Skip to content

Adoption of Innovative Approaches to Ensure Continuity of Quality TB Services During COVID-19 Pandemic in Lusaka and Livingstone, Zambia. (Telemedicine in TB)

Adoption of Innovative Approaches to Ensure Continuity of Quality TB Services During COVID-19 Pandemic in Lusaka and Livingstone, Zambia. (Telemedicine in TB)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06883643
Acronym
Telemed TB
Enrollment
3318
Registered
2025-03-19
Start date
2022-02-04
Completion date
2023-03-31
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus of the Study is to Evaluate DSD Models for Both TB Treatment and TPT Usiing Key Performance Indicators

Keywords

DSD TB

Brief summary

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.

Detailed description

During the COVID-19 pandemic, government restrictions on movement decreased access to health care. Although DSD models have been widely adopted in HIV programs, this is a relatively new approach for TB programs. Zambia's NTLP has already changed policy to allow for such adaptations of service delivery, but these adaptations are not universally implemented and have not been evaluated at this time. This project aims to evaluate these DSD models for both TB treatment (Anti-TB Treatment ATT) and TPT using standardized indicators. To complement these DSD models, innovative approaches like digital (texting/SMS and phone) treatment support and remote monitoring of adverse events will be adopted using bi-directional SMS through use of the rapid pro system, a tool that allows medical information to be gathered and shared via a cell phone. 1. To implement TPT in 6MMD and ATT DSD models at 5 sites in Lusaka and Livingstone districts 2. To assess acceptability of TPT in 6MMD and ATT DSD models at implementation sties 3. To assess trends in TPT coverage and completion rates from pre-implementation through implementation periods using aggregate program performance data 4. To assess trends in ATT completion rates from pre-implementation through implementation periods using aggregate program performance data 5. To inform the Ministry of Health on a systematic approach for digital follow up and screening for TB and TPT RoCs aligned to MMD models of care.

Interventions

BEHAVIORALDifferentiated service delivery approach (DSD) in TB treatment and prevention.

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.

Sponsors

Ministry of Health, Zambia
CollaboratorOTHER_GOV
Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding
CollaboratorUNKNOWN
Centre for Infectious Disease Research in Zambia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Project evaluation

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

TB ARM * All ROCs presenting to chest clinic for TB treatment between February 2022 and September 2022 were considered for inclusion if: Diagnosed with TB (new cases or retreatment cases) 18 years and above Willing and able to provide consent Not pregnant or breastfeeding No MDR TB TPT ARM All ROCs presenting to the ART clinic between February 2022 and September 2022 were considered for inclusion if they were: 18 years or above virally supressed with no symptoms or diagnosis suggestive of TB on ART for more than 6 months on 6MMD Consented to participate in the project did not receive TPT in the last 3 years not pregnant or breastfeeding women not incarcerated

Exclusion criteria

ATT ARM * RoCs those TB diagnosis is not confirmed * RoCs who are less than 18 years old * RoCs not able to provide consent for program evaluation participation * RoCs with MDR TB TPT ARM * RoCs with symptoms suggestive of TB, diagnosed or confirmed with TB diagnosis * RoCs who received TPT in the last 3 years * RoCs who are less than 18 years old * RoCs not able to provide consent for program evaluation participation * Pregnant and breastfeeding women * Incarcerated persons

Design outcomes

Primary

MeasureTime frameDescription
TB and TPT Outcomes12 months• 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

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026