Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
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ClinicalTrials.gov Identifier: NCT01957917 |
Recruitment Status :
Completed
First Posted : October 8, 2013
Last Update Posted : March 31, 2020
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Condition or disease | Intervention/treatment | Phase |
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HIV | Other: NAC (Nutritional Assessment and Counseling) Other: Cash Transfer Other: Food Assistance | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 800 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania |
Actual Study Start Date : | December 2013 |
Actual Primary Completion Date : | October 2016 |
Actual Study Completion Date : | September 12, 2019 |
Arm | Intervention/treatment |
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Experimental: 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.
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Other: NAC (Nutritional Assessment and Counseling) Other: Food Assistance |
Experimental: 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.
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Other: NAC (Nutritional Assessment and Counseling) Other: Cash Transfer |
Active Comparator: NAC Only
Arm 3 participants will receive NAC (nutrition assessment and counseling) only, which is the standard of care at the selected health facilities.
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Other: NAC (Nutritional Assessment and Counseling) |
- Change from baseline of Medication Possession Ratio (MPR) at 6 months and at 12 months [ Time Frame: Baseline, 6 months, 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.
- Change from baseline in Food Security at 6 months and 12 months [ Time Frame: Baseline, 6 months, 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).
- Change from baseline in Viral Suppression at 6 months and 12 months [ Time Frame: Baseline, 6 months, 12 months ]viral load <400 copies/mL
- Change from baseline in ART adherence at 6 months, 12 months, and 24-36 months [ Time Frame: Baseline, 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.
- Change from baseline in Body Mass Index (BMI) at 6 months and 12 months [ Time Frame: Baseline, 6, and 12 months ]body weight in kilograms (kg) divided by height in meters squared
- Change from baseline in Weight at 6 months and 12 months [ Time Frame: Baseline, 6 months, 12 months ]
- Change from baseline of Medication Possession Ratio (MPR) at 12-36 months [ Time Frame: 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.
- Retention in Care at 12-36 months [ Time Frame: 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
- Change from baseline in ability to work/participation in the labor force at 6 months and 12 months [ Time Frame: Baseline, 6 months, 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957917
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, Tanzania |
Principal Investigator: | Sandra I McCoy, PhD | University of California, Berkeley |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sandra McCoy, Assistant Adjunct Professor, University of California, Berkeley |
ClinicalTrials.gov Identifier: | NCT01957917 |
Other Study ID Numbers: |
5K01MH094246 ( U.S. NIH Grant/Contract ) 5K01MH094246 ( U.S. NIH Grant/Contract ) |
First Posted: | October 8, 2013 Key Record Dates |
Last Update Posted: | March 31, 2020 |
Last Verified: | March 2020 |
HIV Food Insecurity Antiretroviral Therapy |
HIV Seropositivity HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |