The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TB
Abstract Background Clinical trials evaluating new regimens for multidrug-resistant tuberculosis (MDR-TB) are typically conducted in multiple countries because global registration of new TB drugs requires evaluation in diverse populations. The complexity of multi-site trials makes implementation cha...
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BMC
2025-05-01
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| Online Access: | https://doi.org/10.1186/s13063-025-08887-7 |
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| author | Bazarragchaa Tsogt Meera Gurumurthy Elisa Giallongo Karen Sanders Ganzorig Munkhjargal Zayakhuu Khukhuukhen Enkhjin Bolormaa Enkhtuvshin Raash Naranbat Nyamdavaa Gay Bronson |
| author_facet | Bazarragchaa Tsogt Meera Gurumurthy Elisa Giallongo Karen Sanders Ganzorig Munkhjargal Zayakhuu Khukhuukhen Enkhjin Bolormaa Enkhtuvshin Raash Naranbat Nyamdavaa Gay Bronson |
| author_sort | Bazarragchaa Tsogt |
| collection | DOAJ |
| description | Abstract Background Clinical trials evaluating new regimens for multidrug-resistant tuberculosis (MDR-TB) are typically conducted in multiple countries because global registration of new TB drugs requires evaluation in diverse populations. The complexity of multi-site trials makes implementation challenging, especially in lower-resource settings, where the burden of MDR-TB is highest. Stakeholder engagement can improve trial implementation and outcomes. Here, we describe the Mongolia site’s stakeholder engagement during STREAM, a phase III clinical trial evaluating novel treatment regimens for MDR-TB. Main body We assessed our stakeholder engagement against the PCORI rubric. Engagement at all phases of the trial aligned well with the PCORI engagement principles of reciprocal relationships; co-learning; building partnerships; and transparency, honesty, and trust. In the planning phase, we formed a key partnership with a civil society organization to co-lead the trial, undertook stakeholder mapping, and developed an overall engagement strategy. During trial implementation, we undertook activities aimed at ensuring feasibility of the study, improving recruitment, ensuring viability of the study, and ensuring authenticity/value of stakeholder engagement. Activities, which included continuous communication with the national TB program to ensure referral of potential trial participants, implementation of a comprehensive community engagement (CE) program, delivery in collaboration with partners of psychosocial support for trial participants, capacity-building and knowledge sharing, regular communications on trial developments and progress, and community advisory board (CAB) participation in CE assessment, contributed to achieving a 98% retention rate and the highest participant recruitment across all STREAM trial sites. In the dissemination phase, CAB members worked together with the site and sponsor to ensure strategies and materials were tailored to stakeholders’ needs, including participants; communities; frontline healthworkers; and national-level stakeholders. Stakeholder participation in research and in improving routine TB care in the country has been sustained since completion of the trial. Conclusions Significant and sustainable gains can be made through stakeholder collaboration. We recommend that trial sites in lower-resourced settings take an expansive view of relevant stakeholders when planning engagement; undertake capacity-building and knowledge sharing; plan for long-term sustainability of CE; design engagement around specific objectives; tailor and optimize communication strategies; and design stakeholder engagement to involve key policy makers. Trial registration ISRCTN78372190 - Registration date is October 14, 2010 (Stage 1) and ISRCTN18148631 - Registration date is February 10, 2016 (Stage 2). |
| format | Article |
| id | doaj-art-2d21124a91da448ca3eed8b653b142de |
| institution | DOAJ |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-2d21124a91da448ca3eed8b653b142de2025-08-20T03:16:34ZengBMCTrials1745-62152025-05-0126112410.1186/s13063-025-08887-7The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TBBazarragchaa Tsogt0Meera Gurumurthy1Elisa Giallongo2Karen Sanders3Ganzorig Munkhjargal4Zayakhuu Khukhuukhen5Enkhjin Bolormaa6Enkhtuvshin Raash7Naranbat Nyamdavaa8Gay Bronson9National Center for Communicable DiseasesVital Strategies Health Systems, Asia PacificMedical Research Council Clinical Trials Unit at UCLMedical Research Council Clinical Trials Unit at UCLMongolian Anti-TB CoalitionNational Center for Communicable DiseasesCommunity Advisory BoardCommunity Advisory BoardMongolian Anti-TB CoalitionVital StrategiesAbstract Background Clinical trials evaluating new regimens for multidrug-resistant tuberculosis (MDR-TB) are typically conducted in multiple countries because global registration of new TB drugs requires evaluation in diverse populations. The complexity of multi-site trials makes implementation challenging, especially in lower-resource settings, where the burden of MDR-TB is highest. Stakeholder engagement can improve trial implementation and outcomes. Here, we describe the Mongolia site’s stakeholder engagement during STREAM, a phase III clinical trial evaluating novel treatment regimens for MDR-TB. Main body We assessed our stakeholder engagement against the PCORI rubric. Engagement at all phases of the trial aligned well with the PCORI engagement principles of reciprocal relationships; co-learning; building partnerships; and transparency, honesty, and trust. In the planning phase, we formed a key partnership with a civil society organization to co-lead the trial, undertook stakeholder mapping, and developed an overall engagement strategy. During trial implementation, we undertook activities aimed at ensuring feasibility of the study, improving recruitment, ensuring viability of the study, and ensuring authenticity/value of stakeholder engagement. Activities, which included continuous communication with the national TB program to ensure referral of potential trial participants, implementation of a comprehensive community engagement (CE) program, delivery in collaboration with partners of psychosocial support for trial participants, capacity-building and knowledge sharing, regular communications on trial developments and progress, and community advisory board (CAB) participation in CE assessment, contributed to achieving a 98% retention rate and the highest participant recruitment across all STREAM trial sites. In the dissemination phase, CAB members worked together with the site and sponsor to ensure strategies and materials were tailored to stakeholders’ needs, including participants; communities; frontline healthworkers; and national-level stakeholders. Stakeholder participation in research and in improving routine TB care in the country has been sustained since completion of the trial. Conclusions Significant and sustainable gains can be made through stakeholder collaboration. We recommend that trial sites in lower-resourced settings take an expansive view of relevant stakeholders when planning engagement; undertake capacity-building and knowledge sharing; plan for long-term sustainability of CE; design engagement around specific objectives; tailor and optimize communication strategies; and design stakeholder engagement to involve key policy makers. Trial registration ISRCTN78372190 - Registration date is October 14, 2010 (Stage 1) and ISRCTN18148631 - Registration date is February 10, 2016 (Stage 2). https://doi.org/10.1186/s13063-025-08887-7Clinical TrialsTuberculosisStakeholder engagementCommunity engagementMongolia |
| spellingShingle | Bazarragchaa Tsogt Meera Gurumurthy Elisa Giallongo Karen Sanders Ganzorig Munkhjargal Zayakhuu Khukhuukhen Enkhjin Bolormaa Enkhtuvshin Raash Naranbat Nyamdavaa Gay Bronson The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TB Trials Clinical Trials Tuberculosis Stakeholder engagement Community engagement Mongolia |
| title | The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TB |
| title_full | The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TB |
| title_fullStr | The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TB |
| title_full_unstemmed | The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TB |
| title_short | The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TB |
| title_sort | role of stakeholder mapping and engagement in mongolia during the implementation of the stream clinical trial for mdr tb |
| topic | Clinical Trials Tuberculosis Stakeholder engagement Community engagement Mongolia |
| url | https://doi.org/10.1186/s13063-025-08887-7 |
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