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

NCT05174936 | Active Not Recruiting DMC

• 1 other identifier: Pro00099388
• Study Type: interventional
• Target: 1,928
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS; Stigma, Social; Emotional Adjustment

Outcome Measures

Primary Outcomes (2)

• PLWH: change of viral load at 36 months follow up

  The most recent viral load

  7 waves during 36 months follow up

• PLWH: change of CD4 counts at 36 months follow up

  The most recent CD4 counts

  7 waves during 36 months follow up

Secondary Outcomes (22)

• PLWH: change of HIV-related stigma at 36 months follow up

  7 waves during 36 months follow up

• PLWH: Change of depression at 36 months follow up

  7 waves during 36 months follow up

• PLWH: Change of stress at 36 months follow up

  7 waves during 36 months follow up

• PLWH: change of adherence to clinical appointments and medication

  7 waves during 36 months follow up

• PLWH: change of substance use measures at 36 months follow up

  7 waves during 36 months follow up

Study Arms (3)

PLWH intervention sessions

EXPERIMENTAL

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.

Behavioral: PLWH intervention

Family member intervention

EXPERIMENTAL

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.

Behavioral: Family member intervention

Health care provider intervention

EXPERIMENTAL

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.

Behavioral: Healthcare provider intervention

Interventions

PLWH intervention BEHAVIORAL

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).

PLWH intervention sessions

Family member intervention BEHAVIORAL

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.

Family member intervention

Healthcare provider intervention BEHAVIORAL

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.

Health care provider intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• mental or physical inability to respond to assessment questions or to participate in intervention;
• currently incarcerated or institutionalized for drug use or commercial sex;
• participating in other intervention activities during the current study period; and
• plan to permanently relocate outside of the province within a year. Physical and developmental inability will be screened by the local research team in consultation with physicians at the participating clinics.
• Family members. The eligibility criteria for family members include
• at least 18 years of age;
• either family member of origin or family member of choice who provide emotional and other social support to study PLWH;
• have been referred by case PLWH to participate in the study; and
• willing to be randomized (along with study PLWH) to intervention condition.
• Note: An HIV-infected family member will be eligible to participate. The decision of the family member to or not to participate will not affect the eligibility of PLWH to participate. Based on our experience working with PLWH in Guangxi, we anticipate that at least 80% of the referred family members will participate. With appropriate consent, we will collect brief information (e.g., key demographic characteristics and treatment profiles) on those PLWH who either cannot identify a family member (of origin or of choice) or her/his family member refuses to participate for potential secondary analysis to inform the refinement and scale-up of the proposed intervention in the future.
• Health care providers. The eligibility criteria for health care providers include:
• at least 18 years of age;
• provides health care services at one of the participating HIV clinics; and
• \) a plan to permanently relocate outside of the province within a year.

Sponsors & Collaborators

• University of South Carolina: lead
• Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

• Li X, Qiao S, Yang X, Harrison SE, Tam CC, Shen Z, Zhou Y. A Resilience-Based Intervention to Mitigate the Effect of HIV-Related Stigma: Protocol for a Stepped Wedge Cluster Randomized Trial. Front Public Health. 2022 Mar 29;10:857635. doi: 10.3389/fpubh.2022.857635. eCollection 2022.

  PMID: 35425746 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Social Stigma

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior

Study Officials

• Xiaoming Li, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Endowed Chair

Model Details: The proposed multimodal intervention will include three sessions: the PLWH sessions (individual resilience-building), the Family member intervention (social support for PLWH\'s resilience building and fostering resilience at the family level), and HCP intervention (reducing the institutional stigmatizing attitudes and practices toward PLWH)

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 3, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)