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OpenTrials
Completed

NCT Number: NCT06883643

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lusaka and Livingstone districts

Lusaka, Lusaka Province, 10101, Zambia

About this study

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.

  • To implement TPT in 6MMD and ATT DSD models at 5 sites in Lusaka and Livingstone districts
  • To assess acceptability of TPT in 6MMD and ATT DSD models at implementation sties
  • To assess trends in TPT coverage and completion rates from pre-implementation through implementation periods using aggregate program performance data
  • To assess trends in ATT completion rates from pre-implementation through implementation periods using aggregate program performance data
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. TB and TPT Outcomes

    Time frame: 12 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

Sponsors and collaborators

Lead sponsor

Centre for Infectious Disease Research in Zambia

Other

Collaborators

  • Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding
  • Ministry of Health, Zambia

Registry information

Acronym: Telemed TB

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.