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

NCT05917210 | Recruiting

• 2 other identifiers: 20000354161R01HL170926-01A1
• Study Type: interventional
• Target: 1,920
• Locations: 1 country
• Sites: 1

Brief 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

Tuberculosis; HIV

Keywords

tuberculosis; hiv; implementation science; Uganda; Yale; Makerere; New York University

Outcome Measures

Primary Outcomes (2)

• Effectiveness: TB Treatment Success

  Defined according to criteria from the World Health Organization as either: 1. Treatment completion - completion of TB treatment without evidence of treatment failure as documented in the on-site TB treatment register; or 2. Cure - among participants with microbiologically confirmed TB, a negative smear or culture result in the final month of treatment and on at least one previous occasion. The outcome will be assessed as the proportion of participants achieving TB treatment success based on program treatment records.

  Up to 12 months after TB treatment initiation

• Effectiveness: Antiretroviral Therapy (ART) Retention

  Among participants living with HIV and initiated on antiretroviral therapy (ART), ART retention will be defined as being (1) alive and (2) receiving ART, as evidenced by a documented ART medication pickup or documented ART supply at a clinical visit recorded in the on-site ART register or on the ART treatment card. The outcome will be assessed as the proportion of participants living with HIV who are alive and receiving ART at 6 months after ART initiation.

  At month 6 after ART initiation (+/- 30 days)

Secondary Outcomes (2)

• Implementation: TB Medication Adherence

  At month 5 after TB treatment initiation, ±30 days

• Implementation: ART Adherence

  At month 5 after TB treatment initiation, ±30 days

Study Arms (2)

Peer Navigation TB Education & Counseling (TB-EC) Strategy

EXPERIMENTAL

Behavioral: Peer-Navigaton TB-EC Strategy

Usual TB Education & Counseling (TB-EC) Strategy

ACTIVE COMPARATOR

Behavioral: Usual TB-EC Strategy

Interventions

Peer-Navigaton TB-EC Strategy BEHAVIORAL

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.

Peer Navigation TB Education & Counseling (TB-EC) Strategy

Usual TB-EC Strategy BEHAVIORAL

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.

Usual TB Education & Counseling (TB-EC) Strategy

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Registered as a new, relapse, treatment failure, or previously lost-to-follow-up
• TB case according to the on-site NTP TB Treatment Register
• Screened and invited to participate within 30 days of TB treatment initiation

You may not qualify if:

• Diagnosed with possible or confirmed drug-resistant TB
• Transferring TB care into the clinic from an off-site facility
• Residing \>40 km from the enrolling clinic
• Lacking mental capacity to provide informed consent

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• Makerere University: collaborator
• New York University: collaborator

Study Sites (1)

Walimu

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Tuberculosis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• J. Lucian Davis, MD, MAS

  Yale University

  PRINCIPAL INVESTIGATOR

• Achilles Katamba, MBChB, DCH, MS, PhD

  Makerere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J. Lucian Davis, MD, MAS

CONTACT

203-785-2912; Lucian.Davis@yale.edu

Achilles Katamba, MBChB, DCH, MS, PhD

CONTACT

amkatamba@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel, cluster-randomized trial with a hybrid Type 2 effectiveness-implementation design and staggered site initiation. Sites will be randomized using restricted randomization based on site volume, with volume-matched site pairs initiating enrollment at approximately the same time. Clusters will remain in their assigned study arm for the duration of the trial.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: March 16, 2026
• Primary Completion (Estimated): April 16, 2028
• Study Completion (Estimated): October 16, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

UG (1)