Stigma-Reduction Intervention for HIV Prevention

Overseen By Rodman Turpin, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: George Mason University

Must be taking: PrEP

Disqualifiers: HIV positive, refusal of HIV testing

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

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce HIV stigma and encourage the use of PrEP (a pill to prevent HIV) in the community. Participants will attend events focused on stigma reduction and peer support through the MPowerment Stigma-reduction Intervention. The trial will compare participants in these activities with those receiving standard information to determine if there's an increase in starting and adhering to PrEP. It is well-suited for Black, HIV-negative men living in or connected to Prince George's County, MD. As an unphased trial, this study provides a unique opportunity to contribute to community health and support efforts to reduce HIV stigma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for participants?

Previous studies have shown that the MPowerment Stigma-reduction Intervention is safe for participants. This program aims to reduce risky sexual behavior and increase HIV testing, particularly among young men who have sex with men (MSM). Research indicates that participants experience positive behavioral changes without major safety concerns. The intervention is generally well-received by participants. The reviewed studies reported no significant harmful effects, supporting the safety of this approach for reducing HIV stigma and increasing the use of PrEP (pre-exposure prophylaxis). ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MPowerment Stigma-reduction Intervention stands out because it targets the social stigma surrounding HIV prevention, which is often a barrier to using pre-exposure prophylaxis (PrEP). Unlike standard care that merely provides referrals and resources, this intervention actively engages participants in activities designed to reduce stigma and boost support, making it easier for individuals to consider and start using PrEP. Researchers are excited about this approach because it addresses the psychological and social factors influencing HIV prevention, potentially leading to higher PrEP adoption rates and better overall outcomes in HIV prevention.

What evidence suggests that the MPowerment Stigma-reduction Intervention is effective for increasing PrEP initiation?

Research has shown that programs like the MPowerment Stigma-reduction Intervention, which participants in this trial may receive, can help reduce the stigma around HIV. Studies have found that these programs often lead to better outcomes in preventing and managing HIV. For example, they encourage more open discussions about HIV and increase the use of PrEP, a medication that helps prevent HIV. A review of several studies found that these programs can help people adhere to PrEP, especially in vulnerable groups. One study pointed out that while challenges exist, particularly related to race and sexuality, these programs have generally been successful. Early data suggest that reducing stigma is a promising way to increase PrEP use and help prevent HIV. ^{1 5 6 7 8}

Who Is on the Research Team?

Rodman Turpin, PhD

Principal Investigator

George Mason University

Are You a Good Fit for This Trial?

This trial is for HIV-negative, Black sexual minority men who are 18 or older. Participants must live in Prince George's County, Maryland, or have had a sexual partner there within the past year. Those who are HIV positive or refuse HIV testing cannot join.

Inclusion Criteria

You do not have HIV.

I am male.

You live in Prince George's County, Maryland, or have had a sexual partner from there in the past year.

Exclusion Criteria

HIV Positive

Refusal of HIV testing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in peer-based community intervention events focused on reducing internalized homophobia, racism, and HIV stigma, and increasing social support to boost PrEP initiation.

4-8 weeks

Multiple community events (in-person)

Follow-up

Participants are monitored for PrEP initiation and adherence, with blood spot tests conducted to assess adherence.

6 months

1 visit (mail-in blood spot test)

What Are the Treatments Tested in This Trial?

Interventions

• MPowerment Stigma-reduction Intervention

Trial Overview

The study tests a peer-based community intervention aimed at reducing stigma and increasing support among Black queer men to encourage PrEP use for preventing HIV. It will compare those receiving the intervention with a control group to assess differences in starting and sticking with PrEP.

How Is the Trial Designed?

Group I: MPowerment PrEP Promotion Intervention Experimental Treatment 1 Intervention

This is the arm engaging in the stigma-reduction and support-increasing activities aimed to increase PrEP use.

Group II: Standard of Care Active Control 1 Intervention

This is the arm not engaging in the stigma-reduction and support-increasing activities. This arm will receive standard referreals to PrEP knowledge resources and providers.

Who Is Running the Clinical Trial?

George Mason University

Lead Sponsor

Trials

60

Recruited

50,200+

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]

Stigma surrounding HIV significantly affects both individuals living with HIV and those who could benefit from prevention services, and it is crucial to analyze how stigma is perpetuated within healthcare service delivery systems.

The commentary emphasizes the need for new strategies to reduce stigma in HIV service implementation, advocating for stigma reduction to be a core outcome in research and evaluation to improve health equity for affected populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognizing and disrupting stigma in implementation of HIV prevention and care: a call to research and action. Golub, SA., Fikslin, RA.[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]

The systematic review identified 11 effective interventions that reduce HIV stigma among men who have sex with men (MSM), highlighting the importance of addressing both internalized and anticipated stigma through various strategies.

Interventions were categorized into three mechanisms: intrapersonal strategies (like education), interpersonal strategies (such as peer support), and structural strategies (community sensitization), all of which work together to promote self-acceptance and social empowerment, ultimately improving HIV prevention and care engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A realist systematic review of stigma reduction interventions for HIV prevention and care continuum outcomes among men who have sex with men. Dunbar, W., Labat, A., Raccurt, C., et al.[2021]

A new HIV Stigma Scale was developed and validated using responses from 318 individuals with HIV, demonstrating strong reliability and validity in measuring perceived stigma.

The scale identified four key factors related to stigma: personalized stigma, disclosure concerns, negative self-image, and public attitudes, which are important for understanding the psychosocial impact of living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring stigma in people with HIV: psychometric assessment of the HIV stigma scale. Berger, BE., Ferrans, CE., Lashley, FR.[2022]

The study aims to develop a multi-level intervention to reduce intersectional stigma faced by men who have sex with men (MSM) in Ghana, which is crucial for improving HIV testing rates among this population.

By conducting a cluster randomized controlled trial with 216 MSM participants, the research will assess the effectiveness of combined stigma-reduction strategies at different levels (health care facility, peer group, and individual) in increasing HIV testing uptake over 3 and 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-level intersectional stigma reduction intervention to increase HIV testing among men who have sex with men in Ghana: Protocol for a cluster randomized controlled trial. Nelson, LE., Nyblade, L., Torpey, K., et al.[2022]

The community intervention in South Africa effectively reduced HIV stigma among people living with HIV (PLWH) and those close to them, enhancing relationships and increasing willingness to disclose HIV status.

Participants reported improved knowledge about stigma and coping strategies, empowering them to lead stigma reduction efforts in their communities, indicating a positive impact on community awareness and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive HIV stigma-reduction and wellness-enhancement community intervention: a case study. French, H., Greeff, M., Watson, MJ., et al.[2015]

The Mpowerment-based community intervention significantly improved psychosocial factors such as social diffusion of safer sex messages and comfort with being gay among young black MSM over 4 years, indicating its effectiveness in reducing HIV risk behaviors.

While the intervention showed positive effects on social diffusion and depressive symptoms, it also highlighted challenges, as participants reported less favorable attitudes towards condom use and difficulties in sexual situations, suggesting a need for a more comprehensive approach to address broader health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Community-Level HIV Prevention Intervention on Psychosocial Determinants of HIV Risk Behaviors among Young Black Men Who Have Sex with Men (YBMSM). Eke, AN., Johnson, WD., O'Leary, A., et al.[2022]

The Mpowerment (MP) intervention significantly increased HIV testing and self-efficacy for safer sex among 298 young men who have sex with men (MSM) of color over a 3-year period, indicating its effectiveness in promoting safer sexual behaviors.

Participants reported higher self-acceptance as MSM and improved perceptions of positive social norms regarding safer sex after the intervention, although the reduction in condomless anal/vaginal sex was only noted at the first follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Mpowerment on Individual-Level HIV Risk Behavior, Testing, and Psychosocial Factors Among Young MSM of Color: The Monitoring and Evaluation of MP (MEM) Project. Shelley, G., Williams, W., Uhl, G., et al.[2022]

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The intervention has been associated with statistically significantly increased engagement with discussions around HIV and uptake of PrEP (49,50) ...

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reporter.nih.gov

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mpowerment.org/wp-content/uploads/2017/02/aids_education_and_prevention_2017.pdf

an evaluation of mpowerment on

Mpowerment (MP) is an intervention designed to reduce risky sexual behavior and increase HIV testing among young MSM ages. 18–29. From 2009 to 2012, three ...