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

NCT07628140 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-06-30

No results posted yet for this study

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

  • Tuberculosis Prevention
  • HIV

Interventions

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, 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.

Sponsors & Collaborators

Principal Investigators

  • Adrienne Shapiro, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-07-31
Completion
2031-07-31

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628140 on ClinicalTrials.gov