Demonstrating Multipronged and Optimized Novel Strategies to Reinforce Actions Targeted At Eliminating Tuberculosis (DeMONSTRATE-TB): a Sequential Exploratory Mixed Method Study in Ethiopia

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Ending the TB epidemic by 2035 in Ethiopia would be possible if TB notification declines by an annual factor of at least 15% from the current notification rate of 132 per 100,000 population. This requires highly effective strategies to reduce TB transmission and maximize TB prevention among populations at risk of developing TB, such as Household contacts and people living with HIV. The investigators hypothesize that community wide administration of enhanced TPT will accelerate decline in TB incidence rates when combined with an optimized currently recommended comprehensive TB prevention and care packages described below. The investigators further hypothesize that such intervention packages will be acceptable to the community, providers and policy makers, and that they will be cost-effective. Based on the study results, a TB elimination framework in high burden TB regions and woredas in Ethiopia will be developed, and local evidence to enhance the shift toward TB elimination will be provided as input to the appropriate allocation of resources.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• Adults:

‣ Greater than or equal to 18 years old

⁃ Provides consent

⁃ Living in study site area (woreda)

• Children

‣ Aged 12 to 17 years

⁃ Living in the study site area (woreda)

⁃ Assent to enrollment

⁃ Guardian provides consent for enrollment

• Younger children:

‣ Less than 12 years old

⁃ Living in the study site area (woreda)

⁃ Consent for enrollment provided by the guardian

Locations
Other Locations
Ethiopia
Gedebe Hassassa woreda
RECRUITING
West Arsi Zone
Boloso Bombe woreda
RECRUITING
Wolayita Zone
Contact Information
Primary
Oumer Ali, PhD
oumer.ali@kncvtbc.org
617-250-9500
Backup
Zewdu Dememew, MD, PhD
zgashu@msh.org
617-250-9500
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 131438
Treatments
Experimental: Enhanced community-wide TB intervention
Enhanced community-wide TB intervention strategy with intensive screening and health education
Active_comparator: Routine TB program activities
TB standard of care per Ethiopia's national guidelines
Related Therapeutic Areas
Sponsors
Collaborators: KNCV Tuberculosis Foundation
Leads: Management Sciences for Health

This content was sourced from clinicaltrials.gov