Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

NCT01957917 | Completed

• 1 other identifier: 5K01MH094246
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV

Keywords

HIV; Food Insecurity; Antiretroviral Therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline of Medication Possession Ratio (MPR) at 6 months and at 12 months

  ART adherence will be measured with the medication possession ratio (MPR), the proportion of time an individual is in possession of \>1 ARV or prescription for ARV. MPR is computed as the number of days ARVs are prescribed or dispensed divided by the number of days in the interval, and has been shown to be associated with short-term virologic outcomes. We will determine the proportion of patients with MPR ≥95% in each of the study arms.

  Baseline, 6 months, 12 months

Secondary Outcomes (7)

• Change from baseline in Food Security at 6 months and 12 months

  Baseline, 6 months, 12 months

• Change from baseline in Viral Suppression at 6 months and 12 months

  Baseline, 6 months, 12 months

• Change from baseline in ART adherence at 6 months, 12 months, and 24-36 months

  Baseline, 6 months, 12 months, and 24-36 months

• Change from baseline in Body Mass Index (BMI) at 6 months and 12 months

  Baseline, 6, and 12 months

• Change from baseline in Weight at 6 months and 12 months

  Baseline, 6 months, 12 months

Other Outcomes (1)

• Change from baseline in ability to work/participation in the labor force at 6 months and 12 months

  Baseline, 6 months, 12 months

Study Arms (3)

NAC + Food Assistance

EXPERIMENTAL

Arm 1 participants will receive NAC (nutritional assessment and counseling), plus a food ration once a month for 6 months if they continue their regular HIV care.

Other: NAC (Nutritional Assessment and Counseling); Other: Food Assistance

NAC + Cash Transfer

EXPERIMENTAL

Arm 2 participants will receive NAC (nutritional assessment and counseling), plus a cash transfer equivalent in value to the food transfer once a month for 6 months if they continue their regular HIV care.

Other: NAC (Nutritional Assessment and Counseling); Other: Cash Transfer

NAC Only

ACTIVE COMPARATOR

Arm 3 participants will receive NAC (nutrition assessment and counseling) only, which is the standard of care at the selected health facilities.

Other: NAC (Nutritional Assessment and Counseling)

Interventions

NAC (Nutritional Assessment and Counseling) OTHER

NAC + Cash Transfer; NAC + Food Assistance; NAC Only

Cash Transfer OTHER

NAC + Cash Transfer

Food Assistance OTHER

NAC + Food Assistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Berkeley: lead
• National Institute of Mental Health (NIMH): collaborator
• Ministry of Health and Social Welfare, Tanzania: collaborator

Study Sites (4)

Kahama District Hospital

Shinyanga, Shinyanga, Tanzania

Location

Kambarage Health Center

Shinyanga, Shinyanga, Tanzania

Location

Kishapu Health Center

Shinyanga, Shinyanga, Tanzania

Location

Shinyanga Regional Hospital

Shinyanga, Shinyanga, Tanzania

Location

Related Publications (10)

• 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.

  BACKGROUND

• 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.

  PMID: 21245156 BACKGROUND

• 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.

  PMID: 21191309 BACKGROUND

• 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.

  PMID: 18724803 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34952856 DERIVED

• 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.

  PMID: 28107221 DERIVED

• 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.

  PMID: 26520572 DERIVED

MeSH Terms

Interventions

Nutrition Assessment; Counseling; Food Assistance

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations

Study Officials

• Sandra I McCoy, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Adjunct Professor

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: September 12, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

TA (4)