Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study
NCT ID: NCT06880224
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2025-02-01
2028-08-31
Brief Summary
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Detailed Description
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1. HIV Case Finding Intervention: single arm trial of an HIV case finding and linkage to care intervention targeting young men at risk of HIV infection (n = 6000), particularly young men who have sex with men (YMSM) in Akwa Ibom, Benue, Enugu, Kano, Taraba, and Lagos states who complete HIV testing.
Objectives: To determine the effectiveness of the intervention to:
* identify youth living with HIV, particularly YMSM and
* link those who test HIV-positive to HIV care
* pre-exposure prophylaxis (PrEP) initiation (uptake) among those who test HIV-negative.
2. HIV Treatment Intervention: randomized controlled trial of a medication adherence and viral suppression intervention among youth newly diagnosed with HIV and initiating antiretroviral therapy (ART) for the first time (n = 600) at the participating clinical sites.
Objectives: To determine the effectiveness of the intervention on
* viral suppression and
* adherence to ART
* success of implementation in the target populations
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HIV Case Finding Intervention
Combination HIV case finding and linkage to care intervention
Testing Peer navigation
Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive
PrEP Intervention
Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative
Social Media Outreach
Social media outreach to identify youth at risk for HIV
HIV Treatment Intervention
Combination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART
Treatment Peer Navigation
Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART
SMS Test messaging
Text (SMS) messages to remind and encourage youth to adhere to their ART
Adherence standard of care
Standard of care HIV treatment adherence
Interventions
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Testing Peer navigation
Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive
PrEP Intervention
Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative
Treatment Peer Navigation
Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART
Social Media Outreach
Social media outreach to identify youth at risk for HIV
SMS Test messaging
Text (SMS) messages to remind and encourage youth to adhere to their ART
Adherence standard of care
Standard of care HIV treatment adherence
Eligibility Criteria
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Inclusion Criteria
* Aged 15 to 24
* Male birth sex of any current gender identity
* Understand basic English, Yoruba, Hausa, Igbo or Pidgin English For the PrEP component, must also be HIV-negative
HIV Treatment Intervention:
* Aged 15 to 24
* HIV seropositive
* Initiating ART for the first time at a Clinical Research Performance Site (CRPS) clinic or satellite clinic
* Understand basic English, Yoruba, Hausa, Igbo or Pidgin English
* Intention to remain a CRPS patient during follow-up
Exclusion Criteria
* No parental permission if aged 15 and not emancipated
15 Years
24 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Northwestern University
OTHER
Responsible Party
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Robert Garofalo
Professor
Principal Investigators
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Robert Garofalo, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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University of Uyo Teaching Hospital
Uyo, Akwa Ibom State, Nigeria
Federal Medical Center
Makurdi, Benue State, Nigeria
University of Nigeria Teaching Hospital
Enugu, Enugu State, Nigeria
Aminu Kano Teaching Hospital
Kano, Kano State, Nigeria
Lagos University Teaching Hospital
Lagos, Lagos, Nigeria
Taraba State Specialist Hospital
Jalingo, Taraba State, Nigeria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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iCARE Plus
Identifier Type: -
Identifier Source: org_study_id
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