Improving Food Security and Nutrition to Promote ART Adherence in Latin America
Condition: Medication Adherence
Study type: Interventional

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.
    

Intervention name(s): Diet/nutrition counsel+food aid; Dietary/nutrition counsel
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: food habits; nutrition requirements; antiretroviral therapy