Abstract
BackgroundFood insecurity is an important barrier to retention in care and adherence to antiretroviral therapy (ART) among people living with HIV infection (PLHIV). However, there is a lack of rigorous evidence about how to improve food security and HIV-related clinical outcomes. To address this gap, this randomized trial will evaluate three delivery models for short-term food and nutrition support for food insecure PLHIV in Shinyanga, Tanzania: nutrition assessment and counseling (NAC) alone, NAC plus food assistance, and NAC plus cash transfers.Methods/DesignAt three HIV care and treatment sites, 788 participants will be randomized into one of three study arms in a 3:3:1 ratio, stratified by site: NAC plus food assistance, NAC plus cash transfer, and NAC only. Eligible participants are: 1) at least 18 years of age; 2) living with HIV infection; 3) initiated ART in the past 90 days; and 4) food insecure, as measured with the Household Hunger Scale. PLHIV who are severely malnourished (body mass index (BMI) < 16 kg/m2) will be excluded. Participants randomized to receive food or cash transfers are eligible to receive assistance for up to six months, conditional on attending regularly scheduled visits with their HIV care provider. Participants will be followed for 12 months: the initial 6-month intervention period and then for another 6 months post-intervention. The primary outcome is ART adherence measured with the medication possession ratio. Secondary outcomes include 1) retention in care; 2) nutritional indicators including changes in food security, BMI, and weight gain; 3) viral suppression and self-reported ART adherence; and 4) participation in the labor force.DiscussionThis rigorously designed trial will inform policy decisions regarding supportive strategies for food insecure PLHIV in the early stages of treatment. The study will measure outcomes immediately after the period of support ends as well as 6 months later, providing information on the duration of the interventions’ effect. The comparison of food to cash transfers will better inform policies favoring cash assistance or will provide rationale for the continued investment in food and nutrition interventions for PLHIV.Trial registrationClinicalTrials.gov: NCT01957917.
Highlights
Food insecurity is an important barrier to retention in care and adherence to antiretroviral therapy (ART) among people living with HIV infection (PLHIV)
Background early initiation of antiretroviral therapy (ART) among people living with HIV/AIDS (PLHIV) has significant clinical benefits and can virtually eliminate onward HIV transmission [1, 2], these benefits hinge on retention in care and high levels of ART adherence
We will conduct a per protocol analysis using data from participants who received at least a minimum exposure to the interventions and for whom medication possession ratio (MPR) was available at 6 months
Summary
There is growing recognition that the individual and public health benefits of ART cannot be fully achieved without mitigating the detrimental consequences of food insecurity [6,7,8]. If this study validates the hypothesis that increased food and/or cash can mitigate food security and improve adherence, it will support the development and evaluation of livelihood interventions targeted to AIDS-affected households which aim to increase household food and economic security through training, access to productive assets (e.g., fertilizer), or financial products (e.g., microloans) [58] In this way, this study provides important proof-of-concept data that will inform both targeted food interventions for PLHIV as well as structural income-enhancing interventions that benefit the entire household. The interventions evaluated in this study are designed to mitigate food insecurity, they are not intended to examine the effect of nutritional quality on adherence or clinical outcomes.
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