Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase (iCARE)

Northwestern University

Status: Active, not recruiting

Conditions: Adolescent HIV Infection

Treatments: Behavioral: Peer navigation; Behavioral: Testing Peer Navigation; Behavioral: SMS Text messaging; Behavioral: Social Media Engagement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04950153

iCARE Nigeria UH3

UH3HD096920 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Combination interventions with mHealth and Peer Navigation components will be evaluated in a randomized, stepped wedge trial among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study findings will demonstrate whether or not the combination interventions for HIV testing and linkage to care and for HIV treatment outcomes, which were found to be efficacious in our prior pilot UG3 trial, will remain efficacious if scaled as proposed in this UH3 trial, across multiple sites.

Full description

A randomized stepped wedge (cluster) trial will be conducted to investigate two combination interventions (each with mHealth + Peer Navigation components) among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study 1 (Testing and Linkage to Care) will test a combination intervention that targets HIV testing and linkage to care. Study 2 (Treatment Intervention) will test a combination intervention that targets HIV treatment outcomes (retention, adherence and viral suppression).

Enrollment: 558 patients

Sex: All

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Living with HIV infection
• Registered in the study clinics or their satellite clinics
• On antiretroviral therapy (ART) for at least 3 months
• Intention to remain a study clinic patient during the study observation and intervention period

Exclusion criteria

• Inability to provide informed consent
• Youths who are 15 years old and not emancipated, who do not have parental consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

HIV Testing Intervention

Other group

Description:

Combination HIV testing and linkage to care intervention includes social media engagement and peer navigation

Treatment:

Behavioral: Social Media Engagement

Behavioral: Testing Peer Navigation

HIV Treatment Intervention

Other group

Description:

Combination HIV treatment outcomes (retention, ART adherence and viral suppression) intervention includes SMS text messaging and peer navigation

Treatment:

Behavioral: SMS Text messaging

Behavioral: Peer navigation