Clinical trial NCT01191281: Improving Food Security and Nutrition to Promote ART Adherence in Latin America
Official title: Improving Food Security and Nutrition to Promote ART Adherence in Latin America
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: food habits
nutrition requirements
antiretroviral therapy
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-08-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: ART uptake and adherence
timeFrame: Monthly during 12 of follow-up
measure: Nutritional status
timeFrame: Monthly during 12 months of follow-up
Secondary outcomes:
measure: HIV clinical outcomes
timeFrame: At 6 and 12 months of follow-up
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: RAND Corporation
state: California
Study officials:
affiliation: RAND
name: Homero Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References: