Actively Recruiting

Phase Not Applicable
Age: 15Years - 24Years
All Genders
Healthy Volunteers
NCT06880224

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

Led by Northwestern University · Updated on 2026-04-08

500

Participants Needed

6

Research Sites

186 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

E

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 15Years - 24Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 15 to 24 years
  • Male birth sex of any current gender identity (for HIV Case Finding Intervention)
  • Understand basic English, Yoruba, Hausa, Igbo, or Pidgin English
  • For PrEP component, must be HIV-negative
  • HIV seropositive (for HIV Treatment Intervention)
  • Initiating ART for the first time at a Clinical Research Performance Site (CRPS) clinic or satellite clinic
  • Intention to remain a CRPS patient during follow-up
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 6 locations

1

University of Uyo Teaching Hospital

Uyo, Akwa Ibom State, Nigeria

Actively Recruiting

2

Federal Medical Center

Makurdi, Benue State, Nigeria

Actively Recruiting

3

Taraba State Specialist Hospital

Jalingo, Taraba State, Nigeria

Actively Recruiting

4

University of Nigeria Teaching Hospital

Enugu, Nigeria

Actively Recruiting

5

Aminu Kano Teaching Hospital

Kano, Nigeria

Actively Recruiting

6

Lagos University Teaching Hospital

Lagos, Nigeria

Actively Recruiting

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Research Team

R

Robert Garofalo, MD

CONTACT

L

Lisa M Kuhns, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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