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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 August 2016 |
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Main ID: |
NCT02095613 |
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Date of registration:
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20/03/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care
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Scientific title:
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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 |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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623 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02095613 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Haiti
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Contacts
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Name:
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Louise Ivers, MB, BCh, BAO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Food Insecurity
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HIV
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Malnutrition
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Intervention(s)
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Other: traditional food
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Other: food that is nutrient dense
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Primary Outcome(s)
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Change in Body Mass Index over time
[Time Frame: 6-month, 12-month]
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Secondary Outcome(s)
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Change in Quality of Life over time
[Time Frame: 6-month, 12-month]
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Secondary ID(s)
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R01HD057627
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2008P002017/BWH
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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