Walimu
Kampala, Uganda
Location status: Recruiting
Location contact
Achilles Katamba
CONTACT
256-414-530-021,
Achilles Katamba, MBChB PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05285202
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.
Interested in participating?
Request Info5 year and older
All sexes
Interventional
Not applicable
Kampala, Uganda
Location status: Recruiting
Achilles Katamba
CONTACT
256-414-530-021,
Achilles Katamba, MBChB PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ACF/TPT in both intervention arms will consist of TB screening by mobile chest X-ray (with artificial intelligence-based reading, followed by confirmatory sputum testing with Xpert MTB/RIF Ultra for participants with abnormal x-rays), and linkage to preventive therapy for those who are TB-negative and eligible for TPT (limited in April 2024 to those with close TB contact or known HIV infection).
Time frame: From the start to two weeks after the end of each four-month intervention period
Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing periods in which regions performed hotspot-focused ACF/TPT to those in which facility-based ACF/TPT was performed.
Time frame: From the start to two weeks after the end of each four-month intervention period
Number of study region residents initiating TPT during intervention periods, comparing periods in which regions performed hotspot-focused ACF/TPT to those in which facility-based ACF/TPT was performed.
Time frame: 48 months from start of interventions in each "triplet" of clusters
Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing intervention regions to control regions.
Time frame: Approximately 38 to 46 months per cluster (5 to 6 four-month intervention periods, plus intervening washout periods)
Trend in TB notification rate over the span of study intervention involvement, comparing intervention clusters to control clusters
Time frame: From the start to two weeks after the end of each four-month intervention period
Number of people diagnosed with TB through study participation and initiating treatment for TB, hotspot-focused and facility-based ACF/TPT.
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Total number of people screened for TB with each intervention.
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Number of study participants found to have Xpert-positive sputum.
Time frame: From the start to two weeks after the end of each four-month intervention period
Incremental cost per disability-adjusted life year (DALY) averted, comparing the more to the less effective ACF/TPT intervention (if an effectiveness difference is found).
Time frame: From the start to two weeks after the end of each four-month intervention period
Incremental cost per disability-adjusted life year (DALY) averted, comparing ACF/TPT to no ACF/TPT.
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Total number of people completing TST placement and reading by the study
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Number of participants referred for TB preventive therapy based on TST result or other eligibility criteria
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Number of people screened for TB who are identified as contacts of a person diagnosed with TB through the study
Contact information is provided by the study sponsor or research team.
David W Dowdy, MD PhD
CONTACT
Emily A Kendall, MD PhD
CONTACT
Johns Hopkins University
Other
Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial
Acronym: CHASE-TB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04493671
Actinomycetales Infections, Bacterial Infections
San Antonio, Texas, United States
View Trial DetailsNCT05526911
Actinomycetales Infections, Bacterial Infections
Fair Lawn, New Jersey, United States
View Trial DetailsNCT06441006
Actinomycetales Infections, Bacterial Infections
Ulaanbaatar, Mongolia
View Trial DetailsNCT06253715
Actinomycetales Infections, Bacterial Infections
Chennai, India
View Trial Details