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

Study Overview
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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.

Official Title
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Nutritional Support to Improve Adherence and Treatment Completion Among HIV-Tuberculosis Co-infected Adults in Senegal, West Africa: A Randomized Pilot Implementation Study

Conditions
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HIV and Tuberculosis Co-infection

Intervention / Treatment
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* Dietary Supplement: Food basket
* Dietary Supplement: Ready-to-Use Therapeutic Food


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food basket<br> | Dietary Supplement: Food basket<br> <br> |
| Experimental: Ready-to-Use Therapeutic Food<br> | Dietary Supplement: Ready-to-Use Therapeutic Food<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |