Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2014 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
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
ClinicalTrials.gov Identifier:
First received: March 20, 2014
Last updated: March 21, 2014
Last verified: March 2014
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
Food Insecurity
Other: traditional food
Other: food that is nutrient dense

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in Body Mass Index over time [ Time Frame: 6-month, 12-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Quality of Life over time [ Time Frame: 6-month, 12-month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in CD4 cell count over time [ Time Frame: 6-month, 12-month ] [ Designated as safety issue: No ]

Enrollment: 623
Study Start Date: May 2010
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02095613

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)
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 
Study First Received: March 20, 2014
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board
Haiti: Ministry for Public Health and Population

Additional relevant MeSH terms:
Nutrition Disorders

ClinicalTrials.gov processed this record on May 26, 2016