Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

NCT ID: NCT02095613

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

623 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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HIV Food Insecurity Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Corn-soy-blend plus

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

Group Type ACTIVE_COMPARATOR

traditional food

Intervention Type OTHER

Ready-to-use-supplementary food

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

Group Type ACTIVE_COMPARATOR

food that is nutrient dense

Intervention Type OTHER

Interventions

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traditional food

Intervention Type OTHER

food that is nutrient dense

Intervention Type OTHER

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Partners in Health

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Louise Ivers, MD

Associate Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise Ivers, MB, BCh, BAO

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Zanmi Lasante

Marc, , Haiti

Site Status

Countries

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Haiti

Other Identifiers

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R01HD057627

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008P002017/BWH

Identifier Type: -

Identifier Source: org_study_id

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