Health TrialsbyHealthPanel

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

ConditionAdolescent HIV Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
SponsorNorthwestern University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Aged 15 to 24

Disqualifiers

Unable to provide consent

No parental permission if aged 15 and not emancipated

Trial design

Design model

Parallel

Treatments tested in this trial

  • Testing Peer navigation

    Behavioral

    Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive

  • PrEP Intervention

    Behavioral

    Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative

  • Treatment Peer Navigation

    Behavioral

    Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART

  • Social Media Outreach

    Behavioral

    Social media outreach to identify youth at risk for HIV

  • SMS Test messaging

    Behavioral

    Text (SMS) messages to remind and encourage youth to adhere to their ART

  • Adherence standard of care

    Other intervention

    Standard of care HIV treatment adherence

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: HIV Case Finding InterventionExperimental treatment 3 interventions
Group B: HIV Treatment InterventionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Case Finding: HIV-positive serostatus

HIV-positive serostatus based on rapid test with confirmation

Time frame
48 weeks
2

Treatment: Viral suppression

Viral suppression (\< 200 copies per mL)

Time frame
48 Weeks

Secondary outcomes

1

Case Finding: Linkage to HIV care

Linkage to HIV care within 30 days of positive HIV test

Time frame
48 Weeks
2

Case Finding: PrEP among youth who test HIV-negative

PrEP uptake among youth who test HIV-negative

Time frame
48 weeks
3

Treatment: Adherence to antiretroviral therapy (ART)

\> 90% adherence to ART

Time frame
48 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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