Tailored Nutrition and Food Security Interventions in Com... | NCT02095613

Studies
Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

NCT02095613

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Aug 11, 2016Estimated

Enrollment

623Actual

Phase

Not Applicable

Conditions

HIV
Food Insecurity
Malnutrition

Interventions

traditional food
food that is nutrient dense

Countries

Haiti

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HD057627	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2016Actual

First Submitted Date

Mar 20, 2014

First Submission Date that Met QC Criteria

Mar 21, 2014

First Posted Date

Mar 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2016

Last Update Posted Date

Aug 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Louise Ivers, MD, Associate Physician, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

623Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Corn-soy-blend plus	Active Comparator	food A type of ground meal called corn-soy-blend plus	Other: traditional food
Ready-to-use-supplementary food	Active Comparator	food A nutrient dense food comprised of peanuts, oil, multivitamins.	Other: food that is nutrient dense

Interventions

Name	Type	Description	Arm Group Labels	Other Names
traditional food	Other		Corn-soy-blend plus
food that is nutrient dense

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Body Mass Index over time		6-month, 12-month

Secondary Outcomes

Measure	Description	Time Frame
Change in Quality of Life over time		6-month, 12-month

Other Outcomes

Measure	Description	Time Frame
Change in CD4 cell count over time		6-month, 12-month

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louise Ivers, MB, BCh, BAO	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zanmi Lasante		Marc			Haiti

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided