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

April 6, 2026 updated by: Robert Garofalo, Northwestern University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Nigeria
      • Enugu, Nigeria
        • Recruiting
        • University of Nigeria Teaching Hospital
        • Contact:
      • Kano, Nigeria
        • Recruiting
        • Aminu Kano Teaching Hospital
        • Contact:
      • Lagos, Nigeria
        • Recruiting
        • Lagos University Teaching Hospital
        • Contact:
    • Akwa Ibom State
      • Uyo, Akwa Ibom State, Nigeria
    • Benue State
      • Makurdi, Benue State, Nigeria
        • Recruiting
        • Federal Medical Center
        • Contact:
    • Taraba State
      • Jalingo, Taraba State, Nigeria
        • Recruiting
        • Taraba State Specialist Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

HIV Case Finding Intervention:

  • 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:

  • Unable to provide consent
  • No parental permission if aged 15 and not emancipated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIV Case Finding Intervention
Combination HIV case finding and linkage to care intervention
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: Social Media Outreach
Social media outreach to identify youth at risk for HIV
Experimental: HIV Treatment Intervention
Combination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART
Behavioral: Treatment Peer Navigation
Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Case Finding: HIV-positive serostatus
Time Frame: 48 weeks
HIV-positive serostatus based on rapid test with confirmation
48 weeks
Treatment: Viral suppression
Time Frame: 48 Weeks
Viral suppression (< 200 copies per mL)
48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Case Finding: Linkage to HIV care
Time Frame: 48 Weeks
Linkage to HIV care within 30 days of positive HIV test
48 Weeks
Case Finding: PrEP among youth who test HIV-negative
Time Frame: 48 weeks
PrEP uptake among youth who test HIV-negative
48 weeks
Treatment: Adherence to antiretroviral therapy (ART)
Time Frame: 48 Weeks
> 90% adherence to ART
48 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

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

Investigators

  • Principal Investigator: Robert Garofalo, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iCARE Plus
  • UG1HD113160 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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