- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05126225
Buddhist Understanding and Reduction of Myanmar Experiences of HIV Stigma and Exclusion (BURMESE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project is to explore how Myanmar People Living With HIV (PLWH) experience and manage HIV stigma as inspired by Buddhist teaching, and to adapt an evidence-based stigma-reduction intervention to tailor treatment for the unique needs of Myanmar People Living With HIV.
A stigma-reduction intervention will be adopted to the needs of Myanmar People Living With HIV with six focus groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- HIV-Positive
- Care by Myanmar Positive Group/CMRU
- Living in Myanmar/Thailand
- can stay in the period of intervention
Exclusion Criteria:
- Not HIV
- Living outside of Myanmar/Thailand
- Not care by MPG/CMRU
- Cannot stay for the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Protocol group
The intervention is modularized to eight weekly sessions of 2-hour group discussions.
The facilitator applies the principle of Cognitive Behavior Therapy and provides psychoeducation to promote the awareness and understanding of HIV stigma as well as training to help participants acquire alternative coping skills, such as relaxation techniques.
In five sessions, participants are introduced to the general cognitive-behavioral model of HIV stigma and are encouraged to track their thoughts, feelings, and behavioral responses when encountering external stigma or adverse events.
The participants further learn to differentiate helpful and non-helpful coping strategies and practice applying helpful coping skills to effectively reduce their HIV stigma.
In the other three sessions, participants further discuss more specific stigma that intersects with HIV stigma, including stigma in healthcare settings, access to social support, and available resources on the society levels.
|
The intervention is modularized to have eight weekly sessions of 2-hour group discussions, led by a trained facilitator.
The facilitator applies the principle of CBT and provides psychoeducation to promote the awareness and understanding of HIV stigma as well as training to help participants acquire alternative coping skills, such as relaxation techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Stigma Score From Baseline to End of Intervention in Protocol Group
Time Frame: Baseline and 8 weeks
|
Perceived Stigma Scale (PSS).
Each item is measured using a 4-point Likert scale and the scale contains four factors: personalized stigma (18 items, subscore total 18-72), disclosure concerns (12 items, subscore total 12-48), negative self-image (9 items, subscore total 9-36), and concern with public attitudes about people with HIV (12 items, subscore total 12-48).
Each factor is scored separately, with total score is computed by summing all 40 items, with a minimum total PSS score of 40 and a maximum possible score of 160.
Raw PSS scores were transformed into Stigma scores 1-4.
Higher scores reflect higher levels of perceived stigma.
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in QOL Score From Baseline to End of Intervention in the Protocol Group
Time Frame: Baseline and 8 weeks
|
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is a 12-item questionnaire that was used as a proxy measure of QOL in the study.
Total maximum score of CAMS-R is 48 and minimum score is 12. Raw CAMS-R scores were transformed into QOL scores 0-3.
Higher scores reflect better QOL.
|
Baseline and 8 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Chen WT, Huang F, Shiu CS, Lin SH, Tun MS, Nwe TW, Oo YTN, Oo HN. Can social support mediate stigma and perceived stress in people live with human immunodeficiency virus? AIDS Care. 2024 Feb;36(2):255-262. doi: 10.1080/09540121.2023.2254545. Epub 2023 Sep 6.
- Huang F, Chen WT, Shiu CS, Lin SH, Tun MS, New TW, Thet Nu Y, Oo HN. Psychometric Evaluation of a Myanmar Version of the Perceived Stress Scale for People Living with HIV/AIDS. J Nurs Meas. 2022 Dec 1;30(4):603-626. doi: 10.1891/JNM-D-21-00013.
- Huang F, Chen WT, Shiu CS, Lin SH, Tun MS, Nwe TW, Nu Oo YT, Oo HN. Adaptation and Validation of the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) in People Living with HIV in Myanmar. Mindfulness (N Y). 2022;13(1):188-197. doi: 10.1007/s12671-021-01784-5. Epub 2021 Nov 9.
- Huang F, Chen WT, Shiu CS, Lin SH, Tun MS, Nwe TW, Oo YTN, Oo HN. The Mediating Effects of Mindfulness on Perceived Stress From HIV Stigma in People Living With HIV in Myanmar: A Cross-sectional Study. J Assoc Nurses AIDS Care. 2022 Sep-Oct 01;33(5):559-566. doi: 10.1097/JNC.0000000000000352. Epub 2022 Jul 21.
- Aung MN, Stein C, Chen WT, Garg V, Saraswati Sitepu M, Thu NTD, Gundran CPD, Hassan MR, Suthutvoravut U, Soe AN, Nour M, Gyi KK, Brandl R, Yuasa M. Community responses to COVID-19 pandemic first wave containment measures: a multinational study. J Infect Dev Ctries. 2021 Aug 31;15(8):1107-1116. doi: 10.3855/jidc.15254.
- Huang F, Chen WT, Shiu CS, Lin SH, Tun MS, Nwe TW, Oo YTN, Oo HN. Adaptation and validation of a culturally adapted HIV stigma scale in Myanmar. BMC Public Health. 2021 Sep 13;21(1):1663. doi: 10.1186/s12889-021-11685-w.
- Huang F, Chen WT, Lin SH, Tun MS, Nwe TW, Oo YTN, Oo HN. Translation, Adaption, and Psychometric Testing of the Myanmar Version of the Medical Outcomes Study Social Support Survey for People Living With HIV/AIDS. Front Psychol. 2021 Sep 7;12:707142. doi: 10.3389/fpsyg.2021.707142. eCollection 2021.
- Chen WT, Shiu C, Lee FR, Moolphate S, Aung MN. Infrastructure collapsed, health care access disrupted, Myanmar people with chronic diseases are in danger. J Glob Health. 2023 Jan 11;13:03002. doi: 10.7189/jogh.13.03002. No abstract available.
- Chen WT, Sun W, Huang F, Shiu CS, Kim B, Candelario J, Toma L, Wu G, Ah-Yune J. Lost in Translation: Impact of Language Barriers and Facilitators on the Health Care of Asian Americans Living with HIV. J Racial Ethn Health Disparities. 2024 Aug;11(4):2064-2072. doi: 10.1007/s40615-023-01674-7. Epub 2023 Jun 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Behavior
- Social Behavior
- Acquired Immunodeficiency Syndrome
- Social Stigma
Other Study ID Numbers
- IRB# 18-001769
- R21TW011277 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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