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

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Behavioral: Diet/nutrition counsel+food aid; Other: Dietary/nutrition counsel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90047
      • RAND Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ART uptake and adherence		Monthly during 12 of follow-up
Nutritional status	Nutritional status will be assess by anthropometry every month during follow-up	Monthly during 12 months of follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
HIV clinical outcomes	At 6 and 12 months of follow-up

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Homero Martinez, PhD, RAND

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (Estimate): August 30, 2010

Study Record Updates

• Last Update Posted (Estimate): October 18, 2012
• Last Update Submitted That Met QC Criteria: October 17, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: antiretroviral therapy; nutrition requirements; food habits
• Other Study ID Numbers: GRANT00395147; R34MH084675-02 (U.S. NIH Grant/Contract)