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Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02095613
First Posted: March 26, 2014
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Harvard Medical School
Partners in Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Louise Ivers, MD, Brigham and Women's Hospital
  Purpose
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.

Condition Intervention
HIV Food Insecurity Malnutrition Other: traditional food Other: food that is nutrient dense

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Louise Ivers, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in Body Mass Index over time [ Time Frame: 6-month, 12-month ]

Secondary Outcome Measures:
  • Change in Quality of Life over time [ Time Frame: 6-month, 12-month ]

Other Outcome Measures:
  • Change in CD4 cell count over time [ Time Frame: 6-month, 12-month ]

Enrollment: 623
Study Start Date: May 2010
Study Completion Date: July 2016
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095613


Locations
Haiti
Zanmi Lasante
Marc, Haiti
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Medical School
Partners in Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Louise Ivers, MB, BCh, BAO Brigham and Women's Hospital
  More Information

Responsible Party: Louise Ivers, MD, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02095613     History of Changes
Other Study ID Numbers: 2008P002017/BWH
R01HD057627 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2014
First Posted: March 26, 2014
Last Update Posted: August 11, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders