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Improving Food Security and Nutrition to Promote ART Adherence in Latin America

NCT01191281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2012-10-18

No results posted yet for this study

Summary

The purpose of this three-year study is to develop, implement, and pilot test a culturally appropriate, multi-component nutrition intervention for people living with HIV and food insecurity in Honduras, which is among the Latin America nations with the highest HIV prevalence rates. The investigators specific aims are to:

1. Explore the relationships between food security, nutrition, and HIV treatment access, utilization, and adherence, and examine key mediators and moderators of these relationships.
2. Develop a multi-component nutrition intervention to address food insecurity among Honduran HIV+ individuals and their families.
3. Evaluate the preliminary effectiveness of the intervention on (1) food security and nutritional status; (2) HIV care retention (clinic attendance), uptake of ART when recommended, and ART adherence; and (3) clinical outcomes (CD4 count, ART side effects, and opportunistic infections).
4. Examine key mediators and moderators of the intervention effects from among characteristics of the patient, household, and contextual setting.

Conditions

  • Medication Adherence

Interventions

BEHAVIORAL

Diet/nutrition counsel+food aid

Patients enrolled in the experimental arm will receive dietary and nutritional assistance plus a food aid basket, specifically tailored to meet the nutritional needs of the target population.

OTHER

Dietary/nutrition counsel

Patients enrolled in the active comparison arm will receive dietary and nutrition counseling designed to help them meet their nutrition needs, based on foods which are locally available, culturally acceptable and within their budget.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • RAND

    lead OTHER

Principal Investigators

  • Homero Martinez, PhD · RAND

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01191281 on ClinicalTrials.gov