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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191281
• Other study ID #: GRANT00395147
• Secondary ID: R34MH084675-02
• Status: Completed
• Phase: N/A
• First received: August 26, 2010
• Last updated: October 17, 2012
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
United States	RAND Corporation	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
RAND	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ART uptake and adherence		Monthly during 12 of follow-up	No
Primary	Nutritional status	Nutritional status will be assess by anthropometry every month during follow-up	Monthly during 12 months of follow-up	No
Secondary	HIV clinical outcomes		At 6 and 12 months of follow-up	No