💬In plain words
What the trial is, and whether it could suit you
Several studies show that Adolescents and Young Adults (AYA) have poor outcomes along the entire Human Immunodeficiency Virus (HIV) prevention and care cascades compared to adults. The investigators propose to evaluate novel evidence-based HIV prevention and care interventions (including Cabotegravir LongActing (CABLA) to determine implementation outcomes among AYA who are at particularly high risk for HIV acquisition and poor viral suppression in five geographically distinct research performance sites in Uganda. The results will provide important evidence to inform Uganda and other regional countries' policy on integrated HIV prevention, care and treatment for AYA at high risk for HIV and Sexually Transmitted Infections (STIs) in order to reach the UNAIDS 95-95-95 targets and HIV epidemic control.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Adolescents and young adults with increased likelihood of HIV acquisition
* AYA 15 to 24 years of age
* Classified as high risk using our screening tool.
* Documented HIV un-infected as per the national HIV testing algorithm.
* Willing to use PrEP
* Willing to provide written informed consent.
* No plans to relocate permanently in the next 6 months
* No suspicion of acute HIV infection:
* Hepatitis B virus surface antigen (HBsAg)-negative and accepts HB vaccination
* Having no medical or social condition that, in the opinion of the study investigator, would interfere with the conduct of the study or interpretation of study results.
* HIV-uninfected, based on HIV test results obtained at screening and enrolment visit and just prior to randomization. All HIV test results must be obtained and must all be negative/non-reactive according to national HIV testing algorithm. Adolescents and young adults living with HIV
* AYA 15-24 years' old
* Willing to receive ART at participating health facilities
* Have high-risk characteristics for viral load non-suppression, such as missed visits, disengagement from care, new to care, and non-suppressed viral load (VL) on the last VL testing.
* Willing to provide written informed consent.
* No plans to relocate permanently in the next 6 months
* Having no medical or social condition that, in the opinion of the study investigator, would interfere with the conduct of the study or interpretation of study results
Exclusion Criteria:
Adolescents and young adults with increased likelihood of HIV acquisition
* One or more reactive HIV test results at Screening or Enrollment, even if HIV infection is not confirmed.
* Has a cognitive impairment that prevents understanding of study procedures and precludes informed consent.
* Plan to move out of the greater study catchment area during study period.
* Enrolled in another intervention study.
* Already on PrEP.
* Unwilling or unable to commit to using CAB LA
* Ineligible to initiate CAB-LA as per the Uganda national PrEP guidelines
* Hepatotoxicity and or Hepatitis B infection
* Potential exposure to HIV in past 72 hours
* Signs/symptoms of acute HIV infection
* Current or chronic history of liver disease or known hepatic/biliary abnormalities, history of seizure disorder, clinically significant cardiovascular disease, coagulopathy, and inflammatory skin conditions, as defined in Human Subjects Protection document. (Cabotegravir IB or package insert)
* Hypersensitivity to any active substances or other substances in CAB-LA
* Allergic or hypersensitivity reaction(s) with previous use of CAB or other integrase inhibitor medications Adolescents and young adults living with HIV
* Not able to give written informed consent.
* Not receiving care in selected facilities
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