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临床试验/NCT05357118
NCT05357118已完成不适用

Battling Stigma for Service Engagement Among Women With HIV in Vietnam

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2023年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Change in stigma

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

One arm

Experimental

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

干预措施: Suppress Stigma, Support Services (Behavioral)

结局指标

主要结局

Change in stigma

时间窗: 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)

次要结局

  • Change in social support(Baseline to 6-month)
  • Change in self-efficacy to tackle stigma and seek healthcare/social services(Baseline to 6-month)
  • Change in access to care(Baseline to 6-month)
  • Change in health status(Baseline to 6-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunqing Lin, PhD

Assistant Professor-in-Residence

University of California, Los Angeles

研究点 (1)

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