Table 2.

Stakeholder engagement during the initiation/planning phase for STREAM clinical trial

Stakeholder	Engagement activities/approach	Communications activities	Barriers addressed by engagement activities	Impact of engagement
The Global Fund to Fight AIDS, Tuberculosis and Malaria; WHO country office	Activities: Site met with the project coordinating unit (PCU) of GFATM and a WHO officer, jointly with NTP, to introduce the trial and to clarify sponsor’s responsibility for procuring interventional drugs Strategic insights: Meeting was important for ensuring continuity of international support for NTP and resource alignment. Helped ensure NTP and PCU incorporated trial’s expected drug procurement into GFATM’s procurement plans for the NTP	Timing: Five months prior to Site Initiation Mode: In-person meeting Frequency: Once Written materials used (if any): Introductory slides outlining the trial and associated implementation activities	Financial and human capacity constraints Lack of favorable research environment	GFATM support for Mongolian NTP (primarily funded by the GFATM) reinforced and continued
MoHa	Activities: Initial meeting with MoH to present the trial, introduce the site team, provide site-specific details and management of the trial at the site, and gather immediate feedback on the implementation of the trial. This meeting has also clarified details of information and documents required for import/export of samples, equipment and supplies Follow-on comms to better-define ethical and regulatory requirements for the trial, as well as to agree form and content of required agreements Site translated key trial documents from English to Mongolian for review by MoH Strategic insights: Engagement helped ensure MoH’s buy-in for the trial and facilitated site obtaining permission to export biological samples and import interventional drugs	Timing: Four months prior to Site Initiation Mode: Initial in-person meetings/follow on emails Frequency: Bi-weekly during the first month Written materials used (if any): Introductory slides outlining the trial and associated implementation activities	Ethical and regulatory system obstacles Lack of favorable research environment Operational barriers	High level of MoH buy-in for the trial Reduction of time to site opening Development of “work around” to allow export of microbiology samples to trial’s central laboratory in Belgium In principle permission to import trial drugs
NTP at the NCCD	Activities: Initial meeting with NTP manager to explain trial objectives and requirements, potential benefits to the NTP Follow on meeting with NTP managers to define a model of collaboration for the trial, including identification of suitable trial team members, identification and referral of participants to the trial, NTP support for DOT/patient management, etc. Meeting with MDR-TB clinicians to explain trial objectives and requirements, potential benefits to the NTP Site visit to National Reference TB lab, TB Pharmacy unit, and two MDR-TB wards to assess possible physical infrastructure improvements required for trial, approaches for integrating the trial activities and effective information flow and communications Strategic insights: Engagement led to adoption of a critical collaboration strategy with the NTP involving the sharing of scarce human resources by the trial and the NTP	Timing: Four to five months prior to Site Initiation Mode: In-person meetings/emails/phone Frequency: Five times Written materials used (if any): Trial summary	Financial and human capacity constraints Operational barriers Competing demands	High level of national buy-in for the trial Improved capacity of NTP staff to contribute to research Model developed for collaboration between NTP and future multi-site research studies High recruitment rate to the trial High retention rate for the trial, facilitated by NTP support for DOT/patient management Trial did not divert scarce human resources from NTP Good collaboration between government and non-government organizations
Frontline health workers at district TB dispensaries	Activities: Site, NTP leaders and sponsor met with TB dispensary coordinators and main clinicians responsible for patient management at 9 UB TB dispensaries to explain trial objectives and requirements, to discuss the trial’s potential benefits to participants and the NTP, and to obtain support for the trial from frontline health workers; followed by Q&A Site coordinator met with TB dispensary coordinators and main clinicians responsible for patient management at 9 UB TB dispensaries to understand patient referral mechanisms, DOT and patient management Site and district TB dispensaries defined roles/responsibilities related to all aspects of the trial Strategic insights: Engagement was important for providing TB dispensaries with clarity on trial processes and clearly defining roles/responsibilities of the site and TB dispensaries for the trial. Also helped strengthen communications between TB dispensaries and trial team	Timing: Four to five months prior to Site Initiation Mode: In-person meetings Frequency: Twice Written materials used (if any): Introductory slides outlining the trial and associated implementation activities	Financial and human capacity constraints Lack of favorable research environment Operational barriers Competing demands	High referral and recruitment rates to the trial High retention rate for the trial Reduced number of protocol deviations Improved capacity of frontline health workers to participate in clinical trials Trust and support built between the trial team and frontline health workers
NTRL	Activities: In-person initial meeting with NTRL to explain trial objectives and lab requirements, ensuring clarity on key tasks In-person technical meeting with the head of the NTRL addressed technical requirements of trial-specific procedures and regulatory requirements for sample exportation Site translated trial lab manual from English to Mongolian for review by NTRL senior staff Strategic insights:	Timing: Two to three months prior to Site Initiation Mode: In-person meetings/emails Frequency: Twice; follow up emails Written materials used (if any): Trial protocol	Financial and human capacity constraints Lack of favorable research environment Operational barriers	Trial lab assessments performed successfully as per protocol requirements Improved technical capacity of the NTRL and staff at NTRL Established successful model for future collaboration between national reference lab/programmatic lab and multi-site clinical research studies
NCCD directors/management	Activities: Meetings with NCCD General Director to provide an overview of the trial and its implementation, as well as discussion of trial team members Meeting with NCCD’s Deputy Directors and head of finance focused on legal agreements and financial matters Site translated key trial documents from English to Mongolian for review by directors/management of NCCD Strategic insights: Engagement was important for building high-level buy in and ensuring the trial was properly funded by Sponsor	Timing: Four to six months prior to Site Initiation Mode: In-person Frequency: Three times Written materials used (if any): Trial summary	Financial and human capacity constraints Competing demands	High-level buy-in for the trial at NCCD All required NCCD trial staff identified and in place in two months Clear time and effort allocations between trial and NTP activities for NCCD staff agreed and implemented
NCCD Scientific Committee (SC)	Activities: Initial in-person meeting with the SC scientific secretary held to gain a clear understanding of the SC’s application requirements Second in-person meeting with SC member in order to review the trial protocol and related documents, and address questions to ensure compliance with SC regulations Site translated key trial documents from English to Mongolian for review Strategic insights: Early engagement important so that any important concerns of SC could be identified and (if necessary) fed back to the Sponsor	Timing: Six months prior to Site Initiation Mode: In-person/phone/emails Frequency: Twice Written materials used (if any): Introductory slides outlining the trial and associated implementation activities	Lack of favorable research environment Operational barriers	High level of scientific buy-in for the trial Reduction of time to site opening
CSOs	Activities: Coordinated by MTC, site met with treatment support volunteers/community health workers from the Mongolian Anti-TB Association to gather valuable insights on how to best support MDR-TB patients Strategic insights: Engagement led to development of supplemental participant support package that contributed to better trial outcomes. Also gave site access to volunteers/community health workers, which helped to ensure treatment adherence.	Timing: Two months prior to and four months after Site Initiation Mode: In-person Frequency: Twice Written materials used (if any):	Operational barriers Competing demands	High retention rate for the trial, facilitated by CSO’s home DOT and psychosocial support for trial participant and their families CSO helped ensure participants attended trial specific follow-up visits and were referred for unscheduled visits, when necessary Model of collaboration between CSOs and study teams for future TB clinical research defined
CAB	n/a, not yet formed
People affected by MDR-TB	Activities: Site developed/completed a short survey (self-administered by Px; managed by senior nurses in twoTB wards) of 50+ MDR-TB patients to understand their experience of MDR-TB and identify their needs for support during treatment and follow up Strategic insights: Survey results provided crucial insights that helped to inform the development of a targeted patient support strategy for the trial	Timing: One month prior to Site Initiation Mode: In-person Frequency: Once Written materials used (if any): A summary outlining the purpose of the survey, a verbal consent script, and an anonymous, self-administered questionnaire	Operational barriers	Based on survey results, targeted patient support strategy developed and implemented, with the aim to improve recruitment and retention

^aIncluding Department of Health Care and Services, Medical Ethics Monitoring Committee, and Center for Health Development