Resilience-Based Intervention for HIV/AIDS Stigma

Overseen By Xiaoming Li, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Incarceration, Institutionalization, Relocation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

1928 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of this treatment for reducing HIV/AIDS stigma?

Research shows that interventions like psycho-educational programs and workshops for healthcare providers can effectively reduce stigma for people living with HIV/AIDS and their families. These approaches have been found to improve knowledge and attitudes, which can help decrease stigma and improve mental health. ^{1 2 3 4 5}

Is the Resilience-Based Intervention for HIV/AIDS Stigma safe for humans?

The research articles reviewed do not provide specific safety data for the Resilience-Based Intervention for HIV/AIDS Stigma or related interventions like Family member intervention, Healthcare provider intervention, or PLWH intervention. They focus on the effectiveness of stigma reduction and behavioral interventions without mentioning safety concerns. ^{1 5 6 7 8}

How is the Resilience-Based Intervention for HIV/AIDS Stigma treatment different from other treatments for HIV/AIDS stigma?

This treatment is unique because it focuses on building resilience (the ability to recover from difficulties) among people living with HIV, their families, and healthcare providers to reduce stigma. Unlike other approaches, it emphasizes developing strengths and resources to cope with stigma, rather than just addressing stigma directly. ^{1 5 9 10 11}

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of a multilevel resilience-based intervention engaging PLWH, their family members, and healthcare providers

Not specified

Intervention Implementation

Implementation of the resilience-based intervention via a stepped wedge cluster randomized trial

36 months

7 waves of follow-up

Follow-up

Participants are monitored for changes in viral load, CD4 counts, and other clinical outcomes

36 months

7 waves of follow-up

Treatment Details

Interventions

• Family member intervention
• Healthcare provider intervention
• PLWH intervention

Trial Overview This 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

Group I: PLWH intervention sessions Experimental Treatment 1 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 intervention Experimental Treatment 1 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 intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Collaborator

Trials

7

Recruited

11,900+

Findings from Research

The community intervention in South Africa effectively reduced HIV stigma among people living with HIV (PLWH) and those close to them, enhancing relationships and increasing willingness to disclose HIV status.

Participants reported improved knowledge about stigma and coping strategies, empowering them to lead stigma reduction efforts in their communities, indicating a positive impact on community awareness and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive HIV stigma-reduction and wellness-enhancement community intervention: a case study. French, H., Greeff, M., Watson, MJ., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Self-Stigma Reduction Interventions for People Living with HIV/AIDS and Their Families: A Systematic Review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Impact of 'HIV-related stigma-reduction workshops' on knowledge and attitude of healthcare providers and students in Central India: a pre-test and post-test intervention study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Reducing HIV-related stigma in health care settings: a randomized controlled trial in China. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a multilevel intervention on the mental health of people living with HIV and their family members in rural China. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Associations Between Experienced HIV Stigma, Resulting Consequences, and the HIV Care Continuum: Moderating Effects of Two Resilience Characteristics Among Persons Living with HIV (PLWH) in Louisiana. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Knowledge of HIV status, sexual risk behaviors and contraceptive need among people living with HIV in Kenya and Malawi. [2018]

7. England pubmed.ncbi.nlm.nih.gov

HIV-related stigma and discrimination by healthcare workers in Egypt. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Behavioral Interventions to Reduce Sexual Risk Behavior in Adults with HIV/AIDS Receiving HIV Care: A Systematic Review. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Resilience-Based Intervention to Mitigate the Effect of HIV-Related Stigma: Protocol for a Stepped Wedge Cluster Randomized Trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A comprehensive HIV stigma-reduction and wellness-enhancement community intervention: a case study. [2015]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Factors Associated With HIV Disclosure and HIV-Related Stigma Among Adolescents Living With HIV in Southwestern Uganda. [2022]