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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL170926-01A1 | Other Grant/Funding Number | NIH |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Makerere University | OTHER |
| New York University | OTHER |
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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Navigation TB Education & Counseling (TB-EC) Strategy | Experimental |
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| Usual TB Education & Counseling (TB-EC) Strategy | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: TB Treatment Success | Defined according to criteria from the World Health Organization as either:
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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J. Lucian Davis, MD, MAS | Contact | 203-785-2912 | Lucian.Davis@yale.edu | |
| Achilles Katamba, MBChB, DCH, MS, PhD | Contact | amkatamba@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| J. Lucian Davis, MD, MAS | Yale University | Principal Investigator |
| Achilles Katamba, MBChB, DCH, MS, PhD | Makerere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walimu | Recruiting | Kampala | Uganda |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2026 | Mar 15, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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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.
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| 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. |
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| 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 |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |