The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir (NCT05515770) | Clinical Trial Compass
RecruitingPhase 3
The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir
Brazil1,200 participantsStarted 2022-09-20
Plain-language 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.
Who can participate
Age range18 Years – 30 Years
SexMALE
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Inclusion criteria
✓. Cisgender men, non-binary (assigned as male at birth) or transgender women and men
✓. 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)
✓. Age 18-30 years
✓. Seek a study clinic looking for PrEP
✓. CAB LA and TDF/FTC PrEP naïve
✓. Willing and able to provide written informed consent and adhere to the study requirements
✓. Non-reactive / negative HIV test results, including both HIV rapid tests and an undetectable HIV RNA at enrollment for individuals choosing injectable CAB-LA.
✓. No report of hepatic dysfunction. Candidates reporting liver disease will have their enrollment visit postponed until laboratory results of liver function are available. Individuals with ALT \>=5x ULN, OR ALT\>=3xULN and bilirubin \>=1.5xULN will be excluded. See section 7 (Study Procedures - Enrollment visit).
Exclusion criteria
What they're measuring
1
Incident HIV infection
Timeframe: 2 years
Trial details
NCT IDNCT05515770
SponsorEvandro Chagas National Institute of Infectious Disease
✕. One or more reactive or positive HIV test result at enrollment visit, even if HIV infection is not confirmed.
✕. Currently participating in interventional trial of PrEP agents, HIV vaccine trial or experimental medication.
✕. Positive pregnancy test, breastfeeding, or intention to become pregnant at enrolment (for transgender men).
✕. Prior participation in studies with Cabotegravir.
✕. A history or presence of allergy to the study drug components.
✕. Past participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm).
✕. Plan to relocate out of the area during the study period.
✕. Surgically placed or injected buttock implants or fillers, per self-report.