Rationale and design of a randomized study of short-term food and cash assistance to improve adherence to antiretroviral therapy among food insecure HIV-infected adults in Tanzania

BMC Infectious Diseases

Nancy S. Padian¹  William H. Dow¹  Nicholas P. Jewell¹  Suneetha Kadiyala³  Nancy L. Czaicki¹  Prosper F. Njau²  Sandra I. McCoy¹ 

[1] School of Public Health, University of California, Berkeley, Berkeley, CA, USA;Ministry of Health and Social Welfare, Dar es Salaam, Tanzania;London School of Hygiene and Tropical Medicine, Room 305, 36 Gordon Square London WC1H 0PD, London, UK

关键词: Food assistance;    Cash transfers;    Impact evaluation;    Retention;    Adherence;    HIV infection;    Food security;   

Others  :  1232692
DOI  :  10.1186/s12879-015-1186-3

 received in 2015-07-03, accepted in 2015-10-07,  发布年份 2015

【 摘 要 】

Background

Food 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/Design

At 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/m ² ) 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.

Discussion

This 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 registration

ClinicalTrials.gov: NCT01957917.

【 授权许可】

   
2015 McCoy et al.

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