The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Evandro Chagas National Institute of Infectious Disease
• Collaborators: Beatriz Grinsztejn; Brenda Hoagland; Thiago Torres; Valdilea Gonçalves
• Treatments: Cabotegravir

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).