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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957917
• Other study ID #: 5K01MH094246
• Secondary ID: 5K01MH094246
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: September 12, 2019

Study information

• Verified date: March 2020
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: September 12, 2019
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• HIV
• HIV Seropositivity

Intervention

Other:
• NAC (Nutritional Assessment and Counseling)

• Cash Transfer

• Food Assistance

Locations

Country	Name	City	State
Tanzania	Kahama District Hospital	Shinyanga	Shinyanga Region
Tanzania	Kambarage Health Center	Shinyanga	Shinyanga Region
Tanzania	Kishapu Health Center	Shinyanga	Shinyanga Region
Tanzania	Shinyanga Regional Hospital	Shinyanga	Shinyanga Region

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Berkeley	Ministry of Health and Social Welfare, Tanzania, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Tanzania, 

References & Publications (7)

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.

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.

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. — View 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.

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. — View 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 Côte d'Ivoire. J Acquir Immune Defic Syndr. 2011 Apr;56(4):356-64. doi: 10.1097/QAI.0b013e3182084b5a. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in ability to work/participation in the labor force at 6 months and 12 months		Baseline, 6 months, 12 months
Primary	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	Change from baseline in Food Security at 6 months and 12 months	Food security will be measured with several validated scales: the Household Food Insecurity Access Scale (HFIAS), the Household Hunger Scale (HHS) and the Individual Dietary Diversity Scale (IDDS).	Baseline, 6 months, 12 months
Secondary	Change from baseline in Viral Suppression at 6 months and 12 months	viral load <400 copies/mL	Baseline, 6 months, 12 months
Secondary	Change from baseline in ART adherence at 6 months, 12 months, and 24-36 months	Proportion of patients who report taking at least 95% of prescribed doses in the previous month time frame. This will be measured by self-report.	Baseline, 6 months, 12 months, and 24-36 months
Secondary	Change from baseline in Body Mass Index (BMI) at 6 months and 12 months	body weight in kilograms (kg) divided by height in meters squared	Baseline, 6, and 12 months
Secondary	Change from baseline in Weight at 6 months and 12 months		Baseline, 6 months, 12 months
Secondary	Change from baseline of Medication Possession Ratio (MPR) at 12-36 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 arm.	12-36 months
Secondary	Retention in Care at 12-36 months	Retention in care will be assessed by number of participants in each arm that are still still in care at 12-36 months	12-36 months