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

NCT07628140 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00024388R01AI183979-01A1
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Tuberculosis Prevention

Keywords

tuberculosis; household contact; TB preventive therapy; 3HP; HIV; contact investigation; multi-month dispensing; differentiated service delivery

Outcome Measures

Primary Outcomes (1)

• TB preventive therapy completion

  Proportion of participants completing 11 out of 12 weeks of TPT within 16 weeks

  16 weeks

Secondary Outcomes (1)

• IGRA conversion

  9 months

Study Arms (2)

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

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.

Differentiated service delivery (DSD) of TPT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital

Kisumu, Kenya

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Adrienne Shapiro, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gillian O'Bryan

CONTACT

240-444-0098; gilliano@uw.edu

Adrienne Shapiro, MD, PhD

CONTACT

aeshapir@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in the Departments of Global Health and Medicine (Infectious Diseases)

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

KE (1)