NCT03711721

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

October 8, 2018

Last Update Submit

October 17, 2018

Conditions

HIV and Tuberculosis Co-infection

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

Food basket

EXPERIMENTAL
Dietary Supplement: Food basket

Ready-to-Use Therapeutic Food

EXPERIMENTAL
Dietary Supplement: Ready-to-Use Therapeutic Food

Interventions

Food basketDIETARY_SUPPLEMENT
Food basket
Ready-to-Use Therapeutic FoodDIETARY_SUPPLEMENT
Ready-to-Use Therapeutic Food

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unwilling or unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31318879DERIVED

Study Officials

  • Noelle A Benzekri, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Moussa Seydi, MD

    La Clinique des Maladies Infectieuses, CHNU de Fann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 18, 2018

Study Start

June 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 18, 2018

Record last verified: 2018-10