Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
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About
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.
Full 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, 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).
Enrollment
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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).
Trial design
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Interventional model
Masking
800 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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