TuberculosisTEACHNCT05917210
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
A study testing Peer-Navigaton TB-EC Strategy and Usual TB-EC Strategy in people with Tuberculosis and HIV, run by Yale University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, HIV
- What is being tested?
- Peer-Navigaton TB-EC Strategy and Usual TB-EC Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,920 participants
- Where
- 1 siteUganda
- Study dates
- 16 Mar 2026to 16 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Achilles Katamba, MBChB, DCH, MS, PhD contact
About this study
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.
Read the 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:
- Surveys of peers and healthcare workers to determine the feasibility, acceptability, and appropriateness of the peer-navigation strategy,
- Direct observations, document review, interviews with peers, and healthcare worker focus groups to characterize fidelity and adaptation of the peer navigation strategy,
- Measures of implementation costs,
- In-depth interviews with peer navigators to characterize their experiences,
- Focus-group discussions (FGDs) with healthcare workers, and
- In-depth interviews with people with tuberculosis (PWTB) to characterize their experiences.
- Conditions
- Tuberculosis, HIV
- Being tested
- Peer-Navigaton TB-EC Strategy, Usual TB-EC Strategy
- Keywords
- tuberculosis, hiv, implementation science, Uganda, Yale, Makerere, New York University
- Medical subject headings
- Tuberculosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Navigaton TB-EC StrategyBehavioural
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.
Usual TB-EC StrategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer Navigation TB Education & Counseling (TB-EC) Strategy | Experimental | Not described Receives: Behavioral: Peer-Navigaton TB-EC Strategy |
| Usual TB Education & Counseling (TB-EC) Strategy | Active comparator | Not described Receives: Behavioral: Usual TB-EC Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At month 6 after ART initiation (+/- 30 days)
Secondary outcomes (2)
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.
Measured: 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.
Measured: At month 5 after TB treatment initiation, ±30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start16 Mar 2026
- Primary completion16 Apr 2028 (estimated)
- Study completion16 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Makerere University, New York University
- Responsible party
- Sponsor
- Investigators
- J. Lucian Davis, MD, MAS, Principal investigator, Yale UniversityAchilles Katamba, MBChB, DCH, MS, PhD, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917210
- Sponsor's protocol ID
- 2000035416
- Other IDs
- 1R01HL170926-01A1
- Acronym
- TEACH
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
- ClinicalTrials.gov ID
- NCT05917210
- Acronym / sponsor ID
- TEACH / 2000035416
- Conditions
- Tuberculosis, HIV
- Keywords
- tuberculosis, hiv, implementation science, Uganda, Yale, Makerere, New York University
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,920 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Makerere University, New York University
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 16 Apr 2028 (estimated)
- Study completion
- 16 Oct 2028 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Surveys of peers and healthcare workers to determine the feasibility, acceptability, and appropriateness of the peer-navigation strategy,
- Direct observations, document review, interviews with peers, and healthcare worker focus groups to characterize fidelity and adaptation of the peer navigation strategy,
- Measures of implementation costs,
- In-depth interviews with peer navigators to characterize their experiences,
- Focus-group discussions (FGDs) with healthcare workers, and
- In-depth interviews with people with tuberculosis (PWTB) to characterize their experiences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-Navigaton TB-EC StrategyParticipants 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. | Behavioural | Peer Navigation TB Education & Counseling (TB-EC) Strategy |
| Usual TB-EC StrategyParticipants 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. | Behavioural | Usual TB Education & Counseling (TB-EC) Strategy |
Primary outcome
Effectiveness: TB Treatment Success
Time frame: Up to 12 months after TB treatment initiation
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.
Effectiveness: Antiretroviral Therapy (ART) Retention
Time frame: At month 6 after ART initiation (+/- 30 days)
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.
2 secondary outcomes
Implementation: TB Medication Adherence
Time frame: At month 5 after TB treatment initiation, ±30 days
Implementation: ART Adherence
Time frame: At month 5 after TB treatment initiation, ±30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Achilles Katamba, MBChB, DCH, MS, PhD contact
J. Lucian Davis, MD, MAS principal investigator
Yale University
Achilles Katamba, MBChB, DCH, MS, PhD principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Navigaton TB-EC Strategy and Usual TB-EC Strategy in people with Tuberculosis and HIV, run by Yale University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J. Lucian Davis, MD, MAS (203-785-2912, Lucian.Davis@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: TB Treatment Success (time frame: Up to 12 months after TB treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.