Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095613
• Other study ID #: 2008P002017/BWH
• Secondary ID: R01HD057627
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: August 10, 2016
• Start date: May 2010
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardHaiti: Ministry for Public Health and Population
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 623
• Est. completion date: July 2016
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Food Insecurity
• HIV
• Malnutrition

Intervention

Other:
• traditional food

• food that is nutrient dense

Locations

Country	Name	City	State
Haiti	Zanmi Lasante	Marc

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Harvard Medical School, Partners in Health

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in CD4 cell count over time		6-month, 12-month	No
Primary	Change in Body Mass Index over time		6-month, 12-month	No
Secondary	Change in Quality of Life over time		6-month, 12-month	No