Combining interventions to address HIV in Nigerian youth
Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study: Aim 2
NA · Northwestern University · NCT06880224
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 15 Years to 24 Years |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Locations | 6 sites (Uyo, Akwa Ibom State and 5 other locations) |
| Trial ID | NCT06880224 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include males aged 15-24 who are either at risk of HIV infection or newly diagnosed with HIV.
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.
Why it matters
Potential benefit: If successful, this study could significantly improve HIV detection and treatment outcomes among Nigerian youth.
How similar studies have performed: Other studies have shown success with similar combination intervention approaches in addressing HIV, indicating potential for positive outcomes in this study.
Eligibility criteria
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 this trial is running
Uyo, Akwa Ibom State and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adolescent HIV Infection, Adolescents, HIV Testing, HIV Treatment