HIV Prevention Research Study
Researchers at UNC Chapel Hill are conducting a study on HIV prevention for people who could benefit from PrEP.
Fast Facts
Cis Male, Trans Man, Trans Woman, or Non-Binary Adults
Have Been Sexually Active With Males in The Past Year
Compensation
Provided
Conducted in
Chapel Hill, NC
Study Background
This study is testing whether a once-monthly pill (MK-8527) is a safe and effective alternative to daily PrEP.
Both FDA-approved oral forms of HIV prevention medication (PrEP) must be taken every day to be effective. While daily pills are highly protective, not everyone finds it easy to take them consistently. Researchers at UNC Chapel Hill are part of an international effort to study a new option: a once-monthly oral pill called MK-8527.
The EXPrESSIVE-11 study is enrolling cisgender men, transgender women and men, and non-binary people who could benefit from PrEP. By comparing once-monthly MK-8527 to the current standard daily pill (emtricitabine/tenofovir, also known as Truvada®), researchers hope to learn whether a monthly pill can be just as safe and effective at lowering the risk of acquiring HIV.
Study Background
This study is testing whether a once-monthly pill (MK-8527) is a safe and effective alternative to daily PrEP.
Both FDA-approved oral forms of HIV prevention medication (PrEP) must be taken every day to be effective. While daily pills are highly protective, not everyone finds it easy to take them consistently. Researchers at UNC Chapel Hill are part of an international effort to study a new option: a once-monthly oral pill called MK-8527.
The EXPrESSIVE-11 study is enrolling cisgender men, transgender women and men, and non-binary people who could benefit from PrEP. By comparing once-monthly MK-8527 to the current standard daily pill (emtricitabine/tenofovir, also known as Truvada®), researchers hope to learn whether a monthly pill can be just as safe and effective at lowering the risk of acquiring HIV.
Additional Information
This study is being done to see if a once-monthly pill (MK-8527) is a safe and effective option to help prevent HIV, compared to Truvada.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Cis male, trans man, trans woman, or non-binary adults
- Not living with HIV
- Have been sexually active with males in the past year
- Could benefit from PrEP
- Never received an HIV vaccine
- Willing and able to commit to monthly study visits involving blood and urine samples, questionnaires, and being tested for sexually transmitted infections
- Ages 18+
You’ll start with a phone screening and an in-person health screening to confirm eligibility.
If eligible, you’ll be randomized to take either the once monthly study pill (MK-8527) or daily FTC/TDF (Truvada). Both treatment assignments are placebo controlled.
You’ll come to regular study visits at UNC’s research clinic for health check-ups, blood and urine samples, and HIV/STI testing.
You’ll complete short health questionnaires and have phone check-ins between clinic visits.
Throughout the study, your health and safety will be monitored closely by the research team.
In the first year, this adds up to about $1,950. Additional help is available if you travel more than 50 miles, and Uber Health rides may be arranged if needed. Free blood work with results, snacks, and other retention incentives are also provided.
There is no cost for you to participate in our research study.