Back to resultsTailored Nutrition and Food Security Interventions in Comprehensive HIV Care
Primary Purpose
HIV, Food Insecurity, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Haiti
Study Type
Interventional
Intervention
traditional food
food that is nutrient dense
Sponsored by
About this trial
This is an interventional supportive care trial for HIV
Eligibility 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
Sites / Locations
- Zanmi Lasante
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Corn-soy-blend plus
Ready-to-use-supplementary food
Arm Description
food A type of ground meal called corn-soy-blend plus
food A nutrient dense food comprised of peanuts, oil, multivitamins.
Outcomes
Primary Outcome Measures
Change in Body Mass Index over time
Secondary Outcome Measures
Change in Quality of Life over time
Full Information
NCT ID
NCT02095613
First Posted
March 20, 2014
Last Updated
August 10, 2016
Sponsor
Brigham and Women's Hospital
Collaborators
Harvard Medical School (HMS and HSDM), Partners in Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT02095613
Brief Title
Tailored Nutrition and Food Security Interventions in Comprehensive HIV 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Harvard Medical School (HMS and HSDM), Partners in Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Food Insecurity, Malnutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
623 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corn-soy-blend plus
Arm Type
Active Comparator
Arm Description
food A type of ground meal called corn-soy-blend plus
Arm Title
Ready-to-use-supplementary food
Arm Type
Active Comparator
Arm Description
food A nutrient dense food comprised of peanuts, oil, multivitamins.
Intervention Type
Other
Intervention Name(s)
traditional food
Intervention Type
Other
Intervention Name(s)
food that is nutrient dense
Primary Outcome Measure Information:
Title
Change in Body Mass Index over time
Time Frame
6-month, 12-month
Secondary Outcome Measure Information:
Title
Change in Quality of Life over time
Time Frame
6-month, 12-month
Other Pre-specified Outcome Measures:
Title
Change in CD4 cell count over time
Time Frame
6-month, 12-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Ivers, MB, BCh, BAO
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zanmi Lasante
City
Marc
Country
Haiti
12. IPD Sharing Statement
Learn more about this trial
Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care
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