Stigma, SocialNCT05357118
Stigma Among Women With HIV in Vietnam
A study testing Suppress Stigma, Support Services in people with Stigma, Social and HIV Infections, run by University of California, Los Angeles at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stigma, Social, HIV Infections, Discrimination, Sex
- What is being tested?
- Suppress Stigma, Support Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteVietnam
- Study dates
- 30 Sep 2023to 18 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- have been involved in intervention development activities
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Battling Stigma for Service Engagement Among Women With HIV in Vietnam
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.
Read the 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.
- Conditions
- Stigma, Social, HIV Infections, Discrimination, Sex
- Being tested
- Suppress Stigma, Support Services
- Keywords
- Vietnam, Stigma, HIV, Women
- Medical subject headings
- Social Stigma, HIV Infections, Sexism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suppress Stigma, Support ServicesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| One arm | Experimental | The study is an one-arm pre- and post-design. Receives: Behavioral: Suppress Stigma, Support Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 6-month
Secondary outcomes (4)
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.
Measured: Baseline to 6-month
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).
Measured: Baseline to 6-month
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.
Measured: Baseline to 6-month
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.
Measured: Baseline to 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start30 Sep 2023
- Primary completion30 Sep 2023
- Study completion18 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stigma, SocialStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University, Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Chunqing Lin, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357118
- Sponsor's protocol ID
- 22-1191
- Other IDs
- R21TW012018
- Status last verified
- Mar 2025
- First submitted
- 6 Apr 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Battling Stigma for Service Engagement Among Women With HIV in Vietnam
- ClinicalTrials.gov ID
- NCT05357118
- Acronym / sponsor ID
- 22-1191
- Conditions
- Stigma, Social, HIV Infections, Discrimination, Sex
- Keywords
- Vietnam, Stigma, HIV, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Hanoi Medical University, Fogarty International Center of the National Institute of Health
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| One arm | Experimental | Behavioral: Suppress Stigma, Support ServicesThe study is an one-arm pre- and post-design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- have been involved in intervention development activities
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suppress Stigma, Support ServicesWomen 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 | Behavioural | One arm |
Primary outcome
Change in stigma
Time frame: Baseline to 6-month
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)
4 secondary outcomes
Change in social support
Time frame: Baseline to 6-month
Change in self-efficacy to tackle stigma and seek healthcare/social services
Time frame: Baseline to 6-month
Change in access to care
Time frame: Baseline to 6-month
Change in health status
Time frame: Baseline to 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suppress Stigma, Support Services in people with Stigma, Social and HIV Infections, run by University of California, Los Angeles at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stigma (time frame: Baseline to 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.