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| ID | Type | Description | Link |
|---|---|---|---|
| R21TW011277 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Chiangmai Rajabhat University | UNKNOWN |
| Fogarty International Center of the National Institute of Health | NIH |
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This project aims to explore a multi-leveled conceptualization of the effects of HIV stigma on HIV care engagement in Myanmar by conducting a mixed-method study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protocol group | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stigma reduction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stigma Score From Baseline to End of Intervention in 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. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QOL Score From Baseline to End of Intervention 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. | Baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myanmar Positive Group | Yangon | Myanmar | 99999 | Burma | ||
| Chiangmai Rajabhat University |
Data upon request.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Protocol Group | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Stigma Score From Baseline to End of Intervention in 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. | Single-arm analysis was conducted in the protocol group. | Posted | Mean | Standard Deviation | score | Baseline and 8 weeks |
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AEs were collected weekly over a period of 8 weeks in the protocol group.
Since the purpose of the first phase of the study was to adapt an existing intervention for use in the target population, adverse events were not collected from the participants in the interview and focus groups. Participants in the protocol group were assessed for adverse events over a span of 8 weeks while receiving the study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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A small sample size limits the statistical power of a study, making it difficult to detect meaningful differences or relationships even if they exist. This can result in non-significant findings and wide confidence intervals, reducing confidence in the estimated effect size. Consequently, the results may not accurately represent the population or reflect the true effectiveness of the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wei-Ti Chen | University of California Los Angeles, Joe. C Wen School of Nursing | 310-206-8539 | wchen@sonnet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2022 | Oct 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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The intervention is modularized to have eight weekly sessions of 2-hour group discussions, led by a trained facilitator.
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|
| Chiang Mai |
| Chiang Mai |
| 50120 |
| Thailand |
| BG001 | Interview Group | 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. |
| BG002 | Focus Group | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Stigma score | Perceived Stigma Scale (PSS). Each item 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 PLWH (12 items, subscore total 12-48). Each factor is scored separately. PSS score computed by summing 40 items, with a minimum total 40 and maximum score 160. Raw PSS scores were transformed into Stigma scores 1-4. Higher scores reflect higher levels of perceived stigma. | The baseline stigma score was not collected from the interview and focus group participants. | Mean | Standard Deviation | score |
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| Secondary | Change in QOL Score From Baseline to End of Intervention 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. | Single-arm analysis was conducted in the protocol group. | Posted | Mean | Standard Deviation | score | Baseline and 8 weeks |
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|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|