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

Primary Purpose

HIV and Tuberculosis Co-infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Food basket
Ready-to-Use Therapeutic Food
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV and Tuberculosis Co-infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Food basket

    Ready-to-Use Therapeutic Food

    Arm Description

    Outcomes

    Primary Outcome Measures

    Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects.
    Acceptability, as determined by patient reported perceptions of nutritional support.
    Costs of monthly nutritional support rations.

    Secondary Outcome Measures

    Tuberculosis treatment adherence as determined by Medication Possession Ratio
    Tuberculosis treatment adherence as determined by patient reported number of missed doses in the previous 7 days and 4 weeks.
    Tuberculosis treatment completion defined as completing full course of prescribed therapy
    Adherence to antiretroviral therapy as determined by Medication Possession Ratio
    Adherence to antiretroviral therapy as determined by patient reported number of missed doses in the previous 7 days and 4 weeks
    CD4 cell count
    Presence of acid fast bacteria using sputum smear microscopy
    Results of GeneXpert
    Nutritional status as determined by Body Mass Index
    Nutritional status as determined by change in weight (kg)
    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.
    Hemoglobin levels (g/dl)

    Full Information

    First Posted
    October 8, 2018
    Last Updated
    October 17, 2018
    Sponsor
    University of Washington
    Collaborators
    La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03711721
    Brief Title
    Nutritional Support for HIV-Tuberculosis Co-infected Adults in Senegal, West Africa
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    August 2017 (Actual)
    Study Completion Date
    August 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV and Tuberculosis Co-infection

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Food basket
    Arm Type
    Experimental
    Arm Title
    Ready-to-Use Therapeutic Food
    Arm Type
    Experimental
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Food basket
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ready-to-Use Therapeutic Food
    Primary Outcome Measure Information:
    Title
    Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects.
    Time Frame
    6 months
    Title
    Acceptability, as determined by patient reported perceptions of nutritional support.
    Time Frame
    6 months
    Title
    Costs of monthly nutritional support rations.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Tuberculosis treatment adherence as determined by Medication Possession Ratio
    Time Frame
    6 months
    Title
    Tuberculosis treatment adherence as determined by patient reported number of missed doses in the previous 7 days and 4 weeks.
    Time Frame
    6 months
    Title
    Tuberculosis treatment completion defined as completing full course of prescribed therapy
    Time Frame
    6 months
    Title
    Adherence to antiretroviral therapy as determined by Medication Possession Ratio
    Time Frame
    6 months
    Title
    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
    Title
    CD4 cell count
    Time Frame
    6 months
    Title
    Presence of acid fast bacteria using sputum smear microscopy
    Time Frame
    6 months
    Title
    Results of GeneXpert
    Time Frame
    6 months
    Title
    Nutritional status as determined by Body Mass Index
    Time Frame
    6 months
    Title
    Nutritional status as determined by change in weight (kg)
    Time Frame
    6 months
    Title
    Food security status measured using the Household Food Insecurity Access Scale (HFIAS)
    Description
    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.
    Time Frame
    6 months
    Title
    Hemoglobin levels (g/dl)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Noelle A Benzekri, MD
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Moussa Seydi, MD
    Organizational Affiliation
    La Clinique des Maladies Infectieuses, CHNU de Fann
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31318879
    Citation
    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.
    Results Reference
    derived

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

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