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Trial registered on ANZCTR


Registration number
ACTRN12619000949189
Ethics application status
Approved
Date submitted
13/06/2019
Date registered
5/07/2019
Date last updated
5/07/2019
Date data sharing statement initially provided
5/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of a self-stigma reduction intervention upon stigma measures for patients with tuberculosis (TB) and multidrug-resistant tuberculosis (MDR-TB) in Vietnam: a randomised controlled trial
Scientific title
The effectiveness of a self-stigma reduction intervention upon stigma measures for patients with TB and MDR-TB in Vietnam: a randomised controlled trial
Secondary ID [1] 298349 0
None
Universal Trial Number (UTN)
U1111-1234-2305
Trial acronym
VStigma-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stigma 312999 0
depression 313000 0
tuberculosis 313001 0
multidrug-resistant tuberculosis 313002 0
Condition category
Condition code
Infection 311503 311503 0 0
Other infectious diseases
Mental Health 311504 311504 0 0
Depression
Public Health 311505 311505 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A four-day workshop titled "from the inside out". The workshop was designed specifically for people with TB and MDR-TB. It has eight modules where the participants learn about self-stigma and self-shame, how to address these issues and change the way they think through interactive exercises, case studies, educational games, reflective writing and group work.
• Module 1: What is self-stigma? An introduction to the concept of self-stigma. (~ 4 hours)
• Module 2: Dealing with self-stigma and shame: Explores self-stigma and shame, enabling participants to learn how to identify and cope with their thoughts and feelings. (~12 hours)
• Module 3: DR-TB: Explores the impact of DR-TB on self-stigma. (~2 hours)
• Module 4: Transmission control and self-stigma: Self-stigma in the context
of transmission control. (~ 4 hours)
• Module 5: Health rights, TB, and self-stigma. (~4 hours)
• Module 6: Treatment: Linkage between treatment for TB and self-stigma. (~2 hours)
• Module 7: Planning for the future: TB Free! What now? (~2 hours)
• Module 8: Evaluation of self-stigma and its impact. (~2 hours)

The workshops will be run one 8 hour day per week over 3 or 4 weeks. The duration of each activity will be documented in the first adaptation workshop, and then we will know whether we will need the fourth day or if it is possible to complete all of the modules over three days.

Coverage will be recorded by the researchers using an attendance sheet for the participants at the start of the day and after lunch. At the end of the workshop, the participants will have a score ranging from 1-8 for attendance, where 1 would indicate a half day. If they do not attend, the researcher will contact them to ask them to join another session. Participation will be recorded twice a day. Together, the two researchers will discuss the extent of each participant's participation in the workshop. They will give them a score from 0-1, where 0 would indicate did not participate at all, did not contribute to the discussion or join activities, 0.5 half participates, sometimes joined in, sometimes did not and 1 would indicate full participation, they were involved in all activities and completed all tasks required. Both attendance and participation scores will be added up separately over the four days to give a total score ranging from 0 to 8 each. Where 6 or greater would indicate excellent participation and attendance, less than 6 ( less than 75%) is not acceptable attendance. For participation, 4-6 is good, 2-4 is poor, and less than 2 would indicate no participation.
Intervention code [1] 314589 0
Behaviour
Intervention code [2] 314863 0
Treatment: Other
Intervention code [3] 314864 0
Prevention
Comparator / control treatment
The control group will receive a 30-minute presentation on TB treatment and transmission. This will be a combined powerpoint from module 4: transmission control and module 6: treatment for TB (module 3 for patients with MDR-TB).
Control group
Active

Outcomes
Primary outcome [1] 320212 0
Evaluate the effect of a self-stigma and shame workshop (the intervention) upon the self-stigma of patients with RR/MDR-TB, measured according to a validated self-stigma scale (the Redwood self-stigma subscale).
Timepoint [1] 320212 0
4 months after baseline. The intervention will be delivered between baseline and 2 months.
Primary outcome [2] 320213 0
Evaluate the effect of the intervention upon the measured stigma of patients with new TB, measured according to a validated self-stigma scale (the Redwood self-stigma subscale).
Timepoint [2] 320213 0
4 months after baseline. The intervention will be delivered between baseline and 2 months.
Secondary outcome [1] 370865 0
Evaluate the effect of the intervention upon stigma, according to the Redwood MDR-TB for patients with RR/MDR-TB.
Timepoint [1] 370865 0
4 months after baseline. The intervention will be delivered between baseline and 2 months.
Secondary outcome [2] 370866 0
Evaluate the effect of the intervention on stigma, according to the Van Rie TB stigma scale, among patients with TB.
Timepoint [2] 370866 0
4 months after baseline. The intervention will be delivered between baseline and 2 months.
Secondary outcome [3] 370867 0
Evaluate the effect of the intervention upon treatment success (treatment cure and treatment completion) according to the programmatic outcome data from the national TB program.
Timepoint [3] 370867 0
End of TB treatment, Each individual TB and MDR-TB treatment regime varies in length. Typically, patients with TB will complete treatment in 6-8 months. Patients with MDR-TB can complete treatment in 9-10 months for the short regime, or 20-22 months for the long regime and more resistant strains of TB.
Secondary outcome [4] 370868 0
Evaluate the effect of the intervention upon depression, using the Patient Health Questionnaire (PHQ-9).
Timepoint [4] 370868 0
4 months after baseline.. The intervention will be delivered between baseline and 2 months.
Secondary outcome [5] 370869 0
Evaluate the effect of the intervention upon self-efficacy, according to Patient Activation Measure (PAM-13).
Timepoint [5] 370869 0
4 months after baseline. The intervention will be delivered between baseline and 2 months.
Secondary outcome [6] 370870 0
Evaluate the effect of the intervention upon self-compassion, according to Neff self-compassion scale – short version (12 items).
Timepoint [6] 370870 0
4 months after baseline. The intervention will be delivered between baseline and 2 months.
Secondary outcome [7] 370871 0
Evaluate the effect of the intervention upon psychological wellbeing, according to Ryff Psychological Wellbeing Scale
Timepoint [7] 370871 0
4 months after baseline. The intervention will be delivered between baseline and 2 months.

Eligibility
Key inclusion criteria
Patients with bacteriologically proven pulmonary TB and Patients with bacteriologically proven pulmonary RR/MDR-TB, be undertaking treatment for within the NTP at the participating health facilities and be considered as non-infectious will be eligible to participate. To be considered as non-infectious, they require 1) reduction in symptoms AND, 2) reduction in smear grade, culture negative for last 4 weeks OR unable to produce sputum AND 3) completed at least 2 weeks of treatment for patients with TB or 6 weeks of treatment for patients with RR/MDR-TB.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to participate in the intervention
People that are incarcerated
Do not live in the study location, Hanoi, Vietnam

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomised by computer. Concealed from recruiters.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A previous study demonstrated that a psychosocial stigma intervention reduced the average TB stigma score by 14.25% between the control and intervention groups. Using a conservative approach, we hypothesise a minimum difference of 10% between the control and the intervention group. In our previous study, we measured stigma in the same population and found the data were are normally distributed. Therefore, we used a two-sample t-test with a power of 80% and a 95% significance level. Using the data from our previous study, (standard deviation=14.5577 for patients with MDR-TB and 7.291 for patients with TB),

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2019
Actual
Date of last participant enrolment
Anticipated
16/12/2019
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
268
Accrual to date
Final
Recruitment outside Australia
Country [1] 21531 0
Viet Nam
State/province [1] 21531 0
Hanoi

Funding & Sponsors
Funding source category [1] 302886 0
University
Name [1] 302886 0
University of Sydney: Research Support Woolcock-Vietnam Initiative (DVCR-719)
Country [1] 302886 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 302841 0
Charities/Societies/Foundations
Name [1] 302841 0
Woolcock Institute of Medical Research
Address [1] 302841 0
431 Glebe Point Rd, Glebe NSW 2037
Country [1] 302841 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303461 0
University of Sydney: Human Research Ethics Committees
Ethics committee address [1] 303461 0
Ethics committee country [1] 303461 0
Australia
Date submitted for ethics approval [1] 303461 0
29/04/2019
Approval date [1] 303461 0
13/06/2019
Ethics approval number [1] 303461 0
2019/384
Ethics committee name [2] 303465 0
Vietnam Ministry of Health Institutional Review Board
Ethics committee address [2] 303465 0
Ethics committee country [2] 303465 0
Viet Nam
Date submitted for ethics approval [2] 303465 0
21/05/2019
Approval date [2] 303465 0
Ethics approval number [2] 303465 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93738 0
A/Prof Greg Fox
Address 93738 0
Rm 5216, Level 2 Medical Foundation Building K25
92-94 Parramatta Road | The University of Sydney | NSW | 2006
Country 93738 0
Australia
Phone 93738 0
+61 2 9036 3121
Fax 93738 0
Email 93738 0
greg.fox@sydney.edu.au
Contact person for public queries
Name 93739 0
Greg Fox
Address 93739 0
Rm 5216, Level 2 Medical Foundation Building K25
92-94 Parramatta Road | The University of Sydney | NSW | 2006
Country 93739 0
Australia
Phone 93739 0
+61 2 9036 3121
Fax 93739 0
Email 93739 0
greg.fox@sydney.edu.au
Contact person for scientific queries
Name 93740 0
Greg Fox
Address 93740 0
Rm 5216, Level 2 Medical Foundation Building K25
92-94 Parramatta Road | The University of Sydney | NSW | 2006
Country 93740 0
Australia
Phone 93740 0
+61 2 9036 3121
Fax 93740 0
Email 93740 0
greg.fox@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2201Study protocol    377670-(Uploaded-13-06-2019-15-06-26)-Study-related document.docx
2347Ethical approval    377670-(Uploaded-13-06-2019-15-06-03)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.