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The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir

NCT05515770 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2024-10-08

No results posted yet for this study

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

Interventions

DRUG

Cabotegravir Injection

Long action cabotegravir injection

Sponsors & Collaborators

  • Beatriz Grinsztejn

    collaborator UNKNOWN

  • Thiago Torres

    collaborator UNKNOWN

  • Valdilea Gonçalves

    collaborator UNKNOWN

  • Brenda Hoagland

    collaborator UNKNOWN

  • Evandro Chagas National Institute of Infectious Disease

    lead OTHER

Principal Investigators

  • Beatriz Grinsztejn, MD, PhD · Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ

  • Valdilea Veloso, MD, PhD · Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2025-10-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05515770 on ClinicalTrials.gov