DeMONSTRATE-TB Study in Ethiopia

Official title

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

Overview

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.

Interventions

• Combination product Enhanced community-wide TB intervention
  Interventions in the intervention arms consist of the following key components: 1. an optimized national recommended set of interventions; such as the implementation of all types of contact investigation, targeted TB screening and diagnosis at key affected population, and optimized HIV screening and TPT for PLHIV; 2. intensive, active, and community-based HH screening and diagnosis of TB using combined TB screening (clinical and X-ray) and X-pert MTB/RIF, as indicated; 3. community-based enhanc
• Combination product Routine TB program activities
  In the control arm, the standard of care will continue per the national guideline.

Primary outcome measures

• Population-level TB prevalence [Time frame: Semi-annual screening (up to 2 years)]

Secondary outcome measures (1)

• Change in TB treatment outcomes [Time frame: Baseline and at 2 years]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• Adults:

• Does not provide consent
• Declines to provide contact information
• Less than 18 years
• Living outside of the study site area
• Declines to allow study staff to contact them by phone and in person if they miss a study visit
• Children

• Does not provide assent
• Guardian does not provide consent
• Guardian declines to provide contact information
• Not within 12 to 17 years
• Living outside of the study site area
• Guardian declines to allow study staff to contact them by phone and in person if they miss a study visit
• Younger Children

• Guardian does not provide consent
• Guardian declines to provide contact information
• Not less than 12 years
• Living outside of the study site area
• Guardian declines to allow study staff to contact them by phone and in person if they miss a study visit

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Prevention

Study locations

Ethiopia · 2 centers

• Gedebe Hassassa woreda — West Arsi Zone
• Boloso Bombe woreda — Wolayita Zone

Identifiers

NCT: NCT06719193 · 37.2022 · 72066320CA00009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗