NCT05174936Active, not recruiting
ResIlience-based Stigma REdUction Program ("Rise-up")
Mitigate the Effect of HIV-related Stigma Through a Resilience Approach
Source: ClinicalTrials.gov · Last updated 24 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1928 (actual)
- First submitted
- 29 Nov 2021
- Start date
- 1 Nov 2023
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- University of South Carolina
- Diseases
- HIV
- NCT number
- NCT05174936
What you commit to
- Study type: Interventional
- Participants enrolled: 1928
- From 1 Nov 2023 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- PLWH.
- The eligibility criteria for PLWH include:
- 1\) at least 18 years of age; 2) a confirmed diagnosis of HIV or AIDS; 3) with a detectable viral load (i.e., viral load≥50 copies/mL) or a viral round during the past year (a confirmed detectable viral load following a suppression); 4) willing to refer or give permission for us to contact one of their adult family member (either of origin or of choice) to participate (but the decision to participate will solely reside in the family member); 5) willing to provide a hair sample for test of hair cortisol and ARV hair concentration; 6) willing to consent the retrieval of their past and recent CD4 count and viral load from their medical charts; and 7) willing to be randomized to intervention condition at different time point in the stepped wedge trial.
- The exclusion criteria for PLWH include
- 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.
- The exclusion criteria for family members will be the same as PLWH.
- 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
- has regular contact with HIV-infected patients. The exclusion criteria for health care providers include
- 1\) a plan to permanently relocate outside of the province within a year.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of South Carolina Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.