Not yet recruitingPHASE3INTERVENTIONAL

Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.

This study, happening in France, is exploring a new way to prevent HIV called CAB-LA, which is an injection given every couple of months. It's for men who have sex with men (MSM) who are already using daily HIV prevention pills (oral PrEP). Researchers want to find out if offering this long-acting injection helps people keep up with their HIV prevention medicine over time and provides better protection during risky sexual activities. The study will compare those who switch to the injection with those who continue using the pills, tracking their progress over two years. It also looks at safety, sexual behaviours, and how well the prevention methods work.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

ANRS, Emerging Infectious Diseases

Enrolment target

322

Start

01 Apr 2024

Estimated completion

30 Oct 2026

Prevention

What is this study about?

This study is about finding new and better ways to help men who have sex with men (MSM) prevent HIV. Many people currently use daily pills (known as oral PrEP) to protect themselves from HIV. While these pills are very effective, remembering to take them every day can be a challenge for some people.

Researchers are investigating a new long-acting injectable medicine called cabotegravir (CAB-LA). This medicine is given as an injection every couple of months, meaning you don't have to remember to take a pill every day. The study wants to see if offering this injection as an alternative to daily pills can help people stick with their HIV prevention plan more consistently and provide better protection during sexual activity that might carry a risk of HIV.

Participants in the study will either continue with their current daily pills or switch to the new injection. Researchers will then compare these two groups to see which method leads to more consistent use and better protection over two years. They will also look at safety, any changes in sexual behaviour, and how well each method prevents HIV. Understanding these factors will help doctors decide if CAB-LA should be more widely available as an option for HIV prevention.

Key takeaways

This study compares a new long-acting HIV prevention injection (CAB-LA) with daily prevention pills (oral PrEP).
It's for adult men who have sex with men (MSM) who are already using oral PrEP in France.
The main goal is to see if the injection helps people stick with HIV prevention better over two years.
Participants will either continue with pills or switch to the injection; this choice is made randomly.
The study also looks at safety, sexual behaviours, and how well the prevention methods work.
Your participation helps improve HIV prevention options for others.

Who may be eligible?

To join this study, you need to be an adult man (at least 18 years old) who has sex with men. You must have been taking daily HIV prevention pills (called TDF/FTC PrEP) for at least six months, whether you took them every day or just when needed.

There are also some health conditions that would prevent you from joining. For example, you can't participate if you currently have HIV or signs of a recent HIV infection. You also can't have certain ongoing health problems like severe liver issues, kidney problems, some skin conditions that make injections difficult, or if you take certain medications that might react badly with the study drugs. The researchers will do health checks to make sure it's safe for you to take part.

Finally, you need to be connected to France's social security system, agree to be contacted by phone or email, and give your written permission (consent) to join the study after understanding everything involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you a man who has sex with men?
Have you been taking daily HIV prevention pills (TDF/FTC PrEP) for at least 6 months?
Do you currently not have HIV and don't have signs of recent HIV infection?
Do you have good kidney and liver health, and no major bleeding disorders, severe skin conditions, or certain allergies?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to either continue with your current daily HIV prevention pills (TDF/FTC PrEP) or switch to the new long-acting injectable medicine (CAB-LA). This is like flipping a coin to decide which group you're in, and neither you nor the researchers get to choose.

If you're in the injection group, you'll receive your medicine as injections every couple of months. Both groups will have regular check-ups with the study team, which will include blood tests, health assessments, and discussions about your sexual health and how you're feeling. Some participants will also be asked to take part in focus groups to share their experiences and thoughts about the prevention methods.

The entire study will involve visits over two years. Before you start, you'll have an initial assessment, and then you'll be followed up regularly for 24 months. During this time, the study team will monitor your health, how well the prevention method is working, and any side effects. You are free to stop participating at any time.

Potential risks and benefits

By taking part in this study, you might benefit from closer medical monitoring and access to a newer HIV prevention option (CAB-LA) which could be more convenient than daily pills. For some, the long-acting injection might make it easier to consistently prevent HIV. However, like any medicine, both the pills and the injection have potential side effects. These could include things like headache, feeling sick, or tenderness at the injection site. There's also the chance that the new injection might not work as well for you as your current pills, or that you might discover health issues during the study that you weren't aware of. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Hôpital Hôtel Dieu
Verified postcode
Paris, France
Hôpital Lariboisière
Verified postcode
Paris, France
Hôpital Saint Louis
Verified postcode
Paris, France
Hôpital Saint Antoine
Verified postcode
Paris, France
Hôpital La Pitié Salpêtrière
Verified postcode
Paris, France
Hôpital Necker
Verified postcode
Paris, France
Hôpital Bichat
Verified postcode
Paris, France
Hôpital Tenon
Verified postcode
Paris, France

Common questions

What is PrEP?

PrEP stands for Pre-Exposure Prophylaxis. It's a medicine taken by people who don't have HIV to prevent them from getting it.

What is CAB-LA?

CAB-LA is a new type of HIV prevention medicine that is given as an injection, rather than a daily pill.

Who is funding this study?

The study was designed and initiated by the researchers and is supported by public health grants in France.

Will I know if I'm getting the injection or staying on pills?

Yes, this is an 'open-label' study, meaning you will know which treatment you are receiving (the injection or the pills).

What if I get HIV during the study?

The study team will monitor you closely for HIV. If you do get HIV, they will help ensure you receive appropriate medical care, though the study is not designed to treat HIV.

How to find out more

Geoffroy LIEGEON, Dr

geoffroy.liegeon@aphp.fr 312-483-6988 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.