Improving Food Security and Nutrition to Promote ART Adherence in Latin America
|ClinicalTrials.gov Identifier: NCT01191281|
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : October 18, 2012
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:
- Explore the relationships between food security, nutrition, and HIV treatment access, utilization, and adherence, and examine key mediators and moderators of these relationships.
- Develop a multi-component nutrition intervention to address food insecurity among Honduran HIV+ individuals and their families.
- 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).
- Examine key mediators and moderators of the intervention effects from among characteristics of the patient, household, and contextual setting.
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence||Behavioral: Diet/nutrition counsel+food aid Other: Dietary/nutrition counsel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Food Security and Nutrition to Promote ART Adherence in Latin America|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Diet/nutrition counsel+food aid
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)
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.
Active Comparator: dietary/nutritional counseling
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.
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.
- ART uptake and adherence [ Time Frame: Monthly during 12 of follow-up ]
- Nutritional status [ Time Frame: Monthly during 12 months of follow-up ]Nutritional status will be assess by anthropometry every month during follow-up
- HIV clinical outcomes [ Time Frame: At 6 and 12 months of follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191281
|United States, California|
|Santa Monica, California, United States, 90047|
|Principal Investigator:||Homero Martinez, PhD||RAND|