Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Peer-Navigaton TB-EC Strategy
BehavioralParticipants 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 Strategy
BehavioralParticipants 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.
Treatment groups
1,920 Participants
are divided into 2 treatment groupsGroup A: Peer Navigation TB Education & Counseling (TB-EC) StrategyExperimental treatment 1 intervention
Group B: Usual TB Education & Counseling (TB-EC) StrategyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness: TB Treatment Success
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.
Time frame
Up to 12 months after TB treatment initiation2
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.
Time frame
At month 6 after ART initiation (+/- 30 days)Secondary outcomes
1
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.
Time frame
At month 5 after TB treatment initiation, ±30 days2
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.
Time frame
At month 5 after TB treatment initiation, ±30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Makerere University
Collaborator
New York University
Collaborator
Source ClinicalTrials.gov