Integrated Stigma Reduction Interventions for HIV/AIDS

Not currently recruiting at 1 trial location

Overseen By Fred M Ssewamala, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Antiretroviral therapy

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 24

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how well different strategies reduce HIV viral levels in adolescents living with HIV. It compares three approaches: standard care with enhancements (Bolstered Standard of Care, BSOC), family group sessions addressing stigma and enhancing family finances (Multiple Family Groups for HIV stigma reduction, MFG-HIVSR, plus FEE), and the family approach combined with sessions educating school staff about stigma (MFG-HIVSR plus FEE plus Group-based stigma reduction for educators, GED-HIVSR). Participants should be HIV-positive teenagers on antiretroviral therapy, attending a boarding school, and willing to have their caregivers and educators join the study. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative strategies that could improve the quality of life for adolescents living with HIV.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since participants must be on antiretroviral therapy, it seems likely that you will continue with your current HIV treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that programs designed to reduce HIV stigma are generally safe and well-tolerated. Studies have found that initiatives like Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) effectively lower stigma levels without major safety issues. These programs have been used worldwide and have successfully reduced both internalized stigma and its negative impact on health.

For the combined approach, which includes MFG-HIVSR, Family Economic Empowerment (FEE), and Group-based stigma reduction for educators (GED-HIVSR), previous studies also support its safety. This method has been used to overcome barriers to HIV treatment in schools and families, with no significant adverse events reported.

Since the current trial phase does not require safety data, it is reasonable to assume that major safety concerns would necessitate more thorough testing. This suggests confidence in the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they tackle HIV stigma on multiple fronts, which is different from traditional treatments that mainly focus on medical care. The Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) with Family Education and Empowerment (FEE) aims to reduce stigma by involving families and educating them, creating a supportive environment for individuals with HIV. Adding Group-based stigma reduction for educators (GED-HIVSR) further extends this support by educating teachers, who can influence broader community attitudes. These interventions not only aim to reduce stigma but also empower families and educators to foster acceptance and understanding, potentially transforming societal perceptions of HIV/AIDS.

What evidence suggests that this trial's treatments could be effective for HIV stigma reduction?

Research has shown that reducing HIV stigma can improve health outcomes for people living with HIV. In this trial, participants in Treatment Arm 1 will receive a combination of Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) and Family Economic Empowerment (FEE). This combination addresses stigma by promoting family support and financial stability, potentially improving adherence to HIV treatments. Participants in Treatment Arm 2 will receive this combination plus Group-based stigma reduction for educators (GED-HIVSR), which educates teachers and enhances school environments for adolescents with HIV. This approach aims to create supportive communities at home and school, helping young people manage their health better. Early results suggest these interventions could help maintain low virus levels in the body. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adolescents living with HIV who are on antiretroviral therapy and enrolled in boarding schools. Their caregivers, as well as school staff like teachers and nurses willing to participate, can join. It's not for those with cognitive impairments that affect understanding of the study or who can't commit to finishing it.

Inclusion Criteria

I am on antiretroviral therapy.

HIV-positive adolescents confirmed by medical report

Enrolled in primary and secondary schools in a boarding section

Exclusion Criteria

I understand the study and am willing to complete it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a multi-level intervention aimed at reducing HIV stigma and improving treatment adherence, including group-based stigma reduction for educators and family economic empowerment.

20 months

Assessments at baseline, 12, 24, and 36 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments focusing on viral suppression, adherence, and stigma reduction.

36 months

Follow-up assessments at 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Bolstered Standard of Care (BSOC)
• Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE
• Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR).

Trial Overview The M-Suubi study compares three approaches: Bolstered Standard of Care (BSOC), Multiple Family Groups plus economic empowerment (MFG-HIVSR plus FEE), and these two combined with a stigma reduction program for educators (GED-HIVSR). Schools will be randomly assigned one of these methods.

How Is the Trial Designed?

Group I: Treatment Arm 2 Experimental Treatment 3 Interventions

Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR)

Group II: Treatment Arm 1 Experimental Treatment 2 Interventions

Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE

Group III: Control Arm Experimental Treatment 1 Intervention

Bolstered Standard of Care (BSOC)

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Reducing stigma and discrimination related to HIV and AIDS is essential for achieving an AIDS-free generation, as highlighted by recent political initiatives from UNAIDS, UN, and PEPFAR.

To effectively incorporate stigma reduction into national AIDS plans, the research community must standardize intervention assessments, clearly connect activities to specific stigma domains, and link these reductions to improved HIV prevention and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Global action to reduce HIV stigma and discrimination. Grossman, CI., Stangl, AL.[2022]

The HIV Stigma Scale was revised and shortened from 40 to 32 items based on a study of 157 individuals living with HIV/AIDS, maintaining four key factors that measure different aspects of stigma.

The revised scale demonstrated high internal consistency (Cronbach's alphas between .90 and .97), confirming its reliability and validity for assessing stigma perceptions among people living with HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of stigma in people with HIV: a reexamination of the HIV Stigma Scale. Bunn, JY., Solomon, SE., Miller, C., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36197706/

A Multilevel Integrated Intervention to Reduce the Impact of ... The results will expand our understanding of effective intervention strategies for reducing stigma among HIV-infected and noninfected ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9582915/

A Multilevel Integrated Intervention to Reduce the Impact of ... ... MFG-HIVSR: multiple family groups HIV stigma reduction for educators. ... H2c: MFG-HIVSR plus FEE plus GED-HIVSR will have lower mean HIV stigma than MFG-HIVSR ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05307250?cond=HIV%2FAIDS&amp;page=3&amp;rank=30

M-Suubi: A Multi-Level Integrated Intervention to Reduce ... Building on our research and current evidence on HIV stigma reduction, the investigators propose a multi-level three-arm cluster randomized study (M-Suubi) with ...

4. clinicaltrial.be clinicaltrial.be/en/details/30455?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

M-Suubi: A Multi-Level Integrated Intervention to Reduce... Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR). Behavioral. In ...

5. withpower.com withpower.com/trial/phase-acquired-immunodeficiency-syndrome-3-2022-cefcd

Integrated Stigma Reduction Interventions for HIV/AIDS Research shows that interventions aimed at reducing HIV stigma can be effective, at least in the short term, and participation in mental health services ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11290898/

An Analysis of Approaches to Reduction of HIV Stigma across ... The present research investigated 31 interventional studies carried out from 2008 to 2020 on the reduction of stigma across the world.

7. reporter.nih.gov reporter.nih.gov/project-details/11094932

Testing a multicomponent intervention to improve HIV ... Previous iterations have shown effectiveness in reducing internalized stigma. We propose to adapt the engagement intervention model with Caribbean-born people ...

8. researchgate.net researchgate.net/publication/395924425_An_Analysis_of_Approaches_to_Reduction_of_HIV_Stigma_across_the_World_through_educational_interventions_A_Scoping_Review_An_Analysis_of_Approaches_to_Reduction_of_HIV_Stigma_across_the_World_through_e

An Analysis of Approaches to Reduction of HIV Stigma ... Widespread implementation of UTT shows promise for reducing multiple dimensions of stigma, which is critical for improving health outcomes among ...

9. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2018.00165/full

HIV Stigma Reduction for Health Facility Staff Training modules available for our review focused on helping participants concretely learn what stigma is and what its consequences are (i.e., ...

10. iapac.org iapac.org/unmasking-stigma-mobilizing-resilience/

Unmasking Stigma, Mobilizing Resilience Evaluations of these programs have shown a measurable reduction in HIV stigma, including self-stigma, among congregants. Digital ...