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

NCT06883643 | Completed

• 2 other identifiers: Telemedicine in TBNU2GGH002251
• Study Type: interventional
• Target: 3,318
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

DSD TB

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TB treatment ARM

ACTIVE COMPARATOR

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.

Behavioral: Differentiated service delivery approach (DSD) in TB treatment and prevention.

TPT DSD

ACTIVE COMPARATOR

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.

Behavioral: Differentiated service delivery approach (DSD) in TB treatment and prevention.

Interventions

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

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.

TB treatment ARM; TPT DSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TB ARM
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• Ministry of Health, Zambia: collaborator
• Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding: collaborator

Study Sites (1)

Lusaka and Livingstone districts

Lusaka, Lusaka Province, 10101, Zambia

Location

Related Links

• Differentiated Service Delivery

Study Officials

• Mwanza Wa Mwanza, MD

  Centre for Infectious Disease Research in Zambia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Project evaluation

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 19, 2025
• Study Start: February 4, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: March 19, 2025

Record last verified: 2025-01

Locations

ZA (1)