Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

August 10, 2016 updated by: Louise Ivers, MD, Brigham and Women's Hospital

A Randomized Trial of Ready-to-use-supplementary Food Compared to Corn-soy-blend+ as Food Rations for HIV-infected Adults on Antiretroviral Therapy in Rural Haiti

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

623

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Haiti
      • Marc, Haiti
        • Zanmi Lasante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corn-soy-blend plus
food A type of ground meal called corn-soy-blend plus
Other: traditional food
Active Comparator: Ready-to-use-supplementary food
food A nutrient dense food comprised of peanuts, oil, multivitamins.
Other: food that is nutrient dense

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Body Mass Index over time
Time Frame: 6-month, 12-month
6-month, 12-month

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Quality of Life over time
Time Frame: 6-month, 12-month
6-month, 12-month

Other Outcome Measures

Outcome Measure
Time Frame
Change in CD4 cell count over time
Time Frame: 6-month, 12-month
6-month, 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Harvard Medical School (HMS and HSDM)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Partners in Health

Investigators

  • Principal Investigator: Louise Ivers, MB, BCh, BAO, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008P002017/BWH
  • R01HD057627 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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