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

Last updated: March 11, 2025
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv Infections

Treatment

SMS Test messaging

Adherence standard of care

Treatment Peer Navigation

Clinical Study ID

NCT06880224
iCARE Plus
UG1HD113160
  • Ages 15-24
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 PrEPcomponent, 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

Exclusion Criteria:

  • Unable to provide consent

  • No parental permission if aged 15 and not emancipated

Study Design

Total Participants: 500
Treatment Group(s): 6
Primary Treatment: SMS Test messaging
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
August 31, 2028

Study 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

Connect with a study center

  • University of Uyo Teaching Hospital

    Uyo, Akwa Ibom
    Nigeria

    Active - Recruiting

  • Federal Medical Center

    Makurdi, Benue
    Nigeria

    Active - Recruiting

  • Taraba State Specialist Hospital

    Jalingo, Taraba
    Nigeria

    Active - Recruiting

  • University of Nigeria Teaching Hospital

    Enugu,
    Nigeria

    Active - Recruiting

  • Aminu Kano Teaching Hospital

    Kano,
    Nigeria

    Active - Recruiting

  • Lagos University Teaching Hospital

    Lagos,
    Nigeria

    Active - Recruiting

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