Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This five-year study will evaluate two strategies for conducting tuberculosis (TB) active case finding (ACF) and linkage to TB treatment or TB preventive therapy (TPT) in peri-urban Uganda. The two strategies differ in the location where ACF activities are performed: A facility-based ACF/TPT strategy will perform ACF, plus linkage to TPT, in the immediate vicinity of a large public health facility and will primarily recruit individuals who are attending the health facility, irrespective of TB suspicion or symptoms. Alternatively, a hotspot-based strategy will use routine notification data and local expertise to identify local TB hotspots - defined as the geographic areas though to have the highest burden of undiagnosed TB per estimated population. The same infrastructure (personnel, equipment, supplies, etc.) for ACF/TPT will then be placed in those zones for a period of four months at a time, and the general population will be recruited for screening and linkage to TPT. The two interventions will be compared in a Type 1 hybrid effectiveness-implementation trial with a cluster-randomized, multiple-period crossover design. The study will evaluate whether hotspot-focused ACF/TPT results in a greater number of TB patients diagnosed and linked to care, and a greater number of individuals started on preventive therapy, than facility-based ACF/TPT. Secondarily, it will also compare the two interventions in terms of number of people initiated on TPT, and it will compare TB cases detected in regions performing ACF/TPT (either approach) against cases detected in regions that continue to perform the standard of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: t
View:

• Age ≥15 years, OR age 5-14 and a close contact of someone diagnosed with TB,

• Provision of oral informed consent, or, if age \<18 years and not legally emancipated, oral informed assent (if ages 8-17) and parental informed consent (ages 5-17) to participate in the study

• Ability to communicate with study staff in English or Luganda, or availability of a capable interpreter who is acceptable to the participant

Locations
Other Locations
Uganda
Walimu
RECRUITING
Kampala
Contact Information
Primary
Emily A Kendall, MD PhD
ekendall@jhmi.edu
410-502-8234
Backup
David W Dowdy, MD PhD
ddowdy1@jhmi.edu
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 150000
Treatments
Experimental: Hotspot-focused ACF/TPT
ACF/TPT intervention will be delivered in a community setting, in geographic areas judged likely to have a high burden of undiagnosed TB
Experimental: Facility-based ACF/TPT
ACF/TPT intervention will be delivered on the grounds of a health facility (hospital or large public health center)
No_intervention: No intervention
Related Therapeutic Areas
Sponsors
Collaborators: Walimu, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov