Integrated Stigma Reduction Interventions for HIV/AIDS

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

840 Participants Needed

Trial Summary

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.

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

Research shows that interventions aimed at reducing HIV stigma can be effective, at least in the short term, and participation in mental health services integrated with HIV care has been associated with reduced perceived stigma. This suggests that the integrated stigma reduction interventions in the trial may help decrease stigma for people living with HIV/AIDS. ^{1 2 3 4 5}

How does the Integrated Stigma Reduction Interventions for HIV/AIDS treatment differ from other treatments?

This treatment is unique because it combines multiple family group sessions and educator group sessions to specifically target and reduce stigma associated with HIV/AIDS, which is not typically addressed in standard HIV treatments. It focuses on improving social support and reducing discrimination, which can enhance the overall well-being and health service engagement of individuals living with HIV. ^{1 3 4 6 7}

What is the purpose of this trial?

M-Suubi, a three arm cluster randomized study will examine the effects and cost-effectiveness of a multi-level intervention on HIV viral suppression among 840 adolescents living with HIV (ALHIV) enrolled in 42 secondary schools with a boarding section. The investigators will test the effects of a group-based HIV stigma reduction intervention for educators (GED-HIVSR), over and above the effects of multiple family groups with HIV stigma reduction combined with family economic empowerment (MFG-HIVSR plus FEE), relative to Bolstered Standard of Care (BSOC). ALHIV will be randomized at the school level to one of three study arms

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Perceived stigma reductions following participation in mental health services integrated within community-based HIV primary care. [2022]

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

Experiences of social stigma and implications for healthcare among a diverse population of HIV positive adults. [2022]

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

Measurement of stigma in people with HIV: a reexamination of the HIV Stigma Scale. [2022]

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

Interventions to reduce HIV/AIDS stigma: what have we learned? [2022]

5. England pubmed.ncbi.nlm.nih.gov

Quality of life in people living with HIV in Aotearoa New Zealand: an exploratory cross-sectional study. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Editorial: Global action to reduce HIV stigma and discrimination. [2022]

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

[EXPERIENCES RELATED TO AN INTERVENTION TO REDUCE STIGMA RELATED TO HIV / AIDS AMONG MEDICAL STUDENTS IN PUERTO RICO]. [2023]