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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Homero Martinez, RAND
ClinicalTrials.gov Identifier:
NCT01191281
First received: August 26, 2010
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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.

Condition Intervention
Medication Adherence
Behavioral: Diet/nutrition counsel+food aid
Other: Dietary/nutrition counsel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Food Security and Nutrition to Promote ART Adherence in Latin America

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • ART uptake and adherence [ Time Frame: Monthly during 12 of follow-up ] [ Designated as safety issue: No ]
  • Nutritional status [ Time Frame: Monthly during 12 months of follow-up ] [ Designated as safety issue: No ]
    Nutritional status will be assess by anthropometry every month during follow-up


Secondary Outcome Measures:
  • HIV clinical outcomes [ Time Frame: At 6 and 12 months of follow-up ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191281

Locations
United States, California
RAND Corporation
Santa Monica, California, United States, 90047
Sponsors and Collaborators
RAND
Investigators
Principal Investigator: Homero Martinez, PhD RAND Corporation
  More Information

No publications provided

Responsible Party: Homero Martinez, Senior Social Scientist, RAND
ClinicalTrials.gov Identifier: NCT01191281     History of Changes
Other Study ID Numbers: GRANT00395147, R34MH084675-02
Study First Received: August 26, 2010
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by RAND:
food habits
nutrition requirements
antiretroviral therapy

ClinicalTrials.gov processed this record on July 31, 2014