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Trial record 3 of 34 for:    " September 30, 2013":" October 30, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of California, Berkeley
Sponsor:
Collaborators:
Ministry of Health and Social Welfare, Tanzania
Information provided by (Responsible Party):
Sandra McCoy, University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT01957917
First received: September 30, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

The importance of good nutrition and food security among people living with HIV infection (PLHIV) is widely recognized. In resource-constrained settings, food insecurity is increasingly recognized as an important barrier to retention in care and adherence to antiretroviral therapy (ART). However, there are few studies demonstrating that food and nutrition assistance programs can improve HIV-related outcomes. This study will address this gap by comparing the effectiveness of three models for short-term support for PLHIV. Food insecure women and men on ART will be randomized into one of three groups: 1) nutrition assessment and counseling (NAC) alone, 2) NAC plus food assistance, or 3) NAC plus cash transfers. The investigators will compare the effect of the three approaches on ART adherence and retention in care after 6 and 12 months of follow-up. The investigators hypothesize that NAC plus short-term support in the form of food or cash assistance will result in better adherence to ART and retention in care than NAC alone, and that the effects of NAC plus food assistance will be the same as NAC plus cash assistance. The results from the study will provide evidence about which assistance modalities for PLHIV work best to improve ART adherence and retention in care, and under what conditions. This study will be conducted in Shinyanga Region, Tanzania, where approximately 17 percent of households have poor or borderline food consumption and 7.4 percent of people are living with HIV infection.


Condition Intervention
HIV
Other: NAC (Nutritional Assessment and Counseling)
Other: Cash Transfer
Other: Food Assistance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

Resource links provided by NLM:


Further study details as provided by University of California, Berkeley:

Primary Outcome Measures:
  • Change from baseline of Medication Possession Ratio (MPR) at 6 months and at 12 months [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    ART adherence will be measured with the medication possession ratio (MPR), the proportion of time an individual is in possession of >1 ARV or prescription for ARV. MPR is computed as the number of days ARVs are prescribed or dispensed divided by the number of days in the interval, and has been shown to be associated with short-term virologic outcomes. We will determine the proportion of patients with MPR ≥95% in each of the study arms.


Secondary Outcome Measures:
  • Change from baseline in Food Security at 6 months and 12 months [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Food security will be measured with several validated scales: the Household Food Insecurity Access Scale (HFIAS), the Household Hunger Scale (HHS) and the Individual Dietary Diversity Scale (IDDS).

  • Change from baseline in Viral Suppression at 6 months and 12 months [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    viral load <400 copies/mL

  • Change from baseline in ART adherence at 6 months and 12 months [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Proportion of patients who report taking at least 95% of prescribed doses in the previous month time frame. This will be measured by self-report.

  • Change from baseline in Body Mass Index (BMI) at 6 months and 12 months [ Time Frame: Baseline, 6, and 12 months ] [ Designated as safety issue: No ]
    body weight in kilograms (kg) divided by height in meters squared

  • Change from baseline in Weight at 6 months and 12 months [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from baseline in ability to work/participation in the labor force at 6 months and 12 months [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 785
Study Start Date: December 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NAC + Food Assistance
Arm 1 participants will receive NAC (nutritional assessment and counseling), plus a food ration once a month for 6 months if they continue their regular HIV care.
Other: NAC (Nutritional Assessment and Counseling) Other: Food Assistance
Experimental: NAC + Cash Transfer
Arm 2 participants will receive NAC (nutritional assessment and counseling), plus a cash transfer equivalent in value to the food transfer once a month for 6 months if they continue their regular HIV care.
Other: NAC (Nutritional Assessment and Counseling) Other: Cash Transfer
Active Comparator: NAC Only
Arm 3 participants will receive NAC (nutrition assessment and counseling) only, which is the standard of care at the selected health facilities.
Other: NAC (Nutritional Assessment and Counseling)

Detailed Description:

The investigators will randomize 785 food insecure women and men who recently initiated ART (determined with the Household Hunger Scale1) into one of three groups: 1) NAC alone , 2) NAC plus food assistance, or 3) NAC plus cash transfers. Food assistance will be a standard food ration consisting of maize flour, groundnuts, and beans. The cash transfer will be the equivalent value as the food ration (approximately $13 USD/month). Participants will receive the monthly food ration or cash transfer for up to six months if they continue to receive monthly HIV care (the standard of care). The investigators will compare the effect of NAC and food or cash assistance to the effect of NAC alone on ART adherence and retention in care at 6 and 12 months (Objective #1). The investigators will also compare the effectiveness of NAC plus food assistance and NAC plus cash transfers to determine if their effects are the same (Objective #2).


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. at least 18 years of age;
  2. living with HIV infection;
  3. initiated antiretroviral therapy (ART) for HIV infection in the last 90 days;
  4. food insecure, as measured with the Household Hunger Scale; and
  5. willing and able to provide written informed consent for the study.

Exclusion Criteria:

PLHIV who are severely malnourished (BMI<18.5) will be excluded from the study, as these individuals require therapeutic food support (ready-to-use food products for nutritional recovery). In this study, we will enroll food insecure PLHIV who are at risk of malnutrition but are not severely malnourished (BMI>18.5).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957917

Contacts
Contact: Sandra I McCoy, MPH, PhD 510-642-0534 smccoy@berkeley.edu
Contact: Prosper F Njau, MD prosperpendo@gmail.com

Locations
Tanzania
Kahama District Hospital Not yet recruiting
Shinyanga, Shinyanga Region, Tanzania
Contact: Sandra McCoy, MPH, PhD       smccoy@berkeley.edu   
Contact: Prosper Pendo, MD       prosperpendo@gmail.com   
Principal Investigator: Prosper Njau, MD         
Kambarage Health Center Not yet recruiting
Shinyanga, Shinyanga Region, Tanzania
Contact: Sandra McCoy, MPH, PhD       smccoy@berkeley.edu   
Contact: Prosper Pendo, MD       prosperpendo@gmail.com   
Principal Investigator: Prosper Njau, MD         
Kishapu Health Center Not yet recruiting
Shinyanga, Shinyanga Region, Tanzania
Contact: Sandra McCoy, MPH, PhD       smccoy@berkeley.edu   
Contact: Prosper Pendo, MD       prosperpendo@gmail.com   
Principal Investigator: Prosper Njau, MD         
Shinyanga Regional Hospital Recruiting
Shinyanga, Shinyanga Region, Tanzania
Contact: Sandra McCoy, MPH, Phd       smccoy@berkeley.edu   
Contact: Prosper Pendo, MD       prosperpendo@gmail.com   
Principal Investigator: Prosper Njau, MD         
Sponsors and Collaborators
University of California, Berkeley
Ministry of Health and Social Welfare, Tanzania
Investigators
Principal Investigator: Sandra I McCoy, PhD University of California, Berkeley
  More Information

Publications:
Responsible Party: Sandra McCoy, Assistant Adjunct Professor, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT01957917     History of Changes
Other Study ID Numbers: 5K01MH094246, 5K01MH094246
Study First Received: September 30, 2013
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by University of California, Berkeley:
HIV
Food Insecurity
Antiretroviral Therapy

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014