HIV and Tuberculosis Co-infection Clinical Trial
Official title:
Nutritional Support to Improve Adherence and Treatment Completion Among HIV-Tuberculosis Co-infected Adults in Senegal, West Africa: A Randomized Pilot Implementation Study
| NCT number | NCT03711721 |
| Other study ID # | 20150056 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2016 |
| Est. completion date | August 2017 |
| Verified date | October 2018 |
| Source | University of Washington |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | August 2017 |
| Est. primary completion date | August 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington | La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects. | 6 months | ||
| Primary | Acceptability, as determined by patient reported perceptions of nutritional support. | 6 months | ||
| Primary | Costs of monthly nutritional support rations. | 6 months | ||
| Secondary | Tuberculosis treatment adherence as determined by Medication Possession Ratio | 6 months | ||
| Secondary | Tuberculosis treatment adherence as determined by patient reported number of missed doses in the previous 7 days and 4 weeks. | 6 months | ||
| Secondary | Tuberculosis treatment completion defined as completing full course of prescribed therapy | 6 months | ||
| Secondary | Adherence to antiretroviral therapy as determined by Medication Possession Ratio | 6 months | ||
| Secondary | Adherence to antiretroviral therapy as determined by patient reported number of missed doses in the previous 7 days and 4 weeks | 6 months | ||
| Secondary | CD4 cell count | 6 months | ||
| Secondary | Presence of acid fast bacteria using sputum smear microscopy | 6 months | ||
| Secondary | Results of GeneXpert | 6 months | ||
| Secondary | Nutritional status as determined by Body Mass Index | 6 months | ||
| Secondary | Nutritional status as determined by change in weight (kg) | 6 months | ||
| Secondary | 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 | |
| Secondary | Hemoglobin levels (g/dl) | 6 months |