Clinical trial NCT03711721: Nutritional Support for HIV-Tuberculosis Co-infected Adults in Senegal, West Africa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV and Tuberculosis Co-infection
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: La Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire de Fann
First posted: 2018-10-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Uptake, as determined by percent of monthly nutritional support rations received, transported, stored, and utilized by subjects.
timeFrame: 6 months
measure: Acceptability, as determined by patient reported perceptions of nutritional support.
timeFrame: 6 months
measure: Costs of monthly nutritional support rations.
timeFrame: 6 months
Secondary outcomes:
measure: Tuberculosis treatment adherence as determined by Medication Possession Ratio
timeFrame: 6 months
measure: Tuberculosis treatment adherence as determined by patient reported number of missed doses in the previous 7 days and 4 weeks.
timeFrame: 6 months
measure: Tuberculosis treatment completion defined as completing full course of prescribed therapy
timeFrame: 6 months
measure: Adherence to antiretroviral therapy as determined by Medication Possession Ratio
timeFrame: 6 months
measure: Adherence to antiretroviral therapy as determined by patient reported number of missed doses in the previous 7 days and 4 weeks
timeFrame: 6 months
measure: CD4 cell count
timeFrame: 6 months
measure: Presence of acid fast bacteria using sputum smear microscopy
timeFrame: 6 months
measure: Results of GeneXpert
timeFrame: 6 months
measure: Nutritional status as determined by Body Mass Index
timeFrame: 6 months
measure: Nutritional status as determined by change in weight (kg)
timeFrame: 6 months
measure: Food security status measured using the Household Food Insecurity Access Scale (HFIAS)
timeFrame: 6 months
measure: Hemoglobin levels (g/dl)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Noelle A Benzekri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Clinique des Maladies Infectieuses, CHNU de Fann
name: Moussa Seydi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.