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Antiretroviral Agent
APRETUDE for HIV Prevention (EBONI Trial)
Phase 4
Recruiting
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1, 4, 5, 12 and 13
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial studies how well a drug called Cabotegravir works to prevent HIV infection, and how easy it is to give to people in a clinical setting. It looks at two types of participants: those receiving the drug, and those administering it.
Who is the study for?
This trial is for Black cisgender and transgender women over 18 years old who are HIV negative, have never taken Cabotegravir (CAB) before, and can consent to the study. They must be considered appropriate candidates for CAB pre-exposure prophylaxis (PrEP) by their healthcare provider.
What is being tested?
The study tests how well strategies work for delivering APRETUDE (Cabotegravir tablet), a medication used to prevent HIV infection. It looks at how suitable, adoptable, feasible, faithful to plan, and acceptable these strategies are in real-world settings.
What are the potential side effects?
APRETUDE may cause side effects like allergic reactions, liver problems, depression or mood changes. Some people might experience pain or swelling where they got the injection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1, 4, 5, 12 and 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1, 4, 5, 12 and 13
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Intervention Appropriateness Measure (IAM) Score in SSPs
Secondary study objectives
Acceptability of Intervention Measure (AIM) Score for APRETUDE in SSPs and PSPs
Appropriateness of APRETUDE Assessed by SSP Questionnaire responses at Month 1, 4, 5, 12 and 13
Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13
+32 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Implementation (EI)Experimental Treatment2 Interventions
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The EI arm will receive all components of SI arm and additional provider-focused implementation strategies. Provider-focused strategies will include a patient-provider communication tool, Provider Education, and enhanced tool kit materials.
Group II: Enhanced Collaborative Implementation (ECI)Experimental Treatment2 Interventions
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The ECI arm will involve implementation strategies to support patient activation and provider awareness. Clinics randomized to ECI will receive all components of SI and additional implementation strategies to support patient activation and ensure provider awareness. ECI strategies will include a patient information and product resources and peer support.
Group III: Standard Implementation (SI)Active Control2 Interventions
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as oral lead in (OLI). The SI arm receives the standard toolkits that are anticipated to be available for APRETUDE that includes information resource for PSPs and SSPs.
Find a Location
Who is running the clinical trial?
ViiV HealthcareLead Sponsor
373 Previous Clinical Trials
470,162 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,604 Previous Clinical Trials
6,144,468 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a female by birth or identify as a transgender female.I am 18 years old or older.I have never received CAB treatments.I identify as a cisgender or transgender male.I have never taken oral CAB or received CAB LA injections.My doctor agrees that CAB PrEP is suitable for me according to its prescription guidelines.I am able to understand and sign the consent form.I am a female by birth or identify as a transgender female.I am 18 years old or older.You have identified yourself as a person of African American or Black ethnicity.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Collaborative Implementation (ECI)
- Group 2: Standard Implementation (SI)
- Group 3: Enhanced Implementation (EI)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Human Immunodeficiency Virus Infection Patient Testimony for trial: Trial Name: NCT05514509 — Phase 4
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