HIV Prevention Research Study
Researchers at Cone Health RCID Research are conducting a study on a once-monthly HIV prevention pill for individuals at higher risk of HIV-1 infection.
Fast Facts
Identify as Cisgender Men, Transgender Women, Transgender Men, or Gender Nonbinary Individuals
Ages 16+ & Have Had Condomless Receptive Anal Sex in the Past 12 Months
Compensation
Provided
Conducted in
Greensboro, NC
Study Background
Exploring a simpler, effective way to prevent HIV.
The MK-8527-011 study is evaluating a new once-monthly oral medication, MK-8527, to determine whether it is safe and effective in preventing HIV-1 infection. While daily pills and long-acting injections are already approved and available, not everyone finds these options easy to maintain. Researchers hope this new approach can simplify HIV prevention and make it more accessible to more people.
Participants in this study will be randomly assigned to take either the study drug MK-8527 or a currently approved daily medication. No one—including participants or research staff—will know which one is being given. Over the course of about 30 months, participants will attend monthly in-person clinic visits to receive medication, get tested for HIV, monitor overall health, and answer questions about their experiences.
Study Background
Exploring a simpler, effective way to prevent HIV.
The MK-8527-011 study is evaluating a new once-monthly oral medication, MK-8527, to determine whether it is safe and effective in preventing HIV-1 infection. While daily pills and long-acting injections are already approved and available, not everyone finds these options easy to maintain. Researchers hope this new approach can simplify HIV prevention and make it more accessible to more people.
Participants in this study will be randomly assigned to take either the study drug MK-8527 or a currently approved daily medication. No one—including participants or research staff—will know which one is being given. Over the course of about 30 months, participants will attend monthly in-person clinic visits to receive medication, get tested for HIV, monitor overall health, and answer questions about their experiences.
Additional Information
The study is testing whether a new once-a-month oral medication (MK-8527) is a safe and effective way to prevent HIV-1 infection in people at increased risk.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 16+
- Identify as cisgender men, transgender women, transgender men, or gender nonbinary individuals
- Have had condomless receptive anal sex in the past 12 months
- Have had 2+ partners in the past 3 months, or rectal/urethral gonorrhea or chlamydia, or incident syphilis in the last 6 months, or stimulant drug use with sex in the last 3 months
- Willing and able to attend monthly in-person visits for the study duration
Exclusion Criteria:
- Have a history of use of long-acting HIV prevention products (e.g., cabotegravir or lenacapavir) or received an HIV vaccine or monoclonal antibodies to HIV in the past 12 months
- Participating in another interventional study
- Pregnant or breastfeeding
Attend a screening visit to confirm eligibility
Be randomly assigned to receive either MK-8527 or a daily HIV prevention pill
Visit the study clinic in person each month for about 30 months
Receive medication, HIV testing, lab work, and health checkups at each visit
Answer questions about your health and experience throughout the study
Yes, participants will be compensated for their time.
You’ll also receive:
Free lab work with access to your results
Snacks on fasting lab days
Access to a 24/7 nurse line for research-related questions
Transportation support via Uber or Lyft if needed
A confidential, comfortable experience in a private clinic setting
There is no cost for you to participate in our research study.