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| ID | Type | Description | Link |
|---|---|---|---|
| NU2GGH002251 | Other Grant/Funding Number | U.S. Centers for Disease Control and Prevention's COVID-19 Response International Task Force |
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| Name | Class |
|---|---|
| Ministry of Health, Zambia | OTHER_GOV |
| Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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
TPT ARM
RoCs with symptoms suggestive of TB, diagnosed or confirmed with TB diagnosis
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| Name | Affiliation | Role |
|---|---|---|
| Mwanza Wa Mwanza, MD | Centre for Infectious Disease Research in Zambia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lusaka and Livingstone districts | Lusaka | Lusaka Province | 10101 | Zambia |
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Project evaluation
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