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Completed

NCT Number: NCT01957917

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

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, 12, and 24-36 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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahama District Hospital, Shinyanga, Tanzania

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About this study

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, 12, and 24-36 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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • at least 18 years of age;
  • living with HIV infection;
  • initiated antiretroviral therapy (ART) for HIV infection in the last 90 days;
  • food insecure, as measured with the Household Hunger Scale; and
  • 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).

Treatment and study plan

NAC (Nutritional Assessment and Counseling)

Other

Cash Transfer

Other

Food Assistance

Other

Primary outcomes

  1. Change from baseline of Medication Possession Ratio (MPR) at 6 months and at 12 months

    Time frame: Baseline, 6 months, 12 months

    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 outcomes

  1. Change from baseline in Food Security at 6 months and 12 months

    Time frame: Baseline, 6 months, 12 months

    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).

  2. Change from baseline in Viral Suppression at 6 months and 12 months

    Time frame: Baseline, 6 months, 12 months

    viral load <400 copies/mL

  3. Change from baseline in ART adherence at 6 months, 12 months, and 24-36 months

    Time frame: Baseline, 6 months, 12 months, and 24-36 months

    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.

  4. Change from baseline in Body Mass Index (BMI) at 6 months and 12 months

    Time frame: Baseline, 6, and 12 months

    body weight in kilograms (kg) divided by height in meters squared

  5. Change from baseline in Weight at 6 months and 12 months

    Time frame: Baseline, 6 months, 12 months

  6. Change from baseline of Medication Possession Ratio (MPR) at 12-36 months

    Time frame: 12-36 months

    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 arm.

  7. Retention in Care at 12-36 months

    Time frame: 12-36 months

    Retention in care will be assessed by number of participants in each arm that are still still in care at 12-36 months

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • Ministry of Health and Social Welfare, Tanzania
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
Oct 8, 2013
Registry last updated
Mar 31, 2020

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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