Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Harvard Medical School
Partners In Health
Information provided by (Responsible Party):
Louise Ivers, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT02095613
First received: March 20, 2014
Last updated: March 21, 2014
Last verified: March 2014
  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: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Haiti
Zanmi Lasante
Marc, Haiti
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Medical School
Partners In Health
Investigators
Principal Investigator: Louise Ivers, MB, BCh, BAO Brigham and Women's Hospital
  More Information

No publications provided

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:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 24, 2014