Menu
Recruiting NCT06880224

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

No phase Interventional Adolescent HIV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Testing Peer navigation, PrEP Intervention, Treatment Peer Navigation, Social Media Outreach.
Who it may be relevant to
Registry conditions: Adolescent HIV Infection. Basic parameters: 15 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Nigeria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study: Aim 2

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.

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

Interventions

  • Behavioral Testing Peer navigation
    Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive
  • Behavioral PrEP Intervention
    Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative
  • Behavioral Treatment Peer Navigation
    Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART
  • Behavioral Social Media Outreach
    Social media outreach to identify youth at risk for HIV
  • Behavioral SMS Test messaging
    Text (SMS) messages to remind and encourage youth to adhere to their ART
  • Other Adherence standard of care
    Standard of care HIV treatment adherence

Primary outcome measures

  • Case Finding: HIV-positive serostatus [Time frame: 48 weeks]
  • Treatment: Viral suppression [Time frame: 48 Weeks]
Secondary outcome measures (3)
  • Case Finding: Linkage to HIV care [Time frame: 48 Weeks]
  • Case Finding: PrEP among youth who test HIV-negative [Time frame: 48 weeks]
  • Treatment: Adherence to antiretroviral therapy (ART) [Time frame: 48 Weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Nigeria · 6 centers
  • University of Uyo Teaching Hospital — Uyo
  • Federal Medical Center — Makurdi
  • Taraba State Specialist Hospital — Jalingo
  • University of Nigeria Teaching Hospital — Enugu
  • Aminu Kano Teaching Hospital — Kano
  • Lagos University Teaching Hospital — Lagos

Identifiers

NCT: NCT06880224 · iCARE Plus · UG1HD113160

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗