Clinical trial NCT06880224: Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study
Official title: Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study: Aim 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent HIV Infection
Keywords: Adolescents, HIV Testing, HIV Treatment
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-03-17
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a hybrid effectiveness/implementation trial with an HIV Case Finding Intervention "Arm" and a parallel HIV Treatment Intervention "Arm" that is a randomized controlled trial.
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: Case Finding: HIV-positive serostatus
timeFrame: 48 weeks
measure: Treatment: Viral suppression
timeFrame: 48 Weeks
Secondary outcomes:
measure: Case Finding: Linkage to HIV care
timeFrame: 48 Weeks
measure: Case Finding: PrEP among youth who test HIV-negative
timeFrame: 48 weeks
measure: Treatment: Adherence to antiretroviral therapy (ART)
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Uyo
country: Nigeria
facility: University of Uyo Teaching Hospital
state: Akwa Ibom
city: Makurdi
country: Nigeria
facility: Federal Medical Center
state: Benue
city: Jalingo
country: Nigeria
facility: Taraba State Specialist Hospital
state: Taraba
city: Enugu
country: Nigeria
facility: University of Nigeria Teaching Hospital
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
Study officials:
affiliation: Northwestern University
name: Robert Garofalo, MD
role: PRINCIPAL_INVESTIGATOR
References: