Food Insecurity, HIV, Malnutrition
Conditions
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.
Interventions
OTHERtraditional food
OTHERfood that is nutrient dense
Sponsors
Harvard Medical School (HMS and HSDM)
Partners in Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Body Mass Index over time | 6-month, 12-month |
Secondary
| Measure | Time frame |
|---|---|
| Change in Quality of Life over time | 6-month, 12-month |
Other
| Measure | Time frame |
|---|---|
| Change in CD4 cell count over time | 6-month, 12-month |
Countries
Haiti
Outcome results
None listed