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

NCT ID: NCT03711721

Last Updated: 2018-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV and Tuberculosis Co-infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Food basket

Group Type EXPERIMENTAL

Food basket

Intervention Type DIETARY_SUPPLEMENT

Ready-to-Use Therapeutic Food

Group Type EXPERIMENTAL

Ready-to-Use Therapeutic Food

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Food basket

Intervention Type DIETARY_SUPPLEMENT

Ready-to-Use Therapeutic Food

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann

UNKNOWN

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Noelle Benzekri

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noelle A Benzekri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Moussa Seydi, MD

Role: PRINCIPAL_INVESTIGATOR

La Clinique des Maladies Infectieuses, CHNU de Fann

References

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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.

Reference Type DERIVED
PMID: 31318879 (View on PubMed)

Other Identifiers

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20150056

Identifier Type: -

Identifier Source: org_study_id

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