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Stigma Among Women With HIV in Vietnam

Primary Purpose

Stigma, Social, HIV Infections, Discrimination, Sex

Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Suppress Stigma, Support Services
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stigma, Social focused on measuring Vietnam, Stigma, HIV, Women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 18 or above
  • being female at birth and currently
  • being HIV-seropositive
  • currently living in Hanoi and having no plan to move out of the area in the next six months
  • have the cognitive capacity to participate in study activities as judged by the study recruiter

Exclusion Criteria:

  • have been involved in intervention development activities
  • inability to give informed consent

Sites / Locations

  • Hanoi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One arm

Arm Description

The study is an one-arm pre- and post-design.

Outcomes

Primary Outcome Measures

Change in stigma
The change in a scale to measure how WLHA's awareness of HIV stigma, agreement with stigma, coping with stigma. The items of the stigma measure are adopted based on Corrigan PW's Toolkit for Evaluating Programs Meant to Erase the Stigma of Mental Illness. (2008)

Secondary Outcome Measures

Change in social support
The change in social support measure appraisal support, informational support, emotional support, and spiritual support. The UCLA Social Support Inventory will be used (Schwarzer R, Dunkel-Schetter C, Kemeny M. The multidimensional nature of received social support in gay men at risk of HIV infection and AIDS. Am J Community Psychol. 1994 Jun;22(3):319-39. doi: 10.1007/BF02506869). Range 16-80, higher score indicates higher level of perceived social support.
Change in self-efficacy to tackle stigma and seek healthcare/social services
The change in self-efficacy measure evaluates WLHA's level of confidence to tackle stigma and seek healthcare/social services, measured using the HIV Self-Efficacy (HIV-SE) scale developed by Shively and colleagues (Shively M, Smith T, Bormann J, Gifford A. Evaluating self-efficacy for HIV disease management skills. AIDS Behav. 2002;6:371-379. doi: 10.1023/A:1021156914683). The scale contains six domains including managing mood, managing medications, managing symptoms, managing fatigue, communicating with the healthcare provider, and getting support (Range 18-180, a higher score indicates a higher level of self-efficacy to tackle stigma and seek care).
Change in access to care
The change in a measure evaluate WLHA's access to antiretroviral therapy and treatment for other comorbidities, adhering to medications, managing symptoms, and communicating with service providers, measured using the Barriers to Access to Care Evaluation scale (BACE; Clement, S., Brohan, E., Jeffery, D., Henderson, C., Hatch, S. L., & Thornicroft, G. (2012). Development and psychometric properties the Barriers to Access to Care Evaluation scale (BACE) related to people with mental ill health. BMC psychiatry, 12(1), 36). Range 12-48, higher score indicates higher barriers to access to treatment and care.
Change in health status
The change in to measure evaluates WLHA's multidimensional health status, including physical health, physical functioning, mental health, and social functioning, measured with the SF-12 Health Survey (79. Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. PMID: 8628042). Range 0-100; higher score indicates better physical and mental health.

Full Information

First Posted
April 6, 2022
Last Updated
May 30, 2023
Sponsor
University of California, Los Angeles
Collaborators
Hanoi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05357118
Brief Title
Stigma Among Women With HIV in Vietnam
Official Title
Battling Stigma for Service Engagement Among Women With HIV in Vietnam
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Hanoi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Women living with HIV/AIDS (WLHA) bear a higher level of stigma because of their socio-cultural vulnerabilities. Women are more likely to internalize social stigma and produce a sense of shame and loss of self-worth, which results in a delay in health service seeking and compromised health outcomes. In Vietnam, stigma towards WLHA is exacerbated by the deeply rooted female inferiority. However, research targeting WLHA is generally lacking. We propose this study to address stigma among WLHA and explore the use of virtual support system in WLHA's service engagement in Vietnam. The 2-year study will proceed in two phases in Hanoi, Vietnam. Phase 1 will be formative studies, including in-depth interviews with 30 WLHA and focus groups with 20 service providers and community stakeholders. This phase aims to investigate the cultural and contextual background of HIV and gender roles in Vietnam and to identify effective strategies to support and engage WLHA in healthcare. These formative findings will inform the development of an intervention to be pilot tested in the next phase. Phase 2 will be a 6-month intervention pilot with 90 WLHA using an online/offline hybrid approach. During Month 1 of the pilot, WLHA will participate in an in-person section to form mutual support groups and prepare for the following online components. During Month 2-4 of the pilot, study investigators will teach WLHA a series of empowerment strategies to cope with stigma and utilize social support to seek healthcare services. These skills will be taught via interactive online group activities. During Month 4-6, WLHA will self-administer the online groups without the intervention of study investigators. WLHA's multidimensional stigma measures, mental health burdens, and service use self-efficacy will be assessed at baseline, month 4, and month 6. Progress data of the intervention will be documented to inform the feasibility and sustainability of the online support approach. Acceptability data and feedback will be collected from the WLHA participants upon completion of the 6-month pilot period.
Detailed Description
Women living with HIV/AIDS (WLHA) bear HIV stigma layered with gender disparity. They continue to suffer from internalized shame, which compromises their mental health and discourages them from seeking healthcare. Stigma among WLHA has the most detrimental impact on WLHA in Asian Countries, such as Vietnam, due to the deeply rooted male supremacy in the culture. The objective of this study is to investigate Vietnamese WLHA's cognitive, emotional, and behavioral responses to stigma, and test strategies to address the adverse impact of stigma on WLHA's health and service seeking. This proposed 2-year study, which will be conducted in Hanoi, Vietnam, will proceed in two phases. In Phase 1, we will conduct formative studies, including in-depth interviews with 30 WLHA, one focus group with 10 healthcare providers, and one focus group with 10 community stakeholders. The aim of the formative study is to explore the cultural and contextual background of HIV stigma and gender disparity in Vietnam, investigate WLHA's barriers to access healthcare, identify locally available resources to combat stigma, and solicit feedback on some of the potential stigma-reduction intervention strategies. Phase 1 findings will inform the strategies to be pilot tested in Phase 2. In Phase 2, the intervention will be piloted among 90 WLHA. The WLHA participants will be recruited from HIV testing sites, HIV outpatient clinics, obstetrics/maternity clinics, community-based organizations, and women's associations in Hanoi. The pilot testing period will be approximately six months. During the first month (Month 1), the WLHA will attend a group session to build initial contact with each other and prepare for the following online activities. During the preparation session, online support groups will be established using popular local socializing applications (e.g., Facebook). There will be approximately 30 WLHA in each online group. During the following three months (Month 2-4), study investigators will deliver stigma reduction intervention in the online groups, with focuses to address cognitive process of societal stigma, adjust negative emotional responses to stigma, and promote positive coping and active services seeking. During the final two months (Month 5-6), WLHA will continue the discussion and mutual support activities in the online groups without the intervention of study investigators. The online discussions will serve as process data to inform the usability and sustainability of the intervention. WLHA participants will be surveyed at baseline, 4-, and 6-month to assess their cognitive, emotional, behavioral responses to stigma, perceived social support, service utilization, and physical/mental health. In addition, final focus groups will be organized with participating WLHA to collect feasibility/acceptability evaluations and feedback for intervention components. The information will be used to refine the intervention and its implementation plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stigma, Social, HIV Infections, Discrimination, Sex
Keywords
Vietnam, Stigma, HIV, Women

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Women living with HIV/AIDS (WLHA) will attend an initial group preparation session in Month 1 to form a network with peers and prepare for the following online support groups. During Month 2-4, study investigators will teach cognitive, emotional, and behavioral strategies to cope with stigma and utilize social support to seek healthcare services through online group activities. During Month 4-6, WLHA will self-administer the online support groups without the intervention of study investigators
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One arm
Arm Type
Experimental
Arm Description
The study is an one-arm pre- and post-design.
Intervention Type
Behavioral
Intervention Name(s)
Suppress Stigma, Support Services
Intervention Description
Women living with HIV/AIDS (WLHA) will attend an initial group preparation session in Month 1 to form a network with peers and prepare for the following online support groups. During Month 2-4, study investigators will teach cognitive, emotional, and behavioral strategies to cope with stigma and utilize social support to seek healthcare services through online group activities. During Month 4-6, WLHA will self-administer the online support groups without the intervention of study investigators
Primary Outcome Measure Information:
Title
Change in stigma
Description
The change in a scale to measure how WLHA's awareness of HIV stigma, agreement with stigma, coping with stigma. The items of the stigma measure are adopted based on Corrigan PW's Toolkit for Evaluating Programs Meant to Erase the Stigma of Mental Illness. (2008)
Time Frame
Baseline to 6-month
Secondary Outcome Measure Information:
Title
Change in social support
Description
The change in social support measure appraisal support, informational support, emotional support, and spiritual support. The UCLA Social Support Inventory will be used (Schwarzer R, Dunkel-Schetter C, Kemeny M. The multidimensional nature of received social support in gay men at risk of HIV infection and AIDS. Am J Community Psychol. 1994 Jun;22(3):319-39. doi: 10.1007/BF02506869). Range 16-80, higher score indicates higher level of perceived social support.
Time Frame
Baseline to 6-month
Title
Change in self-efficacy to tackle stigma and seek healthcare/social services
Description
The change in self-efficacy measure evaluates WLHA's level of confidence to tackle stigma and seek healthcare/social services, measured using the HIV Self-Efficacy (HIV-SE) scale developed by Shively and colleagues (Shively M, Smith T, Bormann J, Gifford A. Evaluating self-efficacy for HIV disease management skills. AIDS Behav. 2002;6:371-379. doi: 10.1023/A:1021156914683). The scale contains six domains including managing mood, managing medications, managing symptoms, managing fatigue, communicating with the healthcare provider, and getting support (Range 18-180, a higher score indicates a higher level of self-efficacy to tackle stigma and seek care).
Time Frame
Baseline to 6-month
Title
Change in access to care
Description
The change in a measure evaluate WLHA's access to antiretroviral therapy and treatment for other comorbidities, adhering to medications, managing symptoms, and communicating with service providers, measured using the Barriers to Access to Care Evaluation scale (BACE; Clement, S., Brohan, E., Jeffery, D., Henderson, C., Hatch, S. L., & Thornicroft, G. (2012). Development and psychometric properties the Barriers to Access to Care Evaluation scale (BACE) related to people with mental ill health. BMC psychiatry, 12(1), 36). Range 12-48, higher score indicates higher barriers to access to treatment and care.
Time Frame
Baseline to 6-month
Title
Change in health status
Description
The change in to measure evaluates WLHA's multidimensional health status, including physical health, physical functioning, mental health, and social functioning, measured with the SF-12 Health Survey (79. Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. PMID: 8628042). Range 0-100; higher score indicates better physical and mental health.
Time Frame
Baseline to 6-month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Born as a female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 18 or above being female at birth and currently being HIV-seropositive currently living in Hanoi and having no plan to move out of the area in the next six months have the cognitive capacity to participate in study activities as judged by the study recruiter Exclusion Criteria: have been involved in intervention development activities inability to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunqing Lin
Phone
3107940361
Email
lincq@ucla.edu
Facility Information:
Facility Name
Hanoi Medical University
City
Hanoi
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minh Giang Le, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared with other researchers

Learn more about this trial

Stigma Among Women With HIV in Vietnam

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