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Completed

NCT Number: NCT01191281

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

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.

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Key information

Conditions

Medication Adherence Behavior Behavior, Animal Feeding Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RAND Corporation

Santa Monica, California, 90047, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet/nutrition counsel+food aid

Behavioral

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.

Dietary/nutrition counsel

Other

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.

Primary outcomes

  1. ART uptake and adherence

    Time frame: Monthly during 12 of follow-up

  2. Nutritional status

    Time frame: Monthly during 12 months of follow-up

    Nutritional status will be assess by anthropometry every month during follow-up

Secondary outcomes

  1. HIV clinical outcomes

    Time frame: At 6 and 12 months of follow-up

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2010
Registry last updated
Oct 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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