Testing a new monthly HIV prevention medication

Plain-English translation of NCT07044297 on ClinicalTrials.gov ↗ · Source last updated August 2026 · Translation generated July 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing a new HIV prevention medication called , given as a monthly injection or pill. Researchers want to know if it works as well as or better than the standard daily HIV prevention pill (), and whether it is safe and well-tolerated. The study will enroll about 4,390 people over approximately 2 years.

Current HIV prevention requires taking a pill every single day, which can be hard for some people to stick with. This medication is designed to work with monthly dosing instead, which may make it easier for people to use HIV prevention consistently.

Do you qualify?

You likely qualify if…

you are confirmed to be HIV-negative based on recent blood tests
you are a cisgender man, transgender woman, transgender man, or gender nonbinary person
you have had condomless anal sex in the past year outside of a monogamous relationship, plus at least one additional risk factor (multiple partners, recent sexually transmitted infections, or drug use with sex)
you weigh at least 77 pounds (35 kg)

You likely don't qualify if…

you have an allergy or intolerance to any of the study medications
you have chronic hepatitis B infection
you have a history of cancer in the past 5 years (except certain skin cancers)
you have previously taken long-acting HIV prevention medications like cabotegravir or lenacapavir
you received an HIV vaccine or HIV antibody treatment in the past 12 months

What participation looks like

You will be randomly assigned to receive either the new monthly medication or the standard daily pill for about 2 years. You'll take or receive your assigned treatment and attend study visits to have blood tests and check-ins about your health and any side effects. After the main study period ends, everyone will receive the standard daily pill for an additional 28 days to ensure ongoing protection.

AI-generated summary from trial data · Jul 16, 2026 · Not medical advice

Trial locations(81 sites)

United States

University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006), Birmingham, Alabama

USA Health University Hospitals ( Site 0020), Mobile, Alabama

UCLA Center for Clinical AIDS Research and Education ( Site 0004), Los Angeles, California

Bridge HIV - San Francisco Department of Public Health ( Site 0001), San Francisco, California

Whitman-Walker Institute ( Site 0016), Washington D.C., District of Columbia