ClinicalTrials.gg
RecruitingNCT06880224iCARE PlusUpdated Apr 8, 2026

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

An interventional study of Testing Peer navigation and PrEP Intervention in Adolescent HIV Infection, sponsored by Northwestern University. Recruiting at 6 sites in Nigeria. Open to participants aged 15 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Northwestern University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
15 Years to 24 Years
Sex
All
01

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.

Read the 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
02

Conditions studied

  • Adolescent HIV Infection

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Keywords

  • Adolescents, HIV Testing, HIV Treatment
03

In context

HIV Infections

4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.

This study's planned enrollment of 500 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.

Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion Criteria:

  • Unable to provide consent
  • No parental permission if aged 15 and not emancipated
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    HIV Case Finding Intervention

    Combination HIV case finding and linkage to care intervention

    Behavioral: Testing Peer navigation · Behavioral: PrEP Intervention · Behavioral: Social Media Outreach

  • 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 · Behavioral: SMS Test messaging · Other: Adherence standard of care

Interventions

  • BehavioralTesting Peer navigation

    Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive

  • BehavioralPrEP Intervention

    Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative

  • BehavioralTreatment Peer Navigation

    Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART

  • BehavioralSocial Media Outreach

    Social media outreach to identify youth at risk for HIV

  • BehavioralSMS Test messaging

    Text (SMS) messages to remind and encourage youth to adhere to their ART

  • OtherAdherence standard of care

    Standard of care HIV treatment adherence

06

What researchers measure

Primary outcomes

  1. Case Finding: HIV-positive serostatus

    HIV-positive serostatus based on rapid test with confirmation

    Time frame: 48 weeks

  2. Treatment: Viral suppression

    Viral suppression (\< 200 copies per mL)

    Time frame: 48 Weeks

Secondary outcomes

  1. Case Finding: Linkage to HIV care

    Linkage to HIV care within 30 days of positive HIV test

    Time frame: 48 Weeks

  2. Case Finding: PrEP among youth who test HIV-negative

    PrEP uptake among youth who test HIV-negative

    Time frame: 48 weeks

  3. Treatment: Adherence to antiretroviral therapy (ART)

    \> 90% adherence to ART

    Time frame: 48 Weeks

07

Study locations

6 of 6 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Aug 2028, 42 months after the start.

Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 42 months is above that.

Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2025
First posted
Mar 17, 2025
StartActual
Feb 1, 2025
Primary completionEst.
Aug 31, 2028
CompletionEst.
Aug 31, 2028
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06880224
Responsible party
Robert Garofalo (Professor, Northwestern University) — Principal investigator
First posted
Mar 17, 2025
Start date
Feb 1, 2025
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Apr 8, 2026

Study contacts

Robert Garofalo, MD
Contact
rgarofalo@luriechildrens.org
312-227-7740
Lisa M Kuhns, PhD
Contact
lkuhns@luriechildrens.org
312-227-7740
Robert Garofalo, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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