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

Northwestern University

Status: Enrolling

Conditions: Adolescent HIV Infection

Treatments: Behavioral: Social Media Outreach; Behavioral: Treatment Peer Navigation; Behavioral: Testing Peer navigation; Behavioral: PrEP Intervention; Other: Adherence standard of care; Behavioral: SMS Test messaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06880224

iCARE Plus

UG1HD113160 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

HIV Case Finding Intervention

Experimental group

Description:

Combination HIV case finding and linkage to care intervention

Treatment:

Behavioral: PrEP Intervention

Behavioral: Testing Peer navigation

Behavioral: Social Media Outreach

HIV Treatment Intervention

Experimental group

Description:

Combination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART

Treatment:

Behavioral: SMS Test messaging

Other: Adherence standard of care

Behavioral: Treatment Peer Navigation