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

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.

Study Overview

• Status: Completed
• Conditions: HIV and Tuberculosis Co-infection
• Intervention / Treatment: Dietary supplement: Food basket; Dietary supplement: Ready-to-Use Therapeutic Food

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Food basket	Dietary supplement: Food basket
Experimental: Ready-to-Use Therapeutic Food	Dietary supplement: Ready-to-Use Therapeutic Food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects.	6 months
Acceptability, as determined by patient reported perceptions of nutritional support.	6 months
Costs of monthly nutritional support rations.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tuberculosis treatment adherence as determined by Medication Possession Ratio		6 months
Tuberculosis treatment adherence as determined by patient reported number of missed doses in the previous 7 days and 4 weeks.		6 months
Tuberculosis treatment completion defined as completing full course of prescribed therapy		6 months
Adherence to antiretroviral therapy as determined by Medication Possession Ratio		6 months
Adherence to antiretroviral therapy as determined by patient reported number of missed doses in the previous 7 days and 4 weeks		6 months
CD4 cell count		6 months
Presence of acid fast bacteria using sputum smear microscopy		6 months
Results of GeneXpert		6 months
Nutritional status as determined by Body Mass Index		6 months
Nutritional status as determined by change in weight (kg)		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.	6 months
Hemoglobin levels (g/dl)		6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann
• Investigators: Principal Investigator: Noelle A Benzekri, MD, University of Washington; Principal Investigator: Moussa Seydi, MD, La Clinique des Maladies Infectieuses, CHNU de Fann

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Coinfection
• Other Study ID Numbers: 20150056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No