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Behavioural Intervention
Resilience-Based Intervention for HIV/AIDS Stigma
N/A
Waitlist Available
Led By Xiaoming Li, PhD
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 waves over 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a resilience-based intervention to reduce HIV-related stigma in Guangxi, China. The primary outcome is viral suppression among people living with HIV (PLWH), and the intermediate outcomes include resilience resources at the levels of individuals, the PLWH's real or surrogate family members, and healthcare facilities, as well as chronic stress response and adherence to treatment and care.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on psychosocial interventions rather than medications, traditional side effects are not applicable. However, participants may experience emotional discomfort when discussing sensitive topics related to HIV/AIDS stigma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 waves over 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 waves over 36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PLWH: change of CD4 counts at 36 months follow up
PLWH: change of viral load at 36 months follow up
Secondary study objectives
Family: change of intersecting stigma measures at 36 months follow up
Family: change of mental health measures at 36 months follow up
Family: change of quality of life measures at 36 months follow up
+19 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
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Who is running the clinical trial?
University of South CarolinaLead Sponsor
223 Previous Clinical Trials
117,282 Total Patients Enrolled
Guangxi Zhuang Autonomous Region Center for Disease Prevention and ControlOTHER_GOV
4 Previous Clinical Trials
5,421 Total Patients Enrolled
Xiaoming Li, PhDPrincipal InvestigatorUniversity of South Carolina
1 Previous Clinical Trials
790 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not in jail, planning to move, or in another study, and can participate fully.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.
Research Study Groups:
This trial has the following groups:- Group 1: Family member intervention
- Group 2: Health care provider intervention
- Group 3: PLWH intervention sessions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.