Resilience-Based Intervention for HIV/AIDS Stigma

Recruiting in Palo Alto (17 mi)

Overseen byXiaoming Li, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of South Carolina

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Xiaoming Li, PhD

Principal Investigator

University of South Carolina

Eligibility Criteria

The 'Rise-up' trial is for adults over 18 with HIV or AIDS, a detectable viral load, and willing to involve a family member. They must be able to provide hair samples, allow medical chart access, and not plan on relocating soon. Those mentally or physically unable to participate or involved in other studies are excluded.

Inclusion Criteria

I am over 18, support someone with HIV, referred by them, and open to study participation.

PLWH: 1) at least 18 years of age; 2) a confirmed diagnosis of HIV or AIDS; 3) with a detectable viral load (viral load≥50 copies/mL) or a viral rebound during the past year; 4) willing to refer or give permission for us to contact one of their adult family members to participate; 5) willing to provide a hair sample for test of hair cortisol and ARV hair concentration; 6) willing to consent to the retrieval of their past and recent CD4 count and viral load from their medical charts; 7) willing to be randomized to intervention condition at different time points in the stepped wedge trial

I am over 18, work at a participating HIV clinic, and regularly see HIV patients.

Exclusion Criteria

I am not in jail, planning to move, or in another study, and can participate fully.

Family members: Same as PLWH criteria

Health care providers: Plan to permanently relocate outside of the province within a year

Treatment Details

Interventions

Family member intervention (Behavioural Intervention)
Healthcare provider intervention (Behavioural Intervention)
PLWH intervention (Behavioural Intervention)

Trial OverviewThis study tests a resilience-based intervention aimed at reducing HIV-related stigma among patients, their families, and healthcare providers in China. It uses a stepped-wedge design to measure outcomes like viral suppression and treatment adherence.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: PLWH intervention sessionsExperimental Treatment1 Intervention

The PLWH in this arm will receive five 2-hour intervention sessions delivered over five weeks (one session per week) in the clinics. Two trained facilitators will deliver the materials through interactive trainings that include multimedia presentations, group discussions, role-play, personal testimonies, and/or games. The same two facilitators will deliver all five sessions within a clinic to increase group cohesion and rapport with PLWH. The goal of this intervention is to assist PLWH in identifying and developing internal and external resilience resources to aid in coping HIV stigma.

Group II: Health care provider interventionExperimental Treatment1 Intervention

The HCP intervention curriculum consists of four 1.5-hour sessions (e.g., one per week) that will be delivered in small groups in the clinic setting by trained facilitators (e.g., health educators from Guangxi CDC). The delivery schedule and format will be flexible and individually tailored (e.g., four sessions can be given one per week or consolidated into two longer sessions). The goal of this intervention is to reduce the institutional stigmatizing attitudes and practices toward PLWH and other social identities, such as MSM, sex workers, and drug users, and improving the provider-patient relationships.

Group III: Family member interventionExperimental Treatment1 Intervention

The intervention sessions for family members will be similar to PLWH sessions in terms of format and content and will be led by trained facilitators. Family member intervention sessions will emphasize supporting PLWH to cope with HIV-related stigma and to improve their clinical outcomes. The goal of this intervention is to provide social support for PLWH's resilience building as well as foster resilience at the family level.