Kulindana: Community-friendly Delivery and Monitoring of... | NCT07628140

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

NCT07628140

Sponsor

University of Washington

Status

Not yet recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

1,500Estimated

Phase

Not Applicable

Conditions

Tuberculosis Prevention
HIV

Interventions

Differentiated service delivery (DSD) of TB preventive therapy (TPT)

Countries

Kenya

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AI183979-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Jul 2030Estimated

Completion Date

Jul 2031Estimated

First Submitted Date

May 29, 2026

First Submission Date that Met QC Criteria

May 29, 2026

First Posted Date

Jun 4, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2026

Last Update Posted Date

Jun 30, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adrienne E Shapiro, Assistant Professor in the Departments of Global Health and Medicine (Infectious Diseases), University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gillian O'Bryan	Contact	240-444-0098		gilliano@uw.edu
Adrienne Shapiro, MD, PhD	Contact			aeshapir@uw.edu

Overall Officials

Name	Affiliation	Role
Adrienne Shapiro, MD, PhD	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital		Kisumu			Kenya

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

A limited de-identified clinical dataset will be deposited in a public repository.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

The limited de-identified clinical dataset and supporting materials will be deposited in a public repository within one year of the end of the award period.

Access Criteria

The limited de-identified clinical dataset and supporting materials will be deposited in a public repository and publicly available; access to materials will be provided via request to the investigators through the repository and materials released after investigator approval.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided