HIVNCT02095613
Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care
A study testing traditional food and food that is nutrient dense in people with HIV and Food Insecurity, run by Brigham and Women's Hospital at 1 site in Haiti.
Trial summary
The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Food Insecurity, Malnutrition
- What is being tested?
- traditional food and food that is nutrient dense
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 623 participants
- Where
- 1 siteHaiti
- Study dates
- May 2010to Jul 2016
- 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
- documented to have HIV infection by standard laboratory procedures
- live in the geographic catchment area of PIH services where study is taking place
- 18 years of age or older
- started antiretroviral therapy for HIV in the 24 months prior to study enrollment
Who cannot join
- if another household member is also eligible for food assistance
- if subject is pregnant at the time of enrollment
- if unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Ready-to-use-supplementary Food Compared to Corn-soy-blend+ as Food Rations for HIV-infected Adults on Antiretroviral Therapy in Rural Haiti
The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation.
- Conditions
- HIV, Food Insecurity, Malnutrition
- Being tested
- traditional food, food that is nutrient dense
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional foodOther
food that is nutrient denseOther
| Study group | Role | What they receive |
|---|---|---|
| Corn-soy-blend plus | Active comparator | food A type of ground meal called corn-soy-blend plus Receives: Other: traditional food |
| Ready-to-use-supplementary food | Active comparator | food A nutrient dense food comprised of peanuts, oil, multivitamins. Receives: Other: food that is nutrient dense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index over time
Measured: 6-month, 12-month
Secondary outcomes (1)
Change in Quality of Life over time
Measured: 6-month, 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Partners in Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Louise Ivers, MD, Brigham and Women's Hospital
- Investigators
- Louise Ivers, MB, BCh, BAO, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095613
- Sponsor's protocol ID
- 2008P002017/BWH
- Other IDs
- R01HD057627
- Status last verified
- Aug 2016
- First submitted
- 20 Mar 2014
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Ready-to-use-supplementary Food Compared to Corn-soy-blend+ as Food Rations for HIV-infected Adults on Antiretroviral Therapy in Rural Haiti
- ClinicalTrials.gov ID
- NCT02095613
- Acronym / sponsor ID
- 2008P002017/BWH
- Conditions
- HIV, Food Insecurity, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Partners in Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Mar 2014 (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 study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corn-soy-blend plus | Active comparator | Other: traditional foodfood A type of ground meal called corn-soy-blend plus |
| Ready-to-use-supplementary food | Active comparator | Other: food that is nutrient densefood A nutrient dense food comprised of peanuts, oil, multivitamins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- documented to have HIV infection by standard laboratory procedures
- live in the geographic catchment area of PIH services where study is taking place
- 18 years of age or older
- started antiretroviral therapy for HIV in the 24 months prior to study enrollment
Key exclusion criteria (3 listed)
- if another household member is also eligible for food assistance
- if subject is pregnant at the time of enrollment
- if unable to give informed consent
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 |
|---|---|---|
| traditional food | Other | Corn-soy-blend plus |
| food that is nutrient dense | Other | Ready-to-use-supplementary food |
Primary outcome
Change in Body Mass Index over time
Time frame: 6-month, 12-month
1 secondary outcome
Change in Quality of Life over time
Time frame: 6-month, 12-month
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 11 Aug 2016.
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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.
Louise Ivers, MB, BCh, BAO principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional food and food that is nutrient dense in people with HIV and Food Insecurity, run by Brigham and Women's Hospital at 1 site in Haiti.
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 4 inclusion and 3 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. 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 in Body Mass Index over time (time frame: 6-month, 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2016.