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.
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