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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05126225
Other study ID # IRB# 18-001769
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date May 30, 2024

Study information

Verified date May 2023
Source University of California, Los Angeles
Contact Wei-ti Chen
Phone 310-206-8539
Email wchen@sonnet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date May 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. HIV-Positive 2. Care by Myanmar Positive Group/CMRU 3. Living in Myanmar/Thailand 4. can stay in the period of intervention Exclusion Criteria: 1. Not HIV 2. Living outside of Myanmar/Thailand 3. Not care by MPG/CMRU 4. Cannot stay for the study period

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Myanmar Myanmar Positive Group Yangon
Thailand Chiangmai Rajabhat University Chiang Mai

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles Chiangmai Rajabhat University

Countries where clinical trial is conducted

Myanmar,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stigma 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
Secondary QOL 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. 8 weeks
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