Tuberculosis PreventionNCT07628140
Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission
A study testing Differentiated service delivery (DSD) of TB preventive therapy (TPT) in people with Tuberculosis Prevention and HIV, run by University of Washington at 1 site in Kenya.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis Prevention, HIV
- What is being tested?
- Differentiated service delivery (DSD) of TB preventive therapy (TPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteKenya
- Study dates
- 14 Jul 2026to Jul 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- HHC will be excluded if the participant plans on permanently relocating from the area within the next three months, is not willing to receive TPT screening and initiation at home, or is enrolled in any other investigational/interventional HIV or TB study.
- PWH will be excluded if the participant plans on permanently relocating from the area within the next three months, has contraindications for TPT according to the Kenyan National Guidelines, or is enrolled in any other investigational/interventional HIV or TB study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Adrienne Shapiro, MD, PhD contact
Kenya1 site, 1 recruiting
- Recruiting
Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital
Kisumu
Celestine Atieno, +254 713 053766, catien00@uw.edu
About this study
Official title: Kulindana: Expanding Access and Impact of Tuberculosis Preventative Therapy: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Tuberculosis Prevention, HIV
- Being tested
- Differentiated service delivery (DSD) of TB preventive therapy (TPT)
- Keywords
- tuberculosis, household contact, TB preventive therapy, 3HP, HIV, contact investigation, multi-month dispensing, differentiated service delivery
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Differentiated service delivery (DSD) of TPT | Experimental | 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. Receives: Other: Differentiated service delivery (DSD) of TB preventive therapy (TPT) |
| Clinic-based standard of care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB preventive therapy completion
Proportion of participants completing 11 out of 12 weeks of TPT within 16 weeks
Measured: 16 weeks
Secondary outcomes (1)
IGRA conversion
Proportion of child household contacts (age <15 years) who convert their IGRA result from negative to positive.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start14 Jul 2026
- Primary completionJul 2030 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis PreventionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrienne E Shapiro, University of Washington
- Investigators
- Adrienne Shapiro, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628140
- Sponsor's protocol ID
- STUDY00024388
- Other IDs
- R01AI183979-01A1
- Status last verified
- Aug 2026
- First submitted
- 29 May 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A limited de-identified clinical dataset will be deposited in a public repository.