Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peer-Navigaton TB-EC Strategy, Usual TB-EC Strategy.
- Who it may be relevant to
- Registry conditions: Tuberculosis, HIV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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. - 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.
Primary outcome measures
- Effectiveness: TB Treatment Success [Time frame: Up to 12 months after TB treatment initiation]
- Effectiveness: Antiretroviral Therapy (ART) Retention [Time frame: At month 6 after ART initiation (+/- 30 days)]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Uganda · 1 center
- Walimu — Kampala
Identifiers
NCT: NCT05917210 · 2000035416 · 1R01HL170926-01A1