An interventional study of Differentiated service delivery (DSD) of TB preventive therapy (TPT) in Tuberculosis Prevention and HIV, sponsored by University of Washington. Recruiting at 1 site in Kenya. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by University of Washington · Not applicable, Interventional, and Other
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:
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:
The investigators will conduct a two-arm, non-blinded, randomized controlled trial (RCT) comparing differentiated TPT delivery to standard of care (SOC) clinic-based TPT. The central hypothesis is that decentralized, differentiated-service delivery approaches to TPT will improve TPT uptake and completion in Kenya. This study will be conducted in seven HIV clinics in Kisumu County, a high HIV/TB burden region in western Kenya. This study has two populations:
(A) Household contacts (HHC) of Index TB patients (Index patients: any age, diagnosed with pulmonary TB (or any TB if \<18 years), who live with at least one other person not currently taking TB treatment). The TB index patients and household contacts include children.
(B) People living with HIV (PWH), aged 15+ who are eligible for TPT per Kenyan guidelines.
The primary outcome, 3 months after enrollment, is completion of a course of TPT, defined as taking 11 weeks of TPT within 16 weeks.
Exclusion Criteria:
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.
Other: Differentiated service delivery (DSD) of TB preventive therapy (TPT)
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.
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.
TB preventive therapy completion
Proportion of participants completing 11 out of 12 weeks of TPT within 16 weeks
Time frame: 16 weeks
IGRA conversion
Proportion of child household contacts (age \<15 years) who convert their IGRA result from negative to positive.
Time frame: 9 months
Plan to share: Yes — A limited de-identified clinical dataset will be deposited in a public repository.
Supporting information: Study protocol, Sap
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