Clinical trial NCT01957917: Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
Official title: Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Food Insecurity
Antiretroviral Therapy
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Ministry of Health and Social Welfare, Tanzania
First posted: 2013-10-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

1. at least 18 years of age;
2. living with HIV infection;
3. initiated antiretroviral therapy (ART) for HIV infection in the last 90 days;
4. food insecure, as measured with the Household Hunger Scale; and
5. 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).

Primary outcomes:
measure: Change from baseline of Medication Possession Ratio (MPR) at 6 months and at 12 months
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline in Food Security at 6 months and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from baseline in Viral Suppression at 6 months and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from baseline in ART adherence at 6 months, 12 months, and 24-36 months
timeFrame: Baseline, 6 months, 12 months, and 24-36 months
measure: Change from baseline in Body Mass Index (BMI) at 6 months and 12 months
timeFrame: Baseline, 6, and 12 months
measure: Change from baseline in Weight at 6 months and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from baseline of Medication Possession Ratio (MPR) at 12-36 months
timeFrame: 12-36 months
measure: Retention in Care at 12-36 months
timeFrame: 12-36 months
Other outcomes:
measure: Change from baseline in ability to work/participation in the labor force at 6 months and 12 months
timeFrame: Baseline, 6 months, 12 months
Locations:
city: Shinyanga
country: Tanzania
facility: Kahama District Hospital
state: Shinyanga Region
city: Shinyanga
country: Tanzania
facility: Kambarage Health Center
state: Shinyanga Region
city: Shinyanga
country: Tanzania
facility: Kishapu Health Center
state: Shinyanga Region
city: Shinyanga
country: Tanzania
facility: Shinyanga Regional Hospital
state: Shinyanga Region
Study officials:
affiliation: University of California, Berkeley
name: Sandra I McCoy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deitchler M, Ballard T, Swindale A, Coates J. Introducing a Simple Measure of Household Hunger for Cross-Cultural Use. Washington, D.C.: Food and Nutrition Technical Assistance II Project, AED;2011.
citation: McMahon JH, Jordan MR, Kelley K, Bertagnolio S, Hong SY, Wanke CA, Lewin SR, Elliott JH. Pharmacy adherence measures to assess adherence to antiretroviral therapy: review of the literature and implications for treatment monitoring. Clin Infect Dis. 2011 Feb 15;52(4):493-506. doi: 10.1093/cid/ciq167. Epub 2011 Jan 18.
citation: Messou E, Chaix ML, Gabillard D, Minga A, Losina E, Yapo V, Kouakou M, Danel C, Sloan C, Rouzioux C, Freedberg KA, Anglaret X. Association between medication possession ratio, virologic failure and drug resistance in HIV-1-infected adults on antiretroviral therapy in Cote d'Ivoire. J Acquir Immune Defic Syndr. 2011 Apr;56(4):356-64. doi: 10.1097/QAI.0b013e3182084b5a.
citation: Goldman JD, Cantrell RA, Mulenga LB, Tambatamba BC, Reid SE, Levy JW, Limbada M, Taylor A, Saag MS, Vermund SH, Stringer JS, Chi BH. Simple adherence assessments to predict virologic failure among HIV-infected adults with discordant immunologic and clinical responses to antiretroviral therapy. AIDS Res Hum Retroviruses. 2008 Aug;24(8):1031-5. doi: 10.1089/aid.2008.0035.
citation: Hong S, Nachega J, Jerger L, et al. Medication Possession Ratio Predictive of Short-term Virologic and Immunologic Response in Individuals Initiating ART: Namibia. 19th Conference on Retroviruses and Opportunistic Infections. Seattle 2012.
citation: Coates J, Swindale A, Bilinsky P. Household Food Insecurity Access Scale (HFIAS) for Measurement of Food Access: Indicator Guide. Washington, D.C.: United States Agency for International Development;2007.
citation: Swindale A, Bilinsky P. Household Dietary Diversity Score (HDDS) for Measurement of Household Food Access: Indicator Guide (v.2). Washington, D.C.: Food and Nutrition Technical Assistance Project, Academy for Educational Development;2006.
citation: Fahey CA, Njau PF, Kelly NK, Mfaume RS, Bradshaw PT, Dow WH, McCoy SI. Durability of effects from short-term economic incentives for clinic attendance among HIV positive adults in Tanzania: long-term follow-up of a randomised controlled trial. BMJ Glob Health. 2021 Dec;6(12):e007248. doi: 10.1136/bmjgh-2021-007248.
citation: McCoy SI, Njau PF, Fahey C, Kapologwe N, Kadiyala S, Jewell NP, Dow WH, Padian NS. Cash vs. food assistance to improve adherence to antiretroviral therapy among HIV-infected adults in Tanzania. AIDS. 2017 Mar 27;31(6):815-825. doi: 10.1097/QAD.0000000000001406.
citation: McCoy SI, Njau PF, Czaicki NL, Kadiyala S, Jewell NP, Dow WH, Padian NS. 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 Infect Dis. 2015 Oct 28;15:490. doi: 10.1186/s12879-015-1186-3.