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Taking people in UgandaPhase 4

Testing HIV prevention and care approaches for young people in Uganda

Tests long-acting cabotegravir injections and support services in young people at high HIV risk.

Plain-language title generated from the registry record
Registry title: HIV Prevention and Care Interventions for Youth in Uganda

Key facts

Where
Kampala, UgandaSee the site
Phase
Phase 4

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 15 and 24 years old?

Source: NCT06474364, who can take part

Where in Uganda

  • MU-JHU Care LtdKampala, UgandaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
MU-JHU CARE
Trial code
NCT06474364
Record updated
29 July 2025
Original description
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.Read full original descriptionShow less

Using Implementation Science to Understand and Design Stakeholder Informed Innovative Interventions to Improve Youth HIV Prevention and Care Continuums in Rural and Urban Uganda.

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.

Exclusion: Allergic or hypersensitivity reaction(s) with previous use of CAB or other integrase inhibitor medications Adolescents and young adults living with HIV; Not receiving care in selected facilities; 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; 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; 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; Not able to give written informed consent.

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.

ClinicalTrials.gov NCT06474364