Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05357118
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2022-04-06
Brief Title:
Stigma Among Women With HIV in Vietnam
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Battling Stigma for Service Engagement Among Women With HIV in Vietnam
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Women living with HIVAIDS 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 WLHAs 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 onlineoffline 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 WLHAs 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 HIVAIDS 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 WLHAs cognitive emotional and behavioral responses to stigma and test strategies to address the adverse impact of stigma on WLHAs 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 WLHAs 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 obstetricsmaternity clinics community-based organizations and womens 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 eg 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 physicalmental health In addition final focus groups will be organized with participating WLHA to collect feasibilityacceptability evaluations and feedback for intervention components The information will be used to refine the intervention and its implementation plan
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 WLHAs 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 obstetricsmaternity clinics community-based organizations and womens 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 eg 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 physicalmental health In addition final focus groups will be organized with participating WLHA to collect feasibilityacceptability evaluations and feedback for intervention components The information will be used to refine the intervention and its implementation plan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None