- 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 (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wei-ti Chen
- Phone Number: 310-206-8539
- Email: wchen@sonnet.ucla.edu
Study Locations
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Yangon, Myanmar, 99999
- Recruiting
- Myanmar Positive Group
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Contact:
- Min San Tun, MS
- Phone Number: 9509421059688
- Email: minsantun@gmail.com
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Chiang Mai, Thailand, 50120
- Recruiting
- Chiangmai Rajabhat University
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Contact:
- Saiyud Moolphate, PhD
- Phone Number: 66-0-53-311-711
- Email: saiyudmoolphate@gmail.com
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stigma
Time Frame: 8 weeks
|
HIV stigma was assessed using the Perceived Stigma Scale (PSS), a 40-item scale.
Each item is measured using a 4-point Likert type and it contains four factors: personalized stigma (18 items), disclosure concerns (12 items), negative self-image (9 items), and concern with public attitudes about people with HIV (12 items).
Each factor (or subscale) is scored separately and the total score is computed by summing the 40 items.
Reliability coefficient alphas ranged from 0.90-.93 for the factors and 0.96 for the total scale and 2-3 week test/retest correlations ranged from 0.89-.92
(Berger, Ferrans, & Lashley, 2001).
|
8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QOL
Time Frame: 8 weeks
|
QOL was measured with Veterans SF (VSF)-12 Quality of Life.
VSF-12 is a 12-item health questionnaire developed from the U.S.
Each indicator variable is weighted for each of the response choices minus one.
The VSF-12 questionnaires have been administered nationally by the Veterans Administration (VA) where there have been more than 2.5 million administrations since 1996.
The eight domains are scored from 0 (worst) to 100 (best).
The scores are linear transformed t-tests, with 50 as the mean and 10 as the standard deviation (SD) based on a normally distributed population.
The VSF-12 was modified from the Medical Outcomes Study 36-item short-form (MOS SF-36) in domains that cover "role limitations due to physical and emotional problems" by replacement of dichotomized yes/no choices with a 5-point ordinal scale that ranges from "no, none of the time" to "yes, all of the time."
These changes increase the precision and discriminatory validity of the role scales, PCS, and MCS.
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8 weeks
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB# 18-001769
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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