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Kulindana: Expanding Access and Impact of Tuberculosis Preventative Therapy: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission

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

The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and people living with HIV (PWH). The main questions it aims to answer are: * Is community-based and multi-month dispensing of short-course TPT with minimal clinic and laboratory monitoring associated with higher rates of initiation and completion of TPT, compared to standard of care, in both HHC and PWH? * Does community-based and DSD TPT reduce household and community TB transmission? Researchers will compare DSD TPT delivery to standard of care (SoC) to see if DSD TPT delivery has an effect on TPT uptake and completion. Participants will: * Be assessed for TPT eligibility through either DSD TPT service delivery of SoC including differentiated TB screening procedures. * If eligible, receive DSD TPT service delivery or SoC TPT service delivery. * Over 12 weeks receive either DSD or SoC TPT adherence assessment and follow-up. * Have TPT completion assessed at 12 weeks following enrolment. * A subset of participants will be assess for TB incidence at 9 months following enrolment.

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

• Household contacts (HHC) are eligible for enrolment if the participant shares a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate).

• People living with HIV (PWH) are eligible for enrolment if the participant is an adult aged 15 and over, is eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.

Locations
Other Locations
Kenya
Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital
RECRUITING
Kisumu
Contact Information
Primary
Gillian O'Bryan
gilliano@uw.edu
240-444-0098
Backup
Adrienne Shapiro, MD, PhD
aeshapir@uw.edu
Time Frame
Start Date: 2026-07-14
Estimated Completion Date: 2031-07
Participants
Target number of participants: 1500
Treatments
Experimental: Differentiated service delivery (DSD) of TPT
In the household contact (HHC) population DSD TPT will be delivered at home in a single dispense of a full course of TPT; in the people living with HIV (PWH) population DSD TPT will be delivered at the clinic in a single dispense of a full course of TPT.
No_intervention: Clinic-based standard of care
Both the household contact (HHC) population and the people living with HIV (PWH) population have TPT dispensed at the clinic according to standard practice, typically one month at a time.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: University of Washington

This content was sourced from clinicaltrials.gov