Actively Recruiting
The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir
Led by Evandro Chagas National Institute of Infectious Disease · Updated on 2024-10-08
1200
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
E
Evandro Chagas National Institute of Infectious Disease
Lead Sponsor
B
Beatriz Grinsztejn
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cisgender men, non-binary individuals assigned male at birth, or transgender women and men
- Report anal sex with a person assigned male at birth in the last six months
- Age between 18 and 30 years
- Seeking PrEP at a study clinic
- Have not previously used CAB LA or TDF/FTC PrEP
- Willing and able to provide written informed consent and follow study requirements
- Negative HIV test results including rapid tests and undetectable HIV RNA at enrollment for those choosing CAB-LA
- No reported liver dysfunction; liver function tests must be acceptable
- Willing to undergo all required study procedures
You will not qualify if you...
- Positive or reactive HIV test at enrollment, even if infection is unconfirmed
- Currently participating in another PrEP or HIV vaccine trial or experimental drug study
- Positive pregnancy test, breastfeeding, or planning pregnancy at enrollment (for transgender men)
- Prior participation in cabotegravir studies
- Allergy to study drug components
- Previous HIV vaccine trial participation without placebo documentation
- Planning to relocate during the study period
- Presence of surgically placed or injected buttock implants or fillers
- Skin conditions over the buttock that may affect injection site reactions
- Use of medications that lower cabotegravir levels (certain anticonvulsants and antimycobacterials)
- Current or planned need for long-term blood thinners or history of bleeding disorders
- History of severe liver impairment or serious liver disease
- Advanced Hepatitis C infection
- Other medical conditions that could interfere with study participation as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ
Rio de Janeiro, Brazil, 21040-360
Actively Recruiting
Research Team
T
Thiago Torres, Pharm D, PhD
CONTACT
B
Brenda Hoagland, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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