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

Not Applicable

Completed

• Conditions: HIV and Tuberculosis Co-infection
• Interventions: Dietary Supplement: Ready-to-Use Therapeutic Food; Dietary Supplement: Food basket

• Registration Number: NCT03711721
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-10
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-17
• Study First Posted: 2018-10-18
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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

Read More

Exclusion Criteria

• Unwilling or unable to provide written informed consent

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ready-to-Use Therapeutic Food	Ready-to-Use Therapeutic Food	-
Food basket	Food basket	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)	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.
Hemoglobin levels (g/dl)	6 months
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