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

RanD

Status: Completed

Conditions: Medication Adherence

Treatments: Behavioral: Diet/nutrition counsel+food aid; Other: Dietary/nutrition counsel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01191281

R34MH084675-02 (U.S. NIH Grant/Contract)

GRANT00395147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Diet/nutrition counsel+food aid

Experimental group

Description:

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)

Treatment:

Behavioral: Diet/nutrition counsel+food aid

dietary/nutritional counseling

Active Comparator group

Description:

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.

Treatment:

Other: Dietary/nutrition counsel