HIVNCT01957917
Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
A study testing NAC (Nutritional Assessment and Counseling), Cash Transfer and Food Assistance in people with HIV, run by University of California, Berkeley at 4 sites in Tanzania.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- NAC (Nutritional Assessment and Counseling), Cash Transfer and Food Assistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 4 sitesTanzania
- Study dates
- Dec 2013to 12 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
Tanzania4 sites
Kahama District Hospital
Shinyanga, Shinyanga
Kambarage Health Center
Shinyanga, Shinyanga
Kishapu Health Center
Shinyanga, Shinyanga
Shinyanga Regional Hospital
Shinyanga, Shinyanga
About this study
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.
Read the 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
- Being tested
- NAC (Nutritional Assessment and Counseling), Cash Transfer, Food Assistance
- Keywords
- HIV, Food Insecurity, Antiretroviral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAC (Nutritional Assessment and Counseling)Other
Cash TransferOther
Food AssistanceOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: NAC (Nutritional Assessment and Counseling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (7)
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).
Measured: Baseline, 6 months, 12 months
Change from baseline in Viral Suppression at 6 months and 12 months
viral load <400 copies/mL
Measured: Baseline, 6 months, 12 months
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.
Measured: Baseline, 6 months, 12 months, and 24-36 months
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
Measured: Baseline, 6, and 12 months
Change from baseline in Weight at 6 months and 12 months
Measured: Baseline, 6 months, 12 months
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.
Measured: 12-36 months
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
Measured: 12-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2016
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ministry of Health and Social Welfare, Tanzania
- Responsible party
- Principal investigator, Sandra McCoy, University of California, Berkeley
- Investigators
- Sandra I McCoy, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957917
- Sponsor's protocol ID
- 5K01MH094246
- Other IDs
- 5K01MH094246
- Status last verified
- Mar 2020
- First submitted
- 30 Sep 2013
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
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.
PubMed 21245156Messou 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.
PubMed 21191309Goldman 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.
PubMed 18724803Hong 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.
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.
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.
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.
PubMed 34952856McCoy 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.
PubMed 28107221McCoy 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.
PubMed 26520572
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
- ClinicalTrials.gov ID
- NCT01957917
- Acronym / sponsor ID
- 5K01MH094246
- Conditions
- HIV
- Keywords
- HIV, Food Insecurity, Antiretroviral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ministry of Health and Social Welfare, Tanzania
- Study start
- Dec 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NAC + Food Assistance | Experimental | Other: NAC (Nutritional Assessment and Counseling), Other: Food AssistanceArm 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. |
| NAC + Cash Transfer | Experimental | Other: NAC (Nutritional Assessment and Counseling), Other: Cash TransferArm 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. |
| NAC Only | Active comparator | Other: NAC (Nutritional Assessment and Counseling)Arm 3 participants will receive NAC (nutrition assessment and counseling) only, which is the standard of care at the selected health facilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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.
7 secondary outcomes
Change from baseline in Food Security at 6 months and 12 months
Time frame: Baseline, 6 months, 12 months
Change from baseline in Viral Suppression at 6 months and 12 months
Time frame: Baseline, 6 months, 12 months
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
Change from baseline in Body Mass Index (BMI) at 6 months and 12 months
Time frame: Baseline, 6, and 12 months
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
Retention in Care at 12-36 months
Time frame: 12-36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- BackgroundDeitchler 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: PubMed 21245156McMahon 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.
- Background: PubMed 21191309Messou 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.
- Background: PubMed 18724803Goldman 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.
- BackgroundHong 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.
- BackgroundCoates 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.
- BackgroundSwindale 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.
- Derived from this study: PubMed 34952856Fahey 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.
- Derived from this study: PubMed 28107221McCoy 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.
- Derived from this study: PubMed 26520572McCoy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra I McCoy, PhD principal investigator
University of California, Berkeley
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAC (Nutritional Assessment and Counseling), Cash Transfer and Food Assistance in people with HIV, run by University of California, Berkeley at 4 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Medication Possession Ratio (MPR) at 6 months and at 12 months (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01957917, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.