HIV Infections Clinical Trial
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | May 2024 |
Est. primary completion date | September 19, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | Hanoi Medical University | Hanoi |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Hanoi Medical University |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Baseline to 6-month | |
Secondary | 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. | Baseline to 6-month | |
Secondary | 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). | Baseline to 6-month | |
Secondary | 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. | Baseline to 6-month | |
Secondary | 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. | Baseline to 6-month |
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