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

Not Applicable

Recruiting

• Conditions: Adolescent HIV Infection

• Registration Number: NCT06880224
• Lead Sponsor: Northwestern University

Brief 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.

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 Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-01
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Case Finding: HIV-positive serostatus	48 weeks	HIV-positive serostatus based on rapid test with confirmation
Treatment: Viral suppression	48 Weeks	Viral suppression (\< 200 copies per mL)

Secondary Outcome Measures

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

Trial Locations

Locations (6)

University of Uyo Teaching Hospital; 🇳🇬 Uyo, Akwa Ibom, Nigeria

Federal Medical Center; 🇳🇬 Makurdi, Benue, Nigeria

Taraba State Specialist Hospital; 🇳🇬 Jalingo, Taraba, Nigeria

University of Nigeria Teaching Hospital; 🇳🇬 Enugu, Nigeria

Aminu Kano Teaching Hospital; 🇳🇬 Kano, Nigeria

Lagos University Teaching Hospital; 🇳🇬 Lagos, Nigeria