Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

Mass General Brigham

Status: Completed

Conditions: Malnutrition; HIV; Food Insecurity

Treatments: Other: food that is nutrient dense; Other: traditional food

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02095613

R01HD057627 (U.S. NIH Grant/Contract)

2008P002017/BWH

Details and patient eligibility

About

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.

Enrollment: 623 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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623 participants in 2 patient groups

Corn-soy-blend plus

Active Comparator group

Description:

food A type of ground meal called corn-soy-blend plus

Treatment:

Other: traditional food

Ready-to-use-supplementary food

Active Comparator group

Description:

food A nutrient dense food comprised of peanuts, oil, multivitamins.

Treatment:

Other: food that is nutrient dense