NCT02095613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
623

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

March 20, 2014

Last Update Submit

August 10, 2016

Conditions

HIVFood InsecurityMalnutrition

Outcome Measures

Primary Outcomes (1)

  • Change in Body Mass Index over time

    6-month, 12-month

Secondary Outcomes (1)

  • Change in Quality of Life over time

    6-month, 12-month

Other Outcomes (1)

  • Change in CD4 cell count over time

    6-month, 12-month

Study Arms (2)

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

traditional foodOTHER
Corn-soy-blend plus
food that is nutrient denseOTHER
Ready-to-use-supplementary food

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • documented to have HIV infection by standard laboratory procedures
  • live in the geographic catchment area of PIH services where study is taking place
  • years of age or older
  • started antiretroviral therapy for HIV in the 24 months prior to study enrollment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zanmi Lasante

Marc, Haiti

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Louise Ivers, MB, BCh, BAO

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 26, 2014

Study Start

May 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2016

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

HA(1)