RecruitingPhase 3NCT05515770

The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir

An Implementation Study of Long-acting Injectable Cabotegravir (CAB-LA) for HIV Pre-Exposure Prophylaxis (PrEP) Among Young MSM, Non-binary and Transgender Persons (The ImPrEP CAB Study)


Sponsor

Evandro Chagas National Institute of Infectious Disease

Enrollment

1,200 participants

Start Date

Sep 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Although CAB LA PrEP has been proven efficacious in blinded randomized controlled clinical trials, additional research is needed to evaluate effectiveness in real world settings as well as to identify effective implementation strategies. The proposed implementation study will assess the safety and effectiveness of open label CAB LA PrEP when offered at public health facilities to cisgender men and transgender or gender non-binary individuals who have sex with persons assigned male at birth. The study will also evaluate two nested implementation strategies, an mHealth education and decision support tool and a WhatsApp injection appointment reminder. The study will also assess overall facilitators and barriers to integrating CAB LA into existing oral PrEP services.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how well a long-acting injectable HIV prevention drug (cabotegravir, given as a shot every 2 months) called CAB-LA is used in real-world clinical settings for young men (18–30) who are at risk of HIV through anal sex. This type of drug is called PrEP (pre-exposure prophylaxis) — it prevents HIV infection before it occurs. **You may be eligible if...** - You are a cisgender man, non-binary person assigned male at birth, or transgender woman or man, aged 18–30 - You have had anal sex with a person assigned male at birth in the last 6 months - You are seeking PrEP at a study clinic - You are HIV-negative and have not previously taken CAB-LA or standard PrEP pills - You are willing to attend follow-up visits and complete study requirements **You may NOT be eligible if...** - You already have HIV - You are 31 years or older, or younger than 18 - You have previously used CAB-LA or TDF/FTC PrEP - You have significant liver disease - You are not seeking PrEP (not at risk or not interested in prevention) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabotegravir Injection

Long action cabotegravir injection


Locations(1)

Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ

Rio de Janeiro, Brazil

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NCT05515770


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