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

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:

• 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.
• 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

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