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

May 29, 2026 updated by: Adrienne E Shapiro, University of Washington

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

We will conduct a two-arm, non-blinded, randomized controlled trial (RCT) comparing differentiated TPT delivery to standard of care (SOC) clinic-based TPT. Our 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.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Kenya
      • Kisumu, Kenya
        • Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Household contacts (HHC) are eligible for enrolment if they share 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 they are adults aged 15 and over, are eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.

Exclusion Criteria:

  • HHC will be excluded if they plan on permanently relocating from the area within the next three months, are not willing to receive TPT screening and initiation at home, or are enrolled in any other investigational/interventional HIV or TB study.
  • PWH will be excluded if they plan on permanently relocated from the area within the next three months, have contraindications for TPT according to the Kenyan National Guidelines, or are enrolled in any other investigational/interventional HIV or TB study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Differentiated service delivery (DSD) of TB preventive therapy (TPT)
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, we hope to learn which way of delivering TPT to clients (through usual clinic practice, or all at once) is best for helping people finish their 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TB preventive therapy completion
Time Frame: 16 weeks
Proportion of participants completing 11 out of 12 weeks of TPT within 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGRA conversion
Time Frame: 9 months
Proportion of child household contacts (age <15 years) who convert their IGRA result from negative to positive.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Adrienne Shapiro, MD, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00024388
  • R01AI183979-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A limited de-identified clinical dataset will be deposited in a public repository by the end of the study award period.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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