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

NCT01191281 | Completed

• 2 other identifiers: GRANT00395147R34MH084675-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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. 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. 2.Develop a multi-component nutrition intervention to address food insecurity among Honduran HIV+ individuals and their families.
3. 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. 4.Examine key mediators and moderators of the intervention effects from among characteristics of the patient, household, and contextual setting.

Conditions

Medication Adherence

Keywords

food habits; nutrition requirements; antiretroviral therapy

Outcome Measures

Primary Outcomes (2)

• ART uptake and adherence

  Monthly during 12 of follow-up

• Nutritional status

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

  Monthly during 12 months of follow-up

Secondary Outcomes (1)

• HIV clinical outcomes

  At 6 and 12 months of follow-up

Study Arms (2)

Diet/nutrition counsel+food aid

EXPERIMENTAL

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

dietary/nutritional counseling

ACTIVE COMPARATOR

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

Interventions

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.

Diet/nutrition counsel+food aid

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.

dietary/nutritional counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Registered at the clinic
• Age 18 or older
• If not on ART, CD4 \< 350\*
• Living in the area for the past year.

You may not qualify if:

• Deterioration of clinical status such that requires diet or nutrition therapy
• Cannot understand or speak Spanish

Sponsors & Collaborators

• RAND: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

RAND Corporation

Santa Monica, California, 90047, United States

Location

MeSH Terms

Conditions

Medication Adherence; Feeding Behavior

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Homero Martinez, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Social Scientist

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 30, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

US (1)