Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Implementation of Out-of-HOspital administration of the Long-Acting combination cabotegravir+rilpivirine as an optional therapy in HIV-Infected patients from Spain. Acceptability, appropriateness, feasibility and satisfaction. The HOLA Study.

This study, called HOLA, is exploring a new treatment option for people living with HIV in Spain. Instead of taking daily pills, participants will receive long-acting injections of two medicines, cabotegravir and rilpivirine, outside of a hospital setting. The main goal is to understand how much patients like this new injection method, how easy it is for them, and if it's a practical option. Researchers will also closely monitor the safety of this treatment, looking for any side effects and how well people tolerate the injections. Ultimately, this study aims to see if giving HIV treatment this way could be a good choice for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C, Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C

Enrolment target

110

Start

01 Aug 2023

HIV-Infected patients

What is this study about?

This study is looking into a new way to manage HIV called the HOLA Study. Traditionally, people with HIV take daily pills to keep the virus under control. However, this study is testing a different approach: using long-acting injections of two medicines called cabotegravir and rilpivirine.

The main idea is to see if these injections can be given to patients outside of a hospital, perhaps at home or in local clinics. The researchers want to find out how much patients like this new way of getting their treatment, if it fits into their lives easily, and how practical it is overall. They'll be asking people for their opinions on how acceptable and suitable this injection treatment is for them.

Another very important part of the study is to check how safe these injections are and how well people tolerate them. The researchers will be carefully looking for any side effects, whether they are minor or more serious, and how people react to the injections. This will help them understand if this treatment method is not only effective but also comfortable and safe for patients who choose it.

Key takeaways

New HIV treatment method: long-acting injections instead of daily pills.
Aims to study treatment given outside of a hospital.
Will assess patient satisfaction and ease of use.
Carefully monitors safety and side effects.
Participation lasts at least 12 months with regular check-ins.
You can leave the study whenever you wish.

Who may be eligible?

To take part in this study, you must be at least 18 years old. Both men and women are welcome to participate. The study is specifically designed for people who have HIV.

Further details about your health and medical history would be shared by your doctor to determine if this study is suitable for you. This ensures that the study is safe and appropriate for everyone 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 at least 18 years old?
Are you living with HIV?
Are you comfortable filling out questionnaires about your treatment?
Could you potentially receive injections outside of a hospital setting?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking part in what's called a 'Phase IV' study. This means the treatments being looked at are already approved, but researchers want to see how they work in real-world settings. You would receive two long-acting injections of medication, Vocabria (cabotegravir) and Rekambys (rilpivirine), along with some Edurant tablets. The specific schedule for these would be explained by the study team.

You would regularly be asked to complete questionnaires to share your thoughts on the treatment, particularly how much you like it and how easy it is to receive the injections. The study team will also monitor any side effects you might experience and how well your body tolerates the treatment. The total duration of your participation would be for at least 12 months, with check-ups and assessments at specific times like 1, 6, and 12 months.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as trying a new, convenient form of HIV treatment that could reduce the need for daily pills. However, there are also potential risks, including side effects from the medications, such as reactions at the injection site or other bodily responses. All serious side effects will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is the main goal of this study?

The study aims to see how acceptable, easy to use, and safe long-acting injectable HIV treatment is when given outside of a hospital setting.

What kind of treatment will I receive?

You will receive long-acting injections of two medicines, cabotegravir (Vocabria) and rilpivirine (Rekambys), and possibly some Edurant tablets.

How long will I be in the study?

Your participation will last at least 12 months, with checks and questionnaires at 1, 6, and 12 months.

Will I have to go to a hospital for treatment?

No, this study is specifically looking at giving the injections outside of a hospital.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your usual medical care.