A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories (EBONI)

ViiV Healthcare

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: APRETUDE; Drug: Cabotegravir tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05514509

217711

Details and patient eligibility

About

The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.

Enrollment: 162 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant must be ≥18 years of age, at the time of signing the informed consent.
• HIV negative at screening. Type of HIV-1 test is per standard of care.
• No prior history of receiving oral CAB or CAB LA injections.
• PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study.
• Female at birth or self-identified Transgender Female.
• Self-identified as African American/Black
• Capable of giving signed informed consent

Exclusion criteria

• HIV indeterminate or positive test result during screening.
• A participant of concurrent interventional clinical or implementation science study at any time during the study.
• Cis-gender or Transgender male

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 3 patient groups

Standard Implementation (SI)

Active Comparator group

Description:

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.

Treatment:

Drug: Cabotegravir tablet

Drug: APRETUDE

Enhanced Implementation (EI)

Experimental group

Description:

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.

Treatment:

Drug: Cabotegravir tablet

Drug: APRETUDE

Enhanced Collaborative Implementation (ECI)

Experimental group

Description:

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.

Treatment:

Drug: Cabotegravir tablet

Drug: APRETUDE