NCT06880224

Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study

Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study: Aim 2

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 15 Years – 24 Years
• Healthy volunteers: Accepted

Summary

Two combination interventions (HIV Case Finding Intervention and HIV Treatment Intervention), each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria.

Detailed description

Two combination interventions, each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria: 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

• Adolescent HIV Infection

Interventions

Type	Name	Description
BEHAVIORAL	Testing Peer navigation	Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive
BEHAVIORAL	PrEP Intervention	Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative
BEHAVIORAL	Treatment Peer Navigation	Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART
BEHAVIORAL	Social Media Outreach	Social media outreach to identify youth at risk for HIV
BEHAVIORAL	SMS Test messaging	Text (SMS) messages to remind and encourage youth to adhere to their ART
OTHER	Adherence standard of care	Standard of care HIV treatment adherence

Timeline

• Start date: 2025-02-01
• Primary completion: 2028-08-31
• Completion: 2028-08-31
• First posted: 2025-03-17
• Last updated: 2026-04-08

Locations

6 sites across 1 country: Nigeria