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OpenTrials
Completed

NCT Number: NCT02095613

Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

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.

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Key information

Conditions

HIV Food Insecurity Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zanmi Lasante

Marc, Haiti

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traditional food

Other

food that is nutrient dense

Other

Primary outcomes

  1. Change in Body Mass Index over time

    Time frame: 6-month, 12-month

Secondary outcomes

  1. Change in Quality of Life over time

    Time frame: 6-month, 12-month

Other outcomes

  1. Change in CD4 cell count over time

    Time frame: 6-month, 12-month

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Harvard Medical School (HMS and HSDM)
  • Partners in Health

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2016
First posted
Mar 26, 2014
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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