HIV, Tuberculosis
Conditions
Keywords
tuberculosis, hiv, implementation science, Uganda, Yale, Makerere, New York University
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.
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.
Interventions
BEHAVIORALPeer-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.
BEHAVIORALUsual 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
Yale University
National Institutes of Health (NIH)
Makerere University
New York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: TB Treatment Success | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implementation: TB Medication Adherence | At month 5 after TB treatment initiation, ±30 days | 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. |
| Implementation: ART Adherence | At month 5 after TB treatment initiation, ±30 days | 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. |
Countries
Uganda
Contacts
CONTACTJ. Lucian Davis, MD, MAS
CONTACTAchilles Katamba, MBChB, DCH, MS, PhD
PRINCIPAL_INVESTIGATORJ. Lucian Davis, MD, MAS
Yale University
PRINCIPAL_INVESTIGATORAchilles Katamba, MBChB, DCH, MS, PhD
Makerere University
Outcome results
None listed