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ACTIVE NOT RECRUITING
NCT05174936
NA

ResIlience-based Stigma REdUction Program ("Rise-up")

Sponsor: University of South Carolina

View on ClinicalTrials.gov

Summary

Stigma and discrimination related to HIV and AIDS ("HIV-related stigma") have been identified worldwide as major barriers to HIV treatment and care, posing challenges to HIV prevention efforts and provision of adequate care, support, and treatment. Despite decades of global efforts to tackle HIV-related stigma, previous interventions designed to reduce stigma have been largely ineffective. The knowledge gaps and challenges for combating HIV-related stigma are partly rooted in the complexity and diversity of the stigma and partly in the limitations in current conceptualization of stigma reduction efforts. Recent research, including our own preliminary data, has shown the promise of resilience approaches that focus on the development of strengths, competencies, resources, and capacities of people living with HIV (PLWH) and those of their real or surrogate family members and healthcare facilities to prevent, reduce, and mitigate the negative effects of stigma. However, the resilience approach, while hypothesized, has not been widely tested in intervention trials. In the current application, we propose to develop, implement, and evaluate a theory-guided, multilevel multimode resilience-based intervention via a stepped-wedge randomized trial among 800 PLWH and their real or surrogate family members as well as 320 healthcare providers in Guangxi, China where we have built a strong research infrastructure and community collaboration through NIH-funded research since 2004. The primary outcome will be viral suppression among PLWH, and the intermediate outcomes will include resilience resources at the levels of individuals, the real or surrogate family members, and healthcare facilities as well as chronic stress response and adherence to treatment and care. The proposed study is innovative as it addresses a number of knowledge gaps in HIV-related stigma reduction intervention research based on both a conceptualization of stigma reduction and advancement in intervention research methodology (e.g., multilevel and multi-component intervention modality, a stepped wedge design, the addition of biomarkers to assess the effects of stigma, and targeting primary HIV clinical outcomes such as viral suppression). The proposed research is significant as it addresses a critical public health issue in the US and globally. The proposed intervention protocol, if proven efficacious, has the potential to be replicated in other low- and middle-income countries to mitigate the negative impact of stigma on the HIV treatment and care continuum.

Official title: Mitigate the Effect of HIV-related Stigma Through a Resilience Approach

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1928

Start Date

2023-11-01

Completion Date

2027-11-30

Last Updated

2024-09-24

Healthy Volunteers

No

Interventions

BEHAVIORAL

PLWH intervention

The intervention curriculum will consist of five interactive training sessions (2 hours each) with four specific areas of resilience-building: individual assets (self-esteem, emotion regulation, positive future orientation), coping with infection/illness (medical adherence, stress reduction, healthy lifestyle, self-care), relationship building (family relationship, provider-patient relationship), and social support (identifying and seeking social support at various socioecological levels).

BEHAVIORAL

Family member intervention

The intervention will consist of five sessions of group activities (2 hours each), with each session addressing one or more of the following areas: 1) HIV and ART knowledge; 2) support to strengthen the capacity of PLWH and their family members to adapt to living with HIV; 3) relationship building (family relationships, intimate relationships); 4) emotional and behavioral support for PLWH's adherence to care and treatment, including tailored coping or support strategies to address unique needs of some participants who may be more prone to HIV stigma (e.g., MSM and their family members); and 5) self-care.

BEHAVIORAL

Healthcare provider intervention

The HCP intervention will adapt Popular Opinion Leaders (POL) principles by teaching participants skills for initiating/disseminating stigma reduction messages/practices to colleagues in the workplace. The HCP intervention will consist of four 1.5-hour sessions addressing the following topics: 1) universal HIV precautions and occupational safety (e.g., correctly knowing and practicing universal precautions and decreasing fear of PLWH); 2) intersecting stigma against PLWH (e.g., manifestations of intersecting stigma in clinical settings); 3) provider-patient relationship (e.g., reducing stigmatizing attitudes and behaviors toward PLWH, respecting patients' rights for privacy related to care and disclosure); 4) improving quality of patient care (e.g., increasing skills and comfort in working with PLWH); 5) building a supportive medical environment for better care of PLWH; and 6) skills and confidence in delivering stigma reduction messages to coworkers.

Locations (1)

University of South Carolina

Columbia, South Carolina, United States