Integrated Strategy for PrEP Uptake in HIV Prevention

Overseen By Theresa Gamble, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: HIV Prevention Trials Network

Must be taking: PrEP

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to increase the use of PrEP, a medication that helps prevent HIV, and improve viral suppression rates among Black men who have sex with men (MSM) in the southern United States. It tests an integrated approach that includes intersectional stigma reduction, peer support (such as peer counseling and peer support groups), and social media influencers to determine if these strategies encourage more people to use PrEP and manage HIV effectively. Participants are divided into two groups: one receives standard HIV care, while the other benefits from the new integrated strategy. Black men who have had sex with other men and currently live in the community of interest might be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies that could significantly improve HIV prevention and care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing the use of PrEP and does not mention any medication restrictions.

What prior data suggests that this integrated strategy is safe for increasing PrEP uptake and viral suppression among Black MSM?

Research has shown that strategies like reducing stigma and providing peer support are well-received by participants. For instance, support groups led by peers have successfully reduced stigma while boosting confidence and health. These group settings help individuals feel more understood and supported.

One study explored using social networks to encourage HIV testing among men who have sex with men in Ghana. This method received positive feedback, demonstrating that community-based strategies can be safe and effective.

Efforts to increase demand for PrEP (a medicine to prevent HIV) have also been studied. These initiatives often focus on raising awareness and understanding, which are generally safe and have no physical side effects.

Overall, these strategies emphasize social and emotional support. They do not involve taking new drugs or undergoing medical procedures, making them generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a fresh, integrated strategy for HIV prevention among Black MSM (men who have sex with men). Unlike traditional methods, which often focus solely on providing standard HIV prevention services, this approach combines intersectional stigma reduction, peer support, and social media influencers. By addressing stigma and leveraging community and online support, the strategy aims to enhance PrEP uptake and HIV prevention more effectively. This holistic approach is promising because it not only targets individual behavior but also seeks to create supportive environments that encourage healthier choices.

What evidence suggests that this trial's treatments could be effective for increasing PrEP uptake and viral suppression among Black MSM?

This trial will compare an Integrated Strategy with standard-of-care for HIV prevention among Black MSM (men who have sex with men) in the southern U.S. Studies have shown that stigma can prevent people from using HIV prevention tools like PrEP (pre-exposure prophylaxis). Research suggests that reducing stigma through community support and personal connections can help more people feel comfortable getting tested and using PrEP. The Integrated Strategy in this trial includes components such as social media influencers and peer support, which have effectively encouraged people to take steps for better HIV prevention. Past efforts using these strategies have successfully improved HIV-related health outcomes in similar communities. Overall, these approaches aim to create a supportive environment that encourages the use of HIV prevention and care services. ^{1 4 5 6 7}

Who Is on the Research Team?

Chris Beyrer, MD

Principal Investigator

Johns Hopkins University

LaRon Nelson, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for Black men, including cisgender and transgender, who have had sexual relations with other men. Participants must be at least 15 years old, live in the study area, and consent to a questionnaire and blood tests. HIV status doesn't matter for joining.

Inclusion Criteria

I have had sexual relations with other men in my lifetime.

I identify as a Black man, including if I am transgender.

Are willing and able to provide informed consent

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the integrated strategy to increase PrEP uptake and viral suppression among Black MSM

3 years

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Intersectional Stigma Reduction
• Peer Support
• Social Media Influencers

Trial Overview The study is testing an approach that combines health equity efforts, stigma reduction strategies, standard care enhancements, social media influencer involvement, and peer support to improve PrEP use and viral suppression among Black MSM in the South.

How Is the Trial Designed?

Group I: Standard-of-care Experimental Treatment 1 Intervention

Black MSM living in standard-of-care communities will have access to standard HIV prevention and care services available in their communities.

Group II: Integrated Strategy Experimental Treatment 4 Interventions

Black MSM living in intervention communities will have access to the HPTN 096 integrated strategy in addition to standard HIV prevention and care services available in their communities. The integrated strategy includes a combination of four community-, organizational-, and interpersonal-level components designed to impact individual-level outcomes.

Who Is Running the Clinical Trial?

HIV Prevention Trials Network

Lead Sponsor

Trials

31

Recruited

569,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Collaborator

Trials

4

Recruited

5,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8629287/

Multi-level intersectional stigma reduction intervention to ... Determining the feasibility and acceptability of multi-level intervention of reducing intersectional stigma and estimating its efficacy on increasing HIV ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10879468/

The development of a conceptual framework on PrEP stigma ... Stigma is a well‐known barrier to HIV testing and treatment and is an emerging barrier to pre‐exposure prophylaxis (PrEP) use.

3. sites.temple.edu sites.temple.edu/turiskcommlab/projects/

Projects – Temple University Risk Communication Laboratory Findings will advance the understanding of intersectional stigma and discrimination, highlight their health effects on justice-involved individuals with co- ...

4. formative.jmir.org formative.jmir.org/2024/1/e52842/

Adaptation and Reach of a Pre-Exposure Prophylaxis Social ... Social marketing interventions have demonstrated effectiveness in improving other HIV-related outcomes among Latino/a/x sexual minority men and ...

5. researchgate.net researchgate.net/publication/356618798_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

Multi-level intersectional stigma reduction intervention to ... Determining the feasibility and acceptability of multi-level intervention of reducing intersectional stigma and estimating its efficacy on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12256081/

PrEP Awareness & Demand Creation This paper focuses on consumer factors, how individuals' perceptions of PrEP, especially among those most likely to benefit, influence its uptake.

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

Unmasking Stigma, Mobilizing Resilience Peer-led support groups have consistently been shown to reduce internalized stigma, foster self-efficacy, and improve health outcomes. One such ...