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

NCT ID: NCT01957917

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2019-09-12

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).

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

NAC + Food Assistance

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.

Group Type: EXPERIMENTAL

NAC (Nutritional Assessment and Counseling)

Intervention Type: OTHER

Food Assistance

Intervention Type: OTHER

NAC + Cash Transfer

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.

Group Type: EXPERIMENTAL

NAC (Nutritional Assessment and Counseling)

Intervention Type: OTHER

Cash Transfer

Intervention Type: OTHER

NAC Only

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

Group Type: ACTIVE_COMPARATOR

NAC (Nutritional Assessment and Counseling)

Intervention Type: OTHER

Interventions

NAC (Nutritional Assessment and Counseling)

Intervention Type: OTHER

Cash Transfer

Intervention Type: OTHER

Food Assistance

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Ministry of Health and Social Welfare, Tanzania

OTHER_GOV

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Sandra McCoy

Assistant Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra I McCoy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

Kahama District Hospital

Shinyanga, Shinyanga, Tanzania

Kambarage Health Center

Shinyanga, Shinyanga, Tanzania

Kishapu Health Center

Shinyanga, Shinyanga, Tanzania

Shinyanga Regional Hospital

Shinyanga, Shinyanga, Tanzania

Countries

Tanzania

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 21245156 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21191309 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18724803 (View on PubMed)

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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 34952856 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28107221 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26520572 (View on PubMed)

Other Identifiers

5K01MH094246

Identifier Type: NIH

Identifier Source: secondary_id

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5K01MH094246

Identifier Type: NIH

Identifier Source: org_study_id

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