BridgeMD
Prevention study for HIV
Official title HIV Prevention and Care Interventions for Youth in Uganda
ClinicalTrials.gov ID: NCT06474364
What this study is testing
What is Long-acting Cabotegravir injection?
Long-acting Cabotegravir injection is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 24. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kampala, Uganda
Compensation & support
Some study costs may be covered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 24 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kampala, Uganda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.