Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

Not Applicable

Completed

• Conditions: Malnutrition; Food Insecurity; HIV
• Interventions: Other: traditional food; Other: food that is nutrient dense

• Registration Number: NCT02095613
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-07
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 623

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corn-soy-blend plus	traditional food	food A type of ground meal called corn-soy-blend plus
Ready-to-use-supplementary food	food that is nutrient dense	food A nutrient dense food comprised of peanuts, oil, multivitamins.

Primary Outcome Measures

Name	Time	Method
Change in Body Mass Index over time	6-month, 12-month

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life over time	6-month, 12-month

Trial Locations

Locations (1)

Zanmi Lasante; 🇭🇹 Marc, Haiti