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Nutritional Support for HIV-Tuberculosis Co-infected Adults in Senegal, West Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711721
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann
Information provided by (Responsible Party):
Noelle Benzekri, University of Washington

Brief 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. 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.

Condition or disease Intervention/treatment Phase
HIV and Tuberculosis Co-infection Dietary Supplement: Food basket Dietary Supplement: Ready-to-Use Therapeutic Food Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : June 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Food basket Dietary Supplement: Food basket
Experimental: Ready-to-Use Therapeutic Food Dietary Supplement: Ready-to-Use Therapeutic Food



Primary Outcome Measures :
  1. Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects. [ Time Frame: 6 months ]
  2. Acceptability, as determined by patient reported perceptions of nutritional support. [ Time Frame: 6 months ]
  3. Costs of monthly nutritional support rations. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Tuberculosis treatment adherence as determined by Medication Possession Ratio [ Time Frame: 6 months ]
  2. Tuberculosis treatment adherence as determined by patient reported number of missed doses in the previous 7 days and 4 weeks. [ Time Frame: 6 months ]
  3. Tuberculosis treatment completion defined as completing full course of prescribed therapy [ Time Frame: 6 months ]
  4. Adherence to antiretroviral therapy as determined by Medication Possession Ratio [ Time Frame: 6 months ]
  5. 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 ]
  6. CD4 cell count [ Time Frame: 6 months ]
  7. Presence of acid fast bacteria using sputum smear microscopy [ Time Frame: 6 months ]
  8. Results of GeneXpert [ Time Frame: 6 months ]
  9. Nutritional status as determined by Body Mass Index [ Time Frame: 6 months ]
  10. Nutritional status as determined by change in weight (kg) [ Time Frame: 6 months ]
  11. Food security status measured using the Household Food Insecurity Access Scale (HFIAS) [ Time Frame: 6 months ]
    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.

  12. Hemoglobin levels (g/dl) [ Time Frame: 6 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
Criteria

Inclusion Criteria:

  • HIV-Tuberculosis co-infection
  • Age ≥18 years
  • Initiating treatment for tuberculosis
  • Provide written informed consent

Exclusion Criteria:

• Unwilling or unable to provide written informed consent


Information from the National Library of Medicine

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): NCT03711721


Sponsors and Collaborators
University of Washington
La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann
Investigators
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Principal Investigator: Noelle A Benzekri, MD University of Washington
Principal Investigator: Moussa Seydi, MD La Clinique des Maladies Infectieuses, CHNU de Fann
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Noelle Benzekri, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT03711721    
Other Study ID Numbers: 20150056
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Coinfection
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Infection
Virus Diseases
Parasitic Diseases