Clinical trial NCT06883643: Adoption of Innovative Approaches to Ensure Continuity of Quality TB Services During COVID-19 Pandemic in Lusaka and Livingstone, Zambia. (Telemedicine in TB)
Official title: Adoption of Innovative Approaches to Ensure Continuity of Quality TB Services During COVID-19 Pandemic in Lusaka and Livingstone, Zambia. (Telemedicine in TB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of the Study is to Evaluate DSD Models for Both TB Treatment and TPT Usiing Key Performance Indicators
Keywords: DSD TB
Lead sponsor: Centre for Infectious Disease Research in Zambia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Zambia
name: Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding
First posted: 2025-03-19
Enrollment: 3318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Project evaluation
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: TB and TPT Outcomes
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Lusaka and Livingstone districts
Study officials:
affiliation: Centre for Infectious Disease Research in Zambia
name: Mwanza Wa Mwanza, MD
role: STUDY_DIRECTOR
References: