The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir

NCT05515770 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 59166522.7.1001.5262
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

Cabotegravir; pre exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

• Incident HIV infection

  Among individuals who test positive on HIV rapid test, midpoint between last negative HIV rapid test and first HIV positive rapid test

  2 years

Study Arms (1)

Injectable Cabitegravir

EXPERIMENTAL

Participants that are interested in Cab long action injectable

Drug: Cabotegravir Injection

Interventions

Cabotegravir Injection DRUG

Long action cabotegravir injection

Also known as: brand name: Apretude

Injectable Cabitegravir

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Cisgender men, non-binary (assigned as male at birth) or transgender women and men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cisgender men, non-binary (assigned as male at birth) or transgender women and men
• 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)
• Age 18-30 years
• Seek a study clinic looking for PrEP
• CAB LA and TDF/FTC PrEP naïve
• Willing and able to provide written informed consent and adhere to the study requirements
• Non-reactive / negative HIV test results, including both HIV rapid tests and an undetectable HIV RNA at enrollment for individuals choosing injectable CAB-LA.
• 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).
• Willing to undergo all required study procedures.

You may not qualify if:

• One or more reactive or positive HIV test result at enrollment visit, even if HIV infection is not confirmed.
• Currently participating in interventional trial of PrEP agents, HIV vaccine trial or experimental medication.
• Positive pregnancy test, breastfeeding, or intention to become pregnant at enrolment (for transgender men).
• Prior participation in studies with Cabotegravir.
• A history or presence of allergy to the study drug components.
• Past participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm).
• Plan to relocate out of the area during the study period.
• Surgically placed or injected buttock implants or fillers, per self-report.
• 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.
• 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.
• Current or anticipated need for chronic systemic anticoagulation or a history of known or suspected bleeding disorder, including a history of prolonged bleeding.
• 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).
• Individuals with advanced Hepatitis C.

Sponsors & Collaborators

• Evandro Chagas National Institute of Infectious Disease: lead
• Beatriz Grinsztejn: collaborator
• Thiago Torres: collaborator
• Valdilea Gonçalves: collaborator
• Brenda Hoagland: collaborator

Study Sites (1)

Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ

Rio de Janeiro, 21040-360, Brazil

RECRUITING

Related Publications (2)

• Pimenta C, Mann CG, Hoagland B, Carvalheira E, Jalil C, Benedetti M, Fernandes N, Coutinho C, Jalil EM, Secco Torres Silva M, Trefiglio R, Farias A, Mourao MPG, Madruga JV, de Lima JN, Zonta R, O'Malley G, Veloso VG, Grinsztejn B, Torres TS; ImPrEP CAB-Brasil Study. Exploring perceptions and preferences for PrEP choice and of an mHealth intervention: insights from the ImPrEP CAB-Brasil study. J Int AIDS Soc. 2025 Jul;28 Suppl 2(Suppl 2):e26493. doi: 10.1002/jia2.26493.

  PMID: 40600468 DERIVED

• Grinsztejn B, Torres TS, Hoagland B, Jalil EM, Moreira RI, O'Malley G, Shade SB, Benedetti MR, Moreira J, Simpson K, Pimenta MC, Veloso VG; ImPrEP CAB-Brasil Study Team. Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study. JMIR Public Health Surveill. 2023 Apr 19;9:e44961. doi: 10.2196/44961.

  PMID: 37074775 DERIVED

Related Links

• WHO. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Second Edition. Recommendations for a public health approach
• UNAIDS. New HIV infections rising in Latin America-key populations particularly affected \[Internet\]. 2019 \[cited 2022 Apr 21\].
• UNAIDS. Global Aids Strategy 2021 - 2026 End Inequalities . End Aids . Unaids \[Internet\]. 2021;160
• United Nations Programme on HIV/aids. UNAIDS. UNAIDS data 2021. 2021;4-38.

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Beatriz Grinsztejn, MD, PhD

  Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ

  PRINCIPAL INVESTIGATOR

• Valdilea Veloso, MD, PhD

  Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ

  STUDY DIRECTOR

Central Study Contacts

Thiago Torres, Pharm D, PhD

CONTACT

+55213865-9573; thiago.torres@ini.fiocruz.br

Brenda Hoagland, MD, PhD

CONTACT

+55213865-9122; brenda.hoagland@ini.fiocruz.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beatriz Grinsztejn, MD, PhD

Model Details: We will use both quantitative (surveys, laboratory tests, service statistics) and qualitative (in-depth interviews and focus group discussions) methods. HIV incidence in the CAB LA cohort (N=1200) in this study will be compared with a similar cohort accessing oral PrEP through the public health system. The effectiveness of the mHealth intervention will be assessed using interrupted time series analysis. The WhatsApp intervention will be randomized at the individual level and data analyzed using logistic mixed models.

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: September 20, 2022
• Primary Completion: October 1, 2025
• Study Completion: February 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

BR (1)