NCT06883643|Completed
Adoption of Innovative Approaches to Ensure Continuity of Quality TB Services During COVID-19 Pandemic in Lusaka and Livingstone, Zambia. (Telemedicine in TB)
Telemed TB
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Telemed TB
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · U.S. Centers for Disease Control and Prevention's COVID-19 Response International Task Force
interventional
3,318
1 country
1
Study Start
February 4, 2022
Actual (reported)Primary Completion
March 31, 2023
Actual (reported)Study Completion
March 31, 2023
Actual (reported)Following the negative impact of public health program services including TB services by the COVID-19 Pandemic in 2020, CIDRZ conducted a program evaluation for remote patient follow up for TB treatment and prevention through a differentiated service delivery model (DSD), offering clinical monitoring and psychosocial support while minimizing contact with the health facilities. The project was implemented between February 2022 to March 2023 and was funded through Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding. While DSD models have been widely adopted in HIV programs , DSD is a relatively new and exciting approach for TB treatment and prevention programs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 4, 2022
Actual (reported)March 31, 2023
Actual (reported)March 31, 2023
Actual (reported)March 11, 2025
Actual (reported)March 19, 2025
Actual (reported)TB and TPT Outcomes
• The primary program evaluation outcomes of interest are the TPT and ATT completion rates in the prospective cohort, defined as the fraction of participants completing TPT or ATT among those who initiated TPT or ATT
12 months
Beginning February 2022, we offered ATT via 2-month MMD during intensive and 4-month MMD during continuation phases. In-clinic visits during 6-months of ATT were reduced from 7 under standard of care to 3 visits in DSD, while ensuring robust adherence and adverse event screening. Remote monitoring consisted of structured SMS (months 1 to 5) and phone (week 2 and month 3) follow-up to assess adherence and screen for side effects. If SMS were not returned, a phone or home visit was triggered.
Beginning February 2022, we offered TPT aligned to 6MMD ART model following standard of care processes with added support (See below). Remote monitoring consisted of structured SMS (months 1 to 5) and phone (week 2 and month 3) follow-up to assess adherence and screen for side effects. ROCs that did not respond to the SMS within 2 days were further contacted via phone and if not reachable a home visit was done. ROCs that reported at least one side effect or more were followed up with virtual reviews by clinicians. At enrollment ROCs reading language of preference was documented and the SMS was sent in their preferred language.
Although DSD models have been widely adopted in HIV programs, DSD is a relatively new approach for TB programs because of an historical reliance on directly observed therapy (DOT) (6). DSD provides opportunities to improve health outcomes and reduce the burden of seeking care for people diagnosed with TB.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Lusaka and Livingstone districts
Lusaka, Lusaka Province, 10101, Zambia
Mwanza Wa Mwanza, MD
Centre for Infectious Disease Research in Zambia
3,318 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2025
First Posted
March 19, 2025
Study Start
February 4, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 31, 2023
Actual (reported)Study Completion
March 31, 2023
Actual (reported)Last Updated
September 30, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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