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

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

Recruiting
15-24 years
All
Phase N/A

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Overview

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.

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

Eligibility

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 details
    Adolescent HIV Infection

NCT06880224

Northwestern University

15 October 2025

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