title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01957917.
authors.affiliation: School of Public Health, University of California, Berkeley, Berkeley, CA, USA. smccoy@berkeley.edu.
authors.forename: Sandra I
authors.initials: SI
authors.lastname: McCoy
authors.affiliation: Ministry of Health and Social Welfare, Dar es Salaam, Tanzania. prosperpendo@gmail.com.
authors.forename: Prosper F
authors.initials: PF
authors.lastname: Njau
authors.affiliation: School of Public Health, University of California, Berkeley, Berkeley, CA, USA. nczaicki@berkeley.edu.
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Czaicki
authors.affiliation: London School of Hygiene and Tropical Medicine, Room 305, 36 Gordon Square London WC1H 0PD, London, UK. Suneetha.Kadiyala@lshtm.ac.uk.
authors.forename: Suneetha
authors.initials: S
authors.lastname: Kadiyala
authors.affiliation: School of Public Health, University of California, Berkeley, Berkeley, CA, USA. jewell@berkeley.edu.
authors.forename: Nicholas P
authors.initials: NP
authors.lastname: Jewell
authors.affiliation: School of Public Health, University of California, Berkeley, Berkeley, CA, USA. wdow@berkeley.edu.
authors.forename: William H
authors.initials: WH
authors.lastname: Dow
authors.affiliation: School of Public Health, University of California, Berkeley, Berkeley, CA, USA. npadian@berkeley.edu.
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Padian
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D015992:Body Mass Index; D003376:Counseling; D005191:Family Characteristics; D005523:Food Supply; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D015596:Nutrition Assessment; D010349:Patient Compliance / Q000706:statistics & numerical data; D057566:Self Report; D013636:Tanzania
chemical_list: D044966:Anti-Retroviral Agents