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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Tuberculosis
• Intervention / Treatment: Behavioral: Peer-Navigaton TB-EC Strategy; Behavioral: Usual TB-EC Strategy

Detailed Description

Study Design

Aim 1. The investigators will conduct a parallel, cluster-randomized, hybrid Type 2, effectiveness-implementation trial at 16 sites in Uganda.

This clinical trials registration focuses on Aim 1.

In addition, we will pursue two additional non-interventional aims to better understand the implementation and outcomes of Aim 1:

Aim 2. Within the Aim 1 study, the investigators will also perform a mediation analysis of social and behavioral factors (i.e., TB knowledge, perceived social support, general self-efficacy, HIV/TB stigma) to identify causal mechanisms of impact.

Aim 3. The investigators will conduct nested quantitaive, qualitative, and mixed methods studies to assess the implementation fidelity and context of the peer-navigation strategy for TB-EC, including the following sub-aims:

1. Surveys of peers and healthcare workers to determine the feasibility, acceptability, and appropriateness of the peer-navigation strategy,
2. Direct observations, document review, interviews with peers, and healthcare worker focus groups to characterize fidelity and adaptation of the peer navigation strategy,
3. Measures of implementation costs,
4. In-depth interviews with peer navigators to characterize their experiences,
5. Focus-group discussions (FGDs) with healthcare workers, and
6. In-depth interviews with people with tuberculosis (PWTB) to characterize their experiences.

• Study Type: Interventional
• Enrollment (Estimated): 1920
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Achilles Katamba, MBChB, DCH, MS, PhD; Email: amkatamba@gmail.com
• Study Contact Backup: Name: J. Lucian Davis, MD, MAS; Phone Number: 203-785-2912; Email: Lucian.Davis@yale.edu

Study Locations

• Uganda
  • Kampala, Uganda
    • Recruiting
    • Walimu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer Navigation TB Education & Counseling (TB-EC) Strategy	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.
Active Comparator: Usual TB Education & Counseling (TB-EC) Strategy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: TB Treatment Success	Defined according to criteria from the World Health Organization as either: Treatment completion - completion of TB treatment without evidence of treatment failure as documented in the on-site TB treatment register; or; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation: TB Medication Adherence	Assessed using point-of-care urine colorimetric testing for isoniazid metabolites, conducted by trained on-site research assistants. A positive urine test indicates recent ingestion of isoniazid and will be used as an objective measure of adherence to isoniazid-containing TB therapy. The outcome will be assessed as the proportion of participants with a positive urine test for isoniazid metabolites.	At month 5 after TB treatment initiation, ±30 days
Implementation: ART Adherence	Among participants living with HIV and initiated on antiretroviral therapy (ART), ART adherence will be assessed using point-of-care urine testing for tenofovir using an enzyme-linked immunosorbent assay (ELISA), conducted by trained on-site research assistants. A positive urine test indicates recent ingestion of tenofovir and will be used as an objective measure of adherence to tenofovir-containing ART. The outcome will be assessed as the proportion of participants living with HIV and initiated on ART with a positive urine tenofovir assay.	At month 5 after TB treatment initiation, ±30 days

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: New York University; National Institutes of Health (NIH); Makerere University
• Investigators: Principal Investigator: J. Lucian Davis, MD, MAS, Yale University; Principal Investigator: Achilles Katamba, MBChB, DCH, MS, PhD, Makerere University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): April 16, 2028
• Study Completion (Estimated): October 16, 2028

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: tuberculosis; hiv; Uganda; implementation science; Yale; Makerere; New York University
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; HIV Infections; Acquired Immunodeficiency Syndrome; Tuberculosis
• Other Study ID Numbers: 2000035416; 1R01HL170926-01A1 (Other Grant/Funding Number: NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data from this study will be made publicly available in a repository such as Yale Dataverse upon publication of the primary results. The dataset will include all variables used in the primary and secondary outcomes, and will be accompanied by the study protocol and a data dictionary to facilitate use.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No