Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission

Sponsor
University of Washington
Study ID
NCT07628140
Status
Not Yet Recruiting

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Conditions

  • HIV
  • Tuberculosis Prevention

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Differentiated service delivery (DSD) of TB preventive therapy (TPT) — OTHER
    TPT is normally provided at clinics with monthly visits for refills, but the full course of TPT can also be provided all at once through differentiated service delivery (DSD) of TPT. By doing the Kulindana study, the investigators hope to learn which way of delivering TPT to participants (through usual clinic practice, or all at once) is best for helping participants finish a full course of TPT.

Study Details

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.

Key Dates

First listed
Jun 4, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

TB preventive therapy completion [ Time Frame: 16 weeks ]

Central Contacts

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