Focus of the Study is to Evaluate DSD Models for Both TB Treatment and TPT Usiing Key Performance IndicatorsTelemed TBNCT06883643
Adoption of Innovative Approaches to Ensure Continuity of Quality TB Services During COVID-19 Pandemic in Lusaka and Livingstone, Zambia. (Telemedicine in TB)
A study testing Differentiated service delivery approach (DSD) in TB treatment and prevention. in people with Focus of the Study is to Evaluate DSD Models for Both TB Treatment and TPT Usiing Key Performance Indicators, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focus of the Study is to Evaluate DSD Models for Both TB Treatment and TPT Usiing Key Performance Indicators
- What is being tested?
- Differentiated service delivery approach (DSD) in TB treatment and prevention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,318 participants
- Where
- 1 siteZambia
- Study dates
- 4 Feb 2022to 31 Mar 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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.
- Being tested
- Differentiated service delivery approach (DSD) in TB treatment and prevention.
- Keywords
- DSD TB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differentiated service delivery approach (DSD) in TB treatment and prevention.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Differentiated service delivery approach (DSD) in TB treatment and prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start4 Feb 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study is to Evaluate DSD Models for Both TB Treatment and TPT Usiing Key Performance IndicatorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Project evaluation
- Masking
- None (open label)
- Enrolment
- 3,318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Zambia
- Responsible party
- Sponsor
- Investigators
- Mwanza Wa Mwanza, MD, Study director, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883643
- Sponsor's protocol ID
- Telemedicine in TB
- Other IDs
- NU2GGH002251
- Acronym
- Telemed TB
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided