The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir

Recruiting Phase 3 Interventional Study
HIV Infections
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 30
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
1,200 (estimated)
Sponsor
Evandro Chagas National Institute of Infectious Disease · Other
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About This Trial
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…
Trial Locations
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Eligibility 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. See…
Contacts

Thiago Torres, Pharm D, PhD

+55213865-9573

thiago.torres@ini.fiocruz.br

CONTACT

Brenda Hoagland, MD, PhD

+55213865-9122

brenda.hoagland@ini.fiocruz.br

CONTACT