Adolescent HIV Infection
Conditions
Keywords
Adolescents, HIV Testing, HIV Treatment
Brief 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.
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
BEHAVIORALTesting Peer navigation
Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive
BEHAVIORALPrEP Intervention
Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative
BEHAVIORALTreatment Peer Navigation
Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART
BEHAVIORALSocial Media Outreach
Social media outreach to identify youth at risk for HIV
BEHAVIORALSMS Test messaging
Text (SMS) messages to remind and encourage youth to adhere to their ART
OTHERAdherence standard of care
Standard of care HIV treatment adherence
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Case Finding: HIV-positive serostatus | 48 weeks | HIV-positive serostatus based on rapid test with confirmation |
| Treatment: Viral suppression | 48 Weeks | Viral suppression (\< 200 copies per mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Case Finding: Linkage to HIV care | 48 Weeks | Linkage to HIV care within 30 days of positive HIV test |
| Case Finding: PrEP among youth who test HIV-negative | 48 weeks | PrEP uptake among youth who test HIV-negative |
| Treatment: Adherence to antiretroviral therapy (ART) | 48 Weeks | \> 90% adherence to ART |
Countries
Nigeria
Contacts
Primary ContactRobert Garofalo, MD
Backup ContactLisa M Kuhns, PhD
Outcome results
None listed