Healthcare and Medical News for Atlanta Physicians

HIV Prevention Clinical Trial in Atlanta Enrolling Now

By Colleen Kelley, MD

Colleen Kelley, MD
Dr. Colleen Kelley

Human immunodeficiency virus (HIV) remains a major public health challenge in the United States.1 Approximately 1.2 million people in the U.S. are living with HIV, and an estimated 13% do not know they have it.2 The Atlanta metro area had the third-highest rate of new HIV diagnosis among U.S. metro areas in 2021, accounting for more than half of all new HIV diagnoses in Georgia that year.3

Daily oral pre-exposure prophylaxis (PrEP) can be highly effective to help prevent HIV when taken consistently and before exposure.4 However, adherence to a daily, oral prevention regimen remains challenging for many people who could benefit from PrEP, limiting its real-world impact.5 Adherence to a daily pill for people without HIV can be affected by many barriers, including routine burden, perceived risk and stigma.6 People who would benefit from PrEP continue to express interest in less frequent dosing prevention options.6 Longer acting agents that do not require daily dosing have significant potential to improve HIV prevention efforts and reduce new infections.7

A clinical trial that is evaluating an investigational, monthly oral PrEP medication for people who may be exposed to the virus is currently recruiting eligible participants in Atlanta.

Healthcare providers are often a critical point of connection for people who may benefit from HIV prevention services.8 By routinely discussing PrEP and sexual health, asking about adherence barriers without judgment and sharing information about clinical research opportunities when appropriate, providers can help ensure patients are aware of the full range of prevention options available to them.8

A Clinical Trial to Evaluate a Monthly Investigational Medicine for PrEP

MK-8527, an investigational, once-monthly oral PrEP candidate, is being evaluated in EXPrESSIVE-011 (NCT07044297), a Phase 3, randomized, active-controlled, double-blind clinical trial taking place at the Hope Clinic of the Emory Vaccine Center. The study is designed to evaluate the efficacy, safety and tolerability of once-monthly oral MK-8527 compared with daily emtricitabine/tenofovir disoproxil fumarate.

Key inclusion criteria include, but are not limited to, the following:

  • At least 16 years of age
  • Do not have HIV
  • Are a cisgender man (assigned male at birth and identify as male), transgender woman (assigned male at birth and identify as female), transgender man (assigned female at birth and identify as male), or gender nonbinary (assigned any gender at birth and do not identify as exclusively male or female)
  • Have had receptive anal sex without a condom in the past year (not counting sex in a committed relationship) and have at least 1 of these situations:
    • Had receptive anal sex with 2 or more partners in the last 3 months, no matter if you used a condom or not
    • Had rectal or urethral infections like gonorrhea, chlamydia, or syphilis in the last 6 months
    • Used any stimulant drugs while having sex in the last 3 months

Additional eligibility criteria will be assessed by the study investigator. The study lasts for up to 30 months (around 2.5 years), and participants will attend monthly study clinic visits. There may be risks related to participation in clinical research, which the study team can discuss with people who may be interested in participating.

The Importance of Representation in HIV Prevention Research

Anyone can get HIV, regardless of race, gender or sexual orientation.9 However, the burden of new infections remains unevenly distributed across communities in the U.S., including in Atlanta.3,10

Black and Hispanic/Latino communities are disproportionately affected across the U.S, as Black people make up about 12% of the U.S. population but account for 38% of new HIV infections, while Hispanic/Latino people represent about 18% of the population but account for 34% of new infections.10 In addition, gay, bisexual and other men (including teens and adults) who have sex with men accounted for about 67% of new HIV diagnoses in the U.S. in 2022.11

In Atlanta and across the South, longstanding social and structural inequities continue to shape diagnosis rates and access to prevention.12 As Atlanta consistently maintains one of the highest HIV diagnosis rates among major U.S. metropolitan areas, this underscores the need for prevention strategies and clinical research that reflect the communities most affected.12

Representation in HIV prevention trials is essential for emerging options to be evaluated in the populations who will benefit the most. Healthcare providers can play a critical role by addressing barriers to participation, fostering trust and helping people understand whether a clinical trial may be an option for them.8

Learn More

Learn more about the MK-8527-011 trial and see if you have patients who may qualify at https://www.merckclinicaltrials.com/HIV.

References

  1. Ekarika E, Iheagwara C, Amadi AT, et al. Social Determinants and Prevention Strategies in the HIV Epidemic: The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Database Analysis. Cureus. 2025;17(5):e84456. Published 2025 May 20. doi:7759/cureus.84456.
  2. HIV.gov. U.S. statistics. Updated February 25, 2026. Accessed July 2026. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics.
  3. Morehouse School of Medicine. New HIV Case Rate in Metro Atlanta Third Highest in Nation. Accessed July 2026. https://www.msm.edu/RSSFeedArticles/2024/April/Atlanta-HIV-Rate.php.
  4. HIV.gov. Pre-exposure prophylaxis (PrEP). Updated June 18, 2025. Accessed July 2026. https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis.
  5. Hojilla JC, Hurley LB, Marcus JL, et al. Characterization of HIV Preexposure Prophylaxis Use Behaviors and HIV Incidence Among US Adults in an Integrated Health Care System. JAMA Netw Open.2021;4(8):e2122692. doi:1001/jamanetworkopen.2021.22692.
  6. Wood S, Gross R, Shea JA, et al. Barriers and Facilitators of PrEP Adherence for Young Men and Transgender Women of Color. AIDS Behav. 2019 Oct;23(10):2719-2729. doi: 10.1007/s10461-019-02502-y.
  7. HIV.gov. Long-Acting HIV Prevention Tools. Accessed July 2026. https://www.hiv.gov/hiv-basics/hiv-prevention/potential-future-options/long-acting-prep.
  8. CDC.gov. Provider Resources. Last updated January 29, 2025. Accessed July 2026. https://www.cdc.gov/high-quality-care/hcp/resources/provider.html.
  9. HIV.gov. Who is at risk for HIV? Accessed July 2026. https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/who-is-at-risk-for-hiv.
  10. amfAR. HIV/AIDS in the U.S. Updated February 2026. Accessed July 2026. https://www.amfar.org/about-hiv-aids/hiv-aids-in-the-us/.
  11. HIV.info.NIH.gov. HIV and gay and bisexual men. Last reviewed March 20, 2026. Accessed July 2026. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-and-gay-and-bisexual-men.
  12. Piske M, Nosyk B, Smith JC, Yeung B, Enns B, Zang X, et al. Ending the HIV epidemic in metropolitan Atlanta: a mixed-methods study to support the local HIV/AIDS response. J Int AIDS Soc. 2024;27:e26322. doi:1002/jia2.26322.

Colleen Kelley, MD Colleen Kelley, MD

Dr. Colleen Kelley, Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Associate Dean for Research, has a multi-disciplinary background and previous clinical and research experience in HIV treatment and prevention, HIV epidemiology and clinical trials, and laboratory-based HIV research.

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