Long-Acting HIV Prevention Tools

What Are Long-acting HIV Prevention Tools?

Long-acting HIV prevention tools are new long-lasting forms of HIV prevention being studied by researchers. These are HIV prevention tools that do not require daily dosing. Instead, they can be inserted, injected, infused, or implanted in a person’s body from once a month to once a year to provide sustained protection from acquiring HIV.

Why Are Long-acting HIV Prevention Tools Needed?

Currently, people who are HIV-negative but at risk for HIV can lower their chances of getting HIV by taking HIV prevention medicine as prescribed. This is called pre-exposure prophylaxis (PrEP). When taken daily, oral PrEP pills can stop HIV from taking hold and spreading throughout your body. These pills are highly effective when taken daily as prescribed. However, studies have shown that PrEP is much less effective if it is not taken consistently, and that taking a daily pill can be challenging for some people.

That’s why researchers are working to create new HIV prevention tools that do not require taking a daily pill.

Scientists funded by the National Institutes of Health (NIH) are developing and testing several long-acting forms of HIV prevention that can be inserted, injected, infused, or implanted in a person’s body from once a month to once a year. The goal of this research is to provide people with a variety of acceptable, discreet, and convenient choices for highly effective HIV prevention. Currently, only one form of long-acting injectable PrEP has been approved by the U.S. Food and Drug Administration (FDA). But research continues on other forms of PrEP and they might become available in the not-too-distant future.

What Types of Long-acting HIV Prevention Tools Are Under Study?

Four types of long-acting HIV prevention are in development and testing in research studies: intravaginal rings, injectable drugs, implants, and antibodies.

Intravaginal rings for women. Long-acting intravaginal rings are polymer-based products that are inserted into the vagina, where they continuously release one or more antiretroviral drugs over time. The intravaginal ring at the most advanced stage of research is the dapivirine ring, which was tested in two large clinical trials, including the NIH-funded ASPIRE study. This study and another trial called The Ring Study found that the dapivirine ring reduced the risk of HIV acquisition by roughly 30% in women ages 18 to 45 years and was well-tolerated. In 2021, the World Health Organization (WHO) recommendedExit Disclaimer the ring as part of combination prevention approaches for women at substantial risk for acquiring HIV. If approved by regulatory agencies, the monthly ring would provide women in developing countries with a discreet long-acting HIV prevention option that they control. (Learn more.)

Injectables. Injectables are select long-acting antiretroviral drugs that are injected into the body. Injectables are being studied for both HIV prevention and HIV treatment. Two large-scale clinical trials found that a long-acting form of the investigational antiretroviral drug cabotegravir injected once every eight weeks, was safe and more effective than daily oral PrEP at preventing HIV acquisition among both cisgender women and cisgender men and transgender women who have sex with men. At the end of 2021, the FDA approved this long-acting form of cabotegravir (Apretude) as the first and only long-acting injectable form of PrEP. (Learn more.)

Implants. Long-acting implants are small devices that are implanted in the body and release an anti-HIV drug at a controlled rate for continuous protection from HIV over time. NIH, among others, is funding the development and testing of several of these implants for HIV prevention. Most of these products are at an early stage of development and have not yet been tested in humans. Studies supported by other funders are exploring an implant for women that protects users from both HIV and unplanned pregnancy.

Antibodies. Scientists have begun to test whether giving people periodic infusions of powerful anti-HIV antibodies can prevent or treat HIV. The antibodies involved can stop a wide variety of HIV strains from infecting human cells in the laboratory and thus are described as “broadly neutralizing antibodies” (bNAbs). Two advanced NIH-funded clinical trials are assessing whether giving infusions of bNAbs to healthy men and women at high risk for HIV protects them from acquiring the virus. Several early-stage clinical trials of other bNAbs for HIV prevention also are underway.

For a visual illustration of NIH’s long-acting HIV prevention research portfolio, see this infographic.

Can I Use Long-acting HIV Prevention Tools Now?

At this time, only Apretude, the long-acting injectable form of PrEP described above, has been approved by the FDA and is available for your doctor to prescribe for you. Other forms of long-acting HIV prevention are being tested in clinical trials. Researchers are also investigating a range of multipurpose prevention technologies that aim to reduce the risk of HIV and STIs and/or provide effective contraception for women. Since the effectiveness of these other long-acting forms of HIV prevention has not yet been proven, they have not been considered for approval by the FDA. So, they are not available for your doctor to prescribe yet. However, NIH-supported clinical trials may be seeking volunteers to participate in some studies on long-acting HIV prevention tools. You may be eligible to participate in one of these trials. Information can be found at ClinicalTrials.gov or by calling (800) 411-1222.

It may be several years before other long-acting HIV prevention tools are available to the public. In the meantime, the best forms of prevention against sexual transmission of HIV continue to be:

• HIV testing—so that you know your own HIV status and your partner’s.
• Antiretroviral therapy for people who have HIV, to protect their health and prevent transmitting the virus to their sexual partners. People with HIV who take HIV medication as prescribed and get and keep an undetectable viral load can live a long and healthy life and will not transmit HIV to their HIV-negative partners through sex. This is sometimes called treatment as prevention or “undetectable is untransmittable” (U = U).
• Daily oral PrEP or long-acting injectable PrEP for people who do not have HIV but are at risk of getting it.
• Using condoms consistently and correctly. (Learn the right way to use a male condom.)
• Choosing less risky sexual behaviors. HIV is mainly spread by having anal or vaginal sex without a condom or without taking medicines to prevent or treat HIV.
• Reducing the number of people you have sex with.
• Post-exposure prophylaxis, or PEP, meaning taking antiretroviral medicines very soon after being potentially exposed to HIV to prevent the virus from taking hold in your body.

The more of these actions you take, the safer you will be. To learn more about steps you can take now to prevent getting or transmitting HIV, read other pages in HIV.gov’s HIV Prevention section.

This page was developed in collaboration with NIH’s National Institute of Allergy and Infectious Diseases.