Using injectable Cabotegravir for HIV prevention

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)

This study is testing if an injectable HIV prevention medication called Cabotegravir is safe and effective for cisgender men and transgender or gender non-binary individuals who have sex with men, while also trying out new ways to help people remember their injection appointments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 18 Years to 30 Years
• Sex: Male
• Sponsor: Evandro Chagas National Institute of Infectious Disease (Academic / other)
• Locations: 1 site (Rio de Janeiro)
• Trial ID: NCT05515770 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of injectable Cabotegravir as pre-exposure prophylaxis (PrEP) for HIV among cisgender men and transgender or gender non-binary individuals who have sex with persons assigned male at birth. It will be conducted in public health facilities in Brazil and will assess two implementation strategies: a mobile health education tool and a WhatsApp reminder for injection appointments. The study aims to identify barriers and facilitators to integrating Cabotegravir into existing oral PrEP services, addressing the rising HIV incidence in the region.

Who should consider this trial

Good fit: Ideal candidates include cisgender men, transgender women, and non-binary individuals aged 18-30 who have engaged in anal sex with persons assigned male at birth in the last six months.

Not a fit: Patients who do not engage in anal sex with persons assigned male at birth or those with existing HIV infections will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance HIV prevention strategies and access to PrEP for at-risk populations.

How similar studies have performed: Previous studies have shown success with oral PrEP, but this approach using injectable Cabotegravir is relatively novel and aims to expand access and effectiveness in real-world settings.

Eligibility criteria

Inclusion Criteria:

1. Cisgender men, non-binary (assigned as male at birth) or transgender women and men
2. Report having anal sex with a person assigned male at birth in the last six months (Persons born female having sex only with other persons born female are excluded)
3. Age 18-30 years
4. Seek a study clinic looking for PrEP
5. CAB LA and TDF/FTC PrEP naïve
6. Willing and able to provide written informed consent and adhere to the study requirements
7. Non-reactive / negative HIV test results, including both HIV rapid tests and an undetectable HIV RNA at enrollment for individuals choosing injectable CAB-LA.
8. No report of hepatic dysfunction. Candidates reporting liver disease will have their enrollment visit postponed until laboratory results of liver function are available. Individuals with ALT \>=5x ULN, OR ALT\>=3xULN and bilirubin \>=1.5xULN will be excluded. See section 7 (Study Procedures - Enrollment visit).
9. Willing to undergo all required study procedures.

Exclusion Criteria:

1. One or more reactive or positive HIV test result at enrollment visit, even if HIV infection is not confirmed.
2. Currently participating in interventional trial of PrEP agents, HIV vaccine trial or experimental medication.
3. Positive pregnancy test, breastfeeding, or intention to become pregnant at enrolment (for transgender men).
4. Prior participation in studies with Cabotegravir.
5. A history or presence of allergy to the study drug components.
6. Past participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm).
7. Plan to relocate out of the area during the study period.
8. Surgically placed or injected buttock implants or fillers, per self-report.
9. Has a dermatological/inflammatory skin condition overlying the buttock region which in the opinion of the study investigator, in consultation with the Clinical Study Coordination (CSC), may interfere with interpretation of injection site reactions.
10. Active or planned use of contraindicated co-administered for which significant decreases in Cabotegravir plasma concentrations may occur due uridine diphosphate glucuronosyltransferase (UGT1A1):

    * Anticonvulsants: Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin
    * Antimycobacterials: Rifampin, Rifapentine \*Any prohibited medications that decrease CAB concentrations should be discontinued for a minimum of four weeks or a minimum of three half-lives (whichever is longer) prior to the first dose.
11. Current or anticipated need for chronic systemic anticoagulation or a history of known or suspected bleeding disorder, including a history of prolonged bleeding.
12. History of severe hepatic impairment (including but not limited to a history of liver failure or hospitalization for liver disease, a history of hepatocellular carcinoma or near liver transplant).
13. Individuals with advanced Hepatitis C.
14. Other medical conditions that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical).

Where this trial is running

Rio de Janeiro

• Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ — Rio de Janeiro, Brazil (Recruiting)

Study contacts

• Principal investigator: Beatriz Grinsztejn, MD, PhD — Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ
• Study coordinator: Thiago Torres, Pharm D, PhD

Conditions HIV Infections; Cabotegravir; pre exposure prophylaxis