Clinical trial NCT05357118: Stigma Among Women With HIV in Vietnam
Official title: Battling Stigma for Service Engagement Among Women With HIV in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigma, Social
HIV Infections
Discrimination, Sex
Keywords: Vietnam
Stigma
HIV
Women
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Hanoi Medical University
name: Fogarty International Center of the National Institute of Health
First posted: 2022-05-02
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in stigma
timeFrame: Baseline to 6-month
Secondary outcomes:
measure: Change in social support
timeFrame: Baseline to 6-month
measure: Change in self-efficacy to tackle stigma and seek healthcare/social services
timeFrame: Baseline to 6-month
measure: Change in access to care
timeFrame: Baseline to 6-month
measure: Change in health status
timeFrame: Baseline to 6-month
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
Study officials:
References: