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| ID | Type | Description | Link |
|---|---|---|---|
| UG1HD113160 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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:
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV Case Finding Intervention | Experimental | Combination HIV case finding and linkage to care intervention |
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| HIV Treatment Intervention | Experimental | Combination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing Peer navigation | Behavioral | Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive |
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| Measure | Description | Time Frame |
|---|---|---|
| Case Finding: HIV-positive serostatus | HIV-positive serostatus based on rapid test with confirmation | 48 weeks |
| Treatment: Viral suppression | Viral suppression (< 200 copies per mL) | 48 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Case Finding: Linkage to HIV care | Linkage to HIV care within 30 days of positive HIV test | 48 Weeks |
| Case Finding: PrEP among youth who test HIV-negative | PrEP uptake among youth who test HIV-negative |
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Inclusion Criteria:
HIV Case Finding Intervention:
HIV Treatment Intervention:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Garofalo, MD | Contact | 312-227-7740 | rgarofalo@luriechildrens.org | |
| Lisa M Kuhns, PhD | Contact | 312-227-7740 | lkuhns@luriechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Garofalo, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Uyo Teaching Hospital | Recruiting | Uyo | Akwa Ibom State | Nigeria |
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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.
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| PrEP Intervention | Behavioral | Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative |
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| Treatment Peer Navigation | Behavioral | Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART |
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| Social Media Outreach | Behavioral | Social media outreach to identify youth at risk for HIV |
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| SMS Test messaging | Behavioral | Text (SMS) messages to remind and encourage youth to adhere to their ART |
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| Adherence standard of care | Other | Standard of care HIV treatment adherence |
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| 48 weeks |
| Treatment: Adherence to antiretroviral therapy (ART) | > 90% adherence to ART | 48 Weeks |
| Federal Medical Center | Recruiting | Makurdi | Benue State | Nigeria |
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| Taraba State Specialist Hospital | Recruiting | Jalingo | Taraba State | Nigeria |
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| University of Nigeria Teaching Hospital | Recruiting | Enugu | Nigeria |
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| Aminu Kano Teaching Hospital | Recruiting | Kano | Nigeria |
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| Lagos University Teaching Hospital | Recruiting | Lagos | Nigeria |
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