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Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda

NCT05917210 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1920

Last updated 2026-03-20

No results posted yet for this study

Summary

This cluster-randomized trial in Uganda will evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects.

Conditions

Interventions

BEHAVIORAL

Peer-Navigaton TB-EC Strategy

Participants receive a peer-navigation strategy for TB education and counseling, including individual-level components such as peer navigator support, an illustrated TB-EC booklet with checklist, individualized adherence planning, and behavior-change messaging; and clinic-level components such as task-sharing with peer navigators, workflow restructuring, community of practice meetings, and implementation champions to support delivery.

BEHAVIORAL

Usual TB-EC Strategy

Participants receive usual TB education and counseling delivered by healthcare workers, including individual-level components such as TB-HIV education using a flipchart and use of treatment supporters; and clinic-level components such as routine TB-EC delivery by healthcare workers.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Makerere University

    collaborator OTHER

  • New York University

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • J. Lucian Davis, MD, MAS · Yale University

  • Achilles Katamba, MBChB, DCH, MS, PhD · Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2028-04-16
Completion
2028-10-16

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

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 NCT05917210 on ClinicalTrials.gov