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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase

Conditions
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Adolescent HIV Infection

Intervention / Treatment
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* Behavioral: Peer navigation
* Behavioral: SMS Text messaging
* Behavioral: Social Media Engagement
* Behavioral: Testing Peer Navigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped wedge (cluster) randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HIV Testing Intervention<br>Combination HIV testing and linkage to care intervention includes social media engagement and peer navigation | Behavioral: Social Media Engagement<br>* HIV testing outreach using social media platforms to promote HIV testing.<br>Behavioral: Testing Peer Navigation<br>* Peer navigators will conduct HIV testing outreach and linkage to care to at-risk youth<br>|
| Other: HIV Treatment Intervention<br>Combination HIV treatment outcomes (retention, ART adherence and viral suppression) intervention includes SMS text messaging and peer navigation | Behavioral: Peer navigation<br>* Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)<br>Behavioral: SMS Text messaging<br>* Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VIral suppression | Proportion of participants with viral suppression, defined as viral load (plasma HIV-1 RNA) <200 copies/ml | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiretrovial adherence measured by pharmacy drug pick-up | Pharmacy drug pick-up (90% of days with medication) | Week 48 | 
| Antiretroviral drug concentration | Antiretroviral drug concentration in Dried Blood Spot sufficient for viral suppression | Week 48 | 
| Retention in care | Retention, defined as at least two care (non-study) visits in the prior 24-week period | Week 48 |