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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

The effectiveness of a self-stigma reduction intervention upon stigma measures for patients with TB and MDR-TB in Vietnam: a randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000949189
Acronym
VStigma-C
Enrollment
122
Registered
2019-07-05
Start date
2020-03-18
Completion date
2021-01-29
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Significance: Self-stigma harms patients’ psychosocial wellbeing, creating barriers to their effective treatment and recovery from disease. Objectives: This study aims to evaluate the effectiveness of a self-stigma workshop upon stigma, treatment outcomes, psychological wellbeing, depression, self-efficacy and self-compassion for patients with new TB and RR/MDR-TB in Vietnam. Methods: We will perform a randomised controlled trial in Hanoi province of Vietnam. Patients with RR/MDR-TB and new TB will be randomly allocated to the intervention or control arm. The intervention group will participate in a self-stigma workshop titled ‘From the inside out’. The workshop consists of eight modules run one day per week for four weeks. The control group will receive a 30 TB transmission and treatment presentation (included in the intervention arm). All study participants will self-administer a questionnaire at baseline, after two months and after four months. The questionnaire will comprise validated scales to measure stigma, treatment adherence, psychological wellbeing, depression and self-efficacy. Hypothesis: reduction of self-stigma in the intervention arm by greater than or equal to 10% when compared to the control arm. The mean scores for the included scales will be compared between the control and intervention groups of the patients with TB and MDR-TB separately.

Interventions

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:

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Unable to participate in the intervention People that are incarcerated Do not live in the study location, Hanoi, Vietnam

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026