment Exclusion Criteria: * if another household member is also eligible for food assistance * if subject is pregnant at the time of enrollment * if unable to give informed consent

Locations (1)

Zanmi Lasante

Marc, Haiti

Outcomes

Primary Outcomes

Change in Body Mass Index over time

Time frame: 6-month, 12-month

Secondary Outcomes

Change in Quality of Life over time

Time frame: 6-month, 12-month

Data from ClinicalTrials.gov

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