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

NCT ID: NCT01191281

Last Updated: 2012-10-18

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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The project will be conducted in two phases. Phase 1 involves qualitative, formative research methods to (1) gain understanding of availability and cost of the local foods and the regular diet, (2) evaluate the level of food security among people living with HIV, including intra-household food distribution patterns, and assess the nutritional status of HIV affected individuals, and (3) examine the role that food security and nutrition play in HIV treatment access, utilization and adherence. Phase 2 consists of developing and pilot-testing a multi-component nutrition intervention through a randomized, controlled trial conducted at 4 HIV clinics in Honduras, with two clinics randomly assigned to receive the intervention and two clinics to serve as the comparison group. Patients at each of the 4 sites will receive nutrition counseling, following the guidelines currently proposed by the World Health Organization (WHO) as the standard of care for HIV-infected individuals. In addition, clients at the intervention sites will receive food assistance in the form of a food-aid basket, designed ad hoc to address their macro and micronutrient needs.

Conditions

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Medication Adherence

Keywords

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food habits nutrition requirements antiretroviral therapy

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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Diet/nutrition counsel+food aid

Intervention. Patients enrolled in the intervention group will receive a multi-component intervention that includes dietary and nutritional counseling and food assistance (food aid basket)

Group Type EXPERIMENTAL

Diet/nutrition counsel+food aid

Intervention Type BEHAVIORAL

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.

dietary/nutritional counseling

Patients enrolled in the 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.

Group Type ACTIVE_COMPARATOR

Dietary/nutrition counsel

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Registered at the clinic
* Age 18 or older
* If not on ART, CD4 \< 350\*
* Living in the area for the past year.

Exclusion Criteria

* Deterioration of clinical status such that requires diet or nutrition therapy
* Cannot understand or speak Spanish
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

RAND

OTHER

Sponsor Role lead

Responsible Party

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Homero Martinez

Senior Social Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Homero Martinez, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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RAND Corporation

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH084675-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GRANT00395147

Identifier Type: -

Identifier Source: org_study_id