HIV and Tuberculosis Co-infection
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFood basket
DIETARY_SUPPLEMENTReady-to-Use Therapeutic Food
Sponsors
La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Tuberculosis treatment adherence as determined by Medication Possession Ratio | 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 | — |
| Results of GeneXpert | 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 | — |
Outcome results
None listed