Combining interventions to address HIV in Nigerian youth
Official title: Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study: Aim 2
Run by Northwestern University · NCT06880224 · Data updated 2026-11-12
This study is testing two different ways to help young people in Nigeria, aged 15-24, get tested for HIV and stick to their treatment to manage the virus better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years to 24 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Locations | 6 sites (Uyo, Akwa Ibom State and 5 other locations) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | August 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT06880224 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include males aged 15-24 who are either at risk of HIV infection or newly diagnosed with HIV.
✕Probably not a fit
Patients who are not within the age range of 15-24 or who are not HIV-positive will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates two combination interventions aimed at addressing HIV among youth aged 15-24 in Nigeria. The first intervention focuses on HIV case finding and linkage to care, particularly targeting young men who have sex with men, while the second intervention is a randomized controlled trial assessing medication adherence and viral suppression among newly diagnosed HIV patients. Both interventions incorporate mobile health (mHealth) strategies and peer navigation to enhance effectiveness. The study will run for 48 weeks and aims to improve HIV testing, treatment initiation, and adherence.
Why it matters
Potential benefit: If successful, this study could significantly improve HIV detection and treatment outcomes among Nigerian youth.
How similar studies have gone: Other studies have shown success with similar combination intervention approaches in addressing HIV, indicating potential for positive outcomes in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Uyo Teaching Hospital
Uyo, Akwa Ibom State, Nigeria Recruiting -
Federal Medical Center
Makurdi, Benue State, Nigeria Recruiting -
Taraba State Specialist Hospital
Jalingo, Taraba State, Nigeria Recruiting -
University of Nigeria Teaching Hospital
Enugu, Nigeria Recruiting -
Aminu Kano Teaching Hospital
Kano, Nigeria Recruiting -
Lagos University Teaching Hospital
Lagos, Nigeria Recruiting
Study contacts
- Principal investigator: Robert Garofalo, MD — Northwestern University
- Study coordinator: Robert Garofalo, MD
- Email: rgarofalo@luriechildrens.org
- Phone: 312-227-7740
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.