HIV and Tuberculosis Co-infectionNCT03711721
Nutritional Support for HIV-Tuberculosis Co-infected Adults in Senegal, West Africa
A study testing Food basket and Ready-to-Use Therapeutic Food in people with HIV and Tuberculosis Co-infection, run by University of Washington.
Trial summary
Food insecurity can contribute to poor adherence to both tuberculosis treatment and antiretroviral therapy (ART). Interventions that target food insecurity have the potential to improve treatment adherence and decrease mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV and Tuberculosis Co-infection
- What is being tested?
- Food basket and Ready-to-Use Therapeutic Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 2017
- 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
- HIV-Tuberculosis co-infection
- Age ≥18 years
- Initiating treatment for tuberculosis
- Provide written informed consent
Who cannot join
- Unwilling or unable to provide written informed consent
About this study
Official title: Nutritional Support to Improve Adherence and Treatment Completion Among HIV-Tuberculosis Co-infected Adults in Senegal, West Africa: A Randomized Pilot Implementation Study
Food insecurity can contribute to poor adherence to both tuberculosis treatment and antiretroviral therapy (ART). Interventions that target food insecurity have the potential to improve treatment adherence and decrease mortality. The goals of this study were to determine the cost, feasibility, acceptability, and potential impact of implementing nutritional support to improve adherence and treatment completion among HIV-TB co-infected adults in the Casamance region of Senegal, West Africa.
- Conditions
- HIV and Tuberculosis Co-infection
- Being tested
- Food basket, Ready-to-Use Therapeutic Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food basketDietary supplement
Ready-to-Use Therapeutic FoodDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Food basket | Experimental | Not described Receives: Dietary Supplement: Food basket |
| Ready-to-Use Therapeutic Food | Experimental | Not described Receives: Dietary Supplement: Ready-to-Use Therapeutic Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects.
Measured: 6 months
Acceptability, as determined by patient reported perceptions of nutritional support.
Measured: 6 months
Costs of monthly nutritional support rations.
Measured: 6 months
Secondary outcomes (12)
Tuberculosis treatment adherence as determined by Medication Possession Ratio
Measured: 6 months
Tuberculosis treatment adherence as determined by patient reported number of missed doses in the previous 7 days and 4 weeks.
Measured: 6 months
Tuberculosis treatment completion defined as completing full course of prescribed therapy
Measured: 6 months
Adherence to antiretroviral therapy as determined by Medication Possession Ratio
Measured: 6 months
Adherence to antiretroviral therapy as determined by patient reported number of missed doses in the previous 7 days and 4 weeks
Measured: 6 months
CD4 cell count
Measured: 6 months
Presence of acid fast bacteria using sputum smear microscopy
Measured: 6 months
Results of GeneXpert
Measured: 6 months
Nutritional status as determined by Body Mass Index
Measured: 6 months
Nutritional status as determined by change in weight (kg)
Measured: 6 months
Food security status measured using the Household Food Insecurity Access Scale (HFIAS)
The HFIAS is a 9-item questionnaire which provides a household food insecurity score on a scale of 1-4, with 1 being not food insecure, 2 being mildly food insecure, 3 being moderately food insecure, and 4 being severely food insecure.
Measured: 6 months
Hemoglobin levels (g/dl)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study startJun 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV and Tuberculosis Co-infectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann
- Responsible party
- Principal investigator, Noelle Benzekri, University of Washington
- Investigators
- Noelle A Benzekri, MD, Principal investigator, University of WashingtonMoussa Seydi, MD, Principal investigator, La Clinique des Maladies Infectieuses, CHNU de Fann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711721
- Sponsor's protocol ID
- 20150056
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benzekri NA, Sambou JF, Tamba IT, Diatta JP, Sall I, Cisse O, Thiam M, Bassene G, Badji NM, Faye K, Sall F, Malomar JJ, Seydi M, Gottlieb GS. Nutrition support for HIV-TB co-infected adults in Senegal, West Africa: A randomized pilot implementation study. PLoS One. 2019 Jul 18;14(7):e0219118. doi: 10.1371/journal.pone.0219118. eCollection 2019.
PubMed 31318879
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Support to Improve Adherence and Treatment Completion Among HIV-Tuberculosis Co-infected Adults in Senegal, West Africa: A Randomized Pilot Implementation Study
- ClinicalTrials.gov ID
- NCT03711721
- Acronym / sponsor ID
- 20150056
- Conditions
- HIV and Tuberculosis Co-infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 18 Oct 2018 (actual)
- 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.
Food insecurity can contribute to poor adherence to both tuberculosis treatment and antiretroviral therapy (ART). Interventions that target food insecurity have the potential to improve treatment adherence and decrease mortality. The goals of this study were to determine the cost, feasibility, acceptability, and potential impact of implementing nutritional support to improve adherence and treatment completion among HIV-TB co-infected adults in the Casamance region of Senegal, West Africa.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food basket | Experimental | Dietary Supplement: Food basket |
| Ready-to-Use Therapeutic Food | Experimental | Dietary Supplement: Ready-to-Use Therapeutic Food |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-Tuberculosis co-infection
- Age ≥18 years
- Initiating treatment for tuberculosis
- Provide written informed consent
Key exclusion criteria (1 listed)
- Unwilling or unable to provide written 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 |
|---|---|---|
| Food basket | Dietary supplement | Food basket |
| Ready-to-Use Therapeutic Food | Dietary supplement | Ready-to-Use Therapeutic Food |
Primary outcome
Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects.
Time frame: 6 months
Acceptability, as determined by patient reported perceptions of nutritional support.
Time frame: 6 months
Costs of monthly nutritional support rations.
Time frame: 6 months
12 secondary outcomes
Tuberculosis treatment adherence as determined by Medication Possession Ratio
Time frame: 6 months
Tuberculosis treatment adherence as determined by patient reported number of missed doses in the previous 7 days and 4 weeks.
Time frame: 6 months
Tuberculosis treatment completion defined as completing full course of prescribed therapy
Time frame: 6 months
Adherence to antiretroviral therapy as determined by Medication Possession Ratio
Time frame: 6 months
Adherence to antiretroviral therapy as determined by patient reported number of missed doses in the previous 7 days and 4 weeks
Time frame: 6 months
CD4 cell count
Time frame: 6 months
Presence of acid fast bacteria using sputum smear microscopy
Time frame: 6 months
Results of GeneXpert
Time frame: 6 months
Nutritional status as determined by Body Mass Index
Time frame: 6 months
Nutritional status as determined by change in weight (kg)
Time frame: 6 months
Food security status measured using the Household Food Insecurity Access Scale (HFIAS)
Time frame: 6 months
Hemoglobin levels (g/dl)
Time frame: 6 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 18 Oct 2018.
- Derived from this study: PubMed 31318879Benzekri NA, Sambou JF, Tamba IT, Diatta JP, Sall I, Cisse O, Thiam M, Bassene G, Badji NM, Faye K, Sall F, Malomar JJ, Seydi M, Gottlieb GS. Nutrition support for HIV-TB co-infected adults in Senegal, West Africa: A randomized pilot implementation study. PLoS One. 2019 Jul 18;14(7):e0219118. doi: 10.1371/journal.pone.0219118. eCollection 2019.
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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.
Noelle A Benzekri, MD principal investigator
University of Washington
Moussa Seydi, MD principal investigator
La Clinique des Maladies Infectieuses, CHNU de Fann
Questions about this trial
What is this clinical trial studying?
A study testing Food basket and Ready-to-Use Therapeutic Food in people with HIV and Tuberculosis Co-infection, run by University of Washington.
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 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 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects. (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT03711721, which also lists 1 linked publication.
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 18 Oct 2018.