NCT05126225

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable hiv

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 29, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

3.4 years

First QC Date

October 26, 2021

Results QC Date

October 16, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

stigmaMindfulnessMyanmar

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in QOL Score From Baseline to End of Intervention in the Protocol Group

    Baseline and 8 weeks

Study Arms (1)

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.

Behavioral: Stigma reduction

Interventions

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.

Protocol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-Positive
  • Care by Myanmar Positive Group/CMRU
  • Living in Myanmar/Thailand
  • can stay in the period of intervention

You may not qualify if:

  • Not HIV
  • Living outside of Myanmar/Thailand
  • Not care by MPG/CMRU
  • Cannot stay for the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Myanmar Positive Group

Yangon, Myanmar, 99999, Burma

Location

Chiangmai Rajabhat University

Chiang Mai, Chiang Mai, 50120, Thailand

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSocial Stigma

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSocial BehaviorBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Wei-Ti Chen
Organization
University of California Los Angeles, Joe. C Wen School of Nursing

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The intervention is modularized to have eight weekly sessions of 2-hour group discussions, led by a trained facilitator.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 18, 2021

Study Start

July 1, 2020

Primary Completion

November 19, 2023

Study Completion

April 30, 2024

Last Updated

December 29, 2025

Results First Posted

December 29, 2025

Record last verified: 2025-12

Locations