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

NCT06880224 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

  • Adolescent HIV Infection

Interventions

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Northwestern University

    lead OTHER

Principal Investigators

  • Robert Garofalo, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880224 on ClinicalTrials.gov