GCP Course for Pharmacists

This week, TREAT TB launched an online Good Clinical Practice (GCP) course for pharmacists.  The course was developed for pharmacists involved in the STREAM Clinical Trial to build their capacity  in clinical research. Jan Komrska, the STREAM pharmacist highlighted that “Traditional GCP trainings consist of basic courses aimed at physicians and nurses involved in clinical trials.  In contrast, the TREAT TB/STREAM course is an interactive web based tool specifically tailored to the pharmacists involved in STREAM  to enhance their understanding of the critical role they play in the delivery of patient care to STREAM participants. It focuses on management and accountability of trial drugs.”

The course is accessible here and would be a useful tool for any pharmacist involved in clinical research.

STREAM Stage 2 is the result of a unique collaboration between USAID, Janssen Pharmaceuticals and The Union/Vital Strategies.

STREAM Uganda Commences Community Engagement Activities

The Uganda STREAM site in Kampala will start enrolling patients very shortly!  In keeping with the trial’s commitment to civil society participation in the trial, the STREAM team had its initial meeting  with community stakeholders,  even prior to enrolling the first patient. Dr. Conradie, an investigator with many years of experience with HIV and TB research, travelled to the Kampala site on the 12th and 13th of July to begin the process.   She commented that “On the first day of the visit, I met with most of the staff from the site. After presenting the rationale for community engagement, the site staff members did role plays to practice various scenarios for communicating about STREAM, including a mock radio show, a presentation to the Ministry of Health and then a more casual chat to people in ordinary social situations. This was a great way to practice effective communication, as it mirrors  engagement with all key stakeholders. We laughed and learned at the same time.”

On 13th July, community members attended a planning meeting with the aim of establishing a community advisory board (CAB) and planning its work. “I was very impressed at the broad range of people attending the meeting. Over 30 delegates participated, including members of the TB directorate, TB program managers, a chaplain, doctors and nurses from other sites, and most poignantly four people who had survived MDR-TB. I was struck yet again by the courage required to simply survive MDR-TB treatment. One young man stated that he would not wish MDR-TB on his worst enemy. Another talked about the stigma of MDR-TB in the community and how people backed away from him when they found out about his diagnosis, even after he had been cured. At the end of the meeting, Dr. Ivan Kimuli, the site's community liaison officer asked for volunteers to continue working on community engagement for STREAM, and there was an encouraging response,” said Dr. Conradie.  A CAB was formed, and enthusiastic participants from the meeting will be working to define its upcoming activities.
 

Focus on Zero Interruption in the Standard Short Treatment Regimen

TREAT TB concluded its first week of a 2-week technical assistance (TA) visit in the Philippines on July 21, 2017. The TA visit includes a total of eight (8) facility visits in three regions (Regions V, VI, and VII) and two (2) regional workshops (Regions V and VI) where the standard short treatment regimen (SSTR) is now being implemented.

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TREAT TB, USAID, the Philippines National TB Program (NTP), and partners, are united in their goal to achieve zero treatment interruption among patients with MDR-TB enrolled in the SSTR. Beginning with this end in mind, the team met with key implementers and managers in the regional facilities to understand the programmatic and clinical strengths of implementation of the SSTR to date. The goal was to identify and address challenges, particularly those related to adverse drug reactions, training, supervision, and monitoring and evaluation. The team also sought to strengthen buy-in at the regional level for the implementation of proposed responses and strategies needed to improve program outcomes at the national, regional, and local levels, including development of regional TB medical advisory committees (TB MAC) which will provide clinical management expertise to physicians and nurses.

This week, the team successfully conducted six (6) site visits in Regions VI and VII. One of the highlights of the first week was the Region VI workshop, which was well-attended by regional staff, facility physicians and nurses, and provincial and city health officials, and resulted in the creation of the TB MAC to improve MDR-TB outcomes.

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STREAM starts screening patients in Europe

On July 11, the first patient in Europe was screened for Stage 2 of the STREAM trial in Moldova. 

Although the country’s population is  only ~3 million, over 500 new MDR-TB cases were registered in 2016. Given the high burden of disease in the country,  Moldova was identified as a logical location for implementing the STREAM trial. The national TB referral and research hospital – Institute of Phthisiopneumology “Chiril Draganiuc” – in Chisinau quickly expressed strong interest in leading the trial in Moldova and has meticulously completed all preparations required to initiate screening.

Dr. Elena Tudor, principal investigator for STREAM in Moldova, has high hopes for improving treatment outcomes for her patients: “I would be pleased if my country could improve its current treatment success rate for MDR-TB patients which is [currently] at 57.1% and get closer to the success rate reported from Bangladesh with an approximate 80% success rate.”

Dr. Elena Tudor in front of the Institute of Phthisiopneumology “Chiril Draganiuc” in Chisinau, Moldova.

Dr. Elena Tudor in front of the Institute of Phthisiopneumology “Chiril Draganiuc” in Chisinau, Moldova.

STREAM Stage 2 is the result of a unique collaboration between USAID, Janssen Pharmaceuticals and The Union/Vital Strategies.  The STREAM team is proud to welcome the experienced study team from Moldova to the STREAM trial.

STREAM Staff at South Africa STREAM Stage 2 Sites

Soo Chung, a subcontracts manager at Vital Strategies, was recently in South Africa for a monitoring visit.  Soo oversees the contracts and budgeting for all STREAM sites and she visits sites regularly to monitor spending and compliance with USAID regulations. During her recent South Africa visit, Soo had the opportunity to speak with members of the study team at the Johannesburg site (Helen Joseph Hospital) and the Pietermaritzburg site (Doris Goodwin Hospital).

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Soo spoke with Michael, who is the Health and Safety Officer and drives patients with MDR-TB to the STREAM site at in Johannesburg for their appointments.  Michael meets with government officials on a quarterly basis to ensure that proper infection control procedures are followed at the Clinical Health Research Unit at the Wits Health Consortium, which oversees the trial in Johannesburg and DurbanHe also ensures that the STREAM vehicle is clean and sanitized, often starting his day an hour before his scheduled start time to make sure the job is done well.

Michael shared that, "[STREAM] is important because recently South Africa has been realizing...what research is. There are people who don't receive the treatment they need since it's too expensive for people in economically disadvantaged groups. The trial helps the sick people receive professional treatment that they wouldn't be able to afford on their own."

Soo also discussed trial progress with Samantha Aucock, the STREAM trial coordinator at Pietermaritzburg, and members of the finance/operations teams at Wits.  Samantha ensures the site provides care according to the STREAM protocol and organizational standards, and actively oversees coordination and collaboration with the trial sponsor and stakeholders.  Ina de Jongh and Simone Thomson (pictured here) are the General Manager of Operations and Divisional Grants Manager, respectively, at Wits Health Consortium. Ina works on contracts setup, budget approvals, and report approvals and Simone creates financial reports and oversees compliance with USAID regulations.

Samantha explained that "While South Africa has the highest TB burden per population size in the world, the HIV/TB burden is one of the leading causes of death in the country.  This has devastating effects on the individuals, communities, and society at large. Shorter, less toxic and easy-to-take treatment could ensure improved outcomes and higher treatment adherence, benefiting patients and easing the burden on the health sector."