Trial Outcomes & Findings for Buddhist Understanding and Reduction of Myanmar Experiences of HIV Stigma and Exclusion (NCT NCT05126225)
NCT ID: NCT05126225
Last Updated: 2025-12-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2025-12-29
Participant Flow
The mixed methods study included interviews (n=32), focus groups (n=60) and a single arm interventional trial (n=19). The first part of the study consisted of interviews and focus groups from different stakeholders (PLWH, healthcare providers, family members, friends, etc.) which gathered data that was used to inform the intervention; outcomes were not collected from these participants. The second part of the study implemented the intervention in a single-arm pilot study with PLWH participants.
Participant milestones
| Measure |
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.
Stigma reduction: 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.
|
Interview Group
To explore how PLWH experience and interpret HIV stigma in Myanmar and then identify key sociocultural factors, and, in particular, key components of Buddhism, which may shape PLWH's experiences of stigma, we conducted in-depth interviews during Phase 1 of the study. The participants making up the interview group were used to inform the adaptation of an existing intervention for use in people living with HIV from Myanmar. Outcomes were not collected from participants who participated in the interviews since they did not receive the study intervention.
|
Focus Group
After the initial adaption based on interviews, the first draft of the adapted intervention was presented to focus groups of Myanmar people living with HIV. A trained facilitator that matched the focus group members demographically led the discussions after the presentation of each module. All the discussion sessions were audiotaped. The focus group members completed a brief survey containing closed- and open-ended questions regarding the cultural appropriateness of various intervention components, including materials, metaphors, didactic methods, homework, and other content. Since the purpose of the feedback collected from focus groups was to judge the appropriateness, acceptability and feasibility of the adapted study intervention for use in the target population, outcomes were not collected from the focus group participants.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
32
|
60
|
|
Overall Study
COMPLETED
|
19
|
32
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The baseline stigma score was not collected from the interview and focus group participants.
Baseline characteristics by cohort
| Measure |
Protocol Group
n=19 Participants
The protocol group was comprised of the participants who received the final, adapted study intervention over the course of 8 weeks.
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.
Stigma reduction: 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.
|
Interview Group
n=32 Participants
Interviews were conducted during the first phase of the study. With the goal of culturally adapting an existing intervention for use among people living with HIV from Myanmar, in-depth interviews were conducted with people living with HIV from Myanmar to explore and identify Buddhist conceptualizations of HIV stigma. Participants in the interview group were not followed for outcomes or AEs.
|
Focus Group
n=60 Participants
During the second step of the study, focus groups made up of Myanmar people living with HIV were presented the adapted intervention. Feasibility, acceptability, and appropriateness was assessed that informed the final version of the adapted study intervention for use in the target population. Participants in the focus group were not followed for outcomes or AEs.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.4 years
n=19 Participants
|
39 years
n=32 Participants
|
39 years
n=60 Participants
|
37.8 years
n=111 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=19 Participants
|
20 Participants
n=32 Participants
|
20 Participants
n=60 Participants
|
49 Participants
n=111 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=19 Participants
|
12 Participants
n=32 Participants
|
40 Participants
n=60 Participants
|
62 Participants
n=111 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=19 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=111 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=19 Participants
|
32 Participants
n=32 Participants
|
60 Participants
n=60 Participants
|
111 Participants
n=111 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=19 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=19 Participants
|
32 Participants
n=32 Participants
|
60 Participants
n=60 Participants
|
111 Participants
n=111 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=19 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=19 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=19 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=19 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=111 Participants
|
|
Stigma score
|
2.2358 score
STANDARD_DEVIATION .56062 • n=19 Participants • The baseline stigma score was not collected from the interview and focus group participants.
|
—
|
—
|
2.2358 score
STANDARD_DEVIATION .56062 • n=19 Participants • The baseline stigma score was not collected from the interview and focus group participants.
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Single-arm analysis was conducted in the protocol group.
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.
Outcome measures
| Measure |
Protocol group
n=19 Participants
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.
Stigma reduction: 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.
|
|---|---|
|
Change in Stigma Score From Baseline to End of Intervention in Protocol Group
Pre-test stigma score
|
2.2358 score
Standard Deviation .56062
|
|
Change in Stigma Score From Baseline to End of Intervention in Protocol Group
Post-test stigma score
|
2.1760 score
Standard Deviation .69976
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Single-arm analysis was conducted in the protocol group.
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.
Outcome measures
| Measure |
Protocol group
n=19 Participants
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.
Stigma reduction: 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.
|
|---|---|
|
Change in QOL Score From Baseline to End of Intervention in the Protocol Group
Pre-test QOL score
|
2.73 score
Standard Deviation 0.82
|
|
Change in QOL Score From Baseline to End of Intervention in the Protocol Group
Post-test QOL score
|
2.68 score
Standard Deviation 0.90
|
Adverse Events
Protocol Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Wei-Ti Chen
University of California Los Angeles, Joe. C Wen School of Nursing
Phone: 310-206-8539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place