Adolescent HIV Infection
Conditions
Brief summary
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
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).
Interventions
BEHAVIORALPeer navigation
Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)
BEHAVIORALSMS Text messaging
Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART
BEHAVIORALSocial Media Engagement
HIV testing outreach using social media platforms to promote HIV testing.
BEHAVIORALTesting Peer Navigation
Peer navigators will conduct HIV testing outreach and linkage to care to at-risk youth
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
Stepped wedge (cluster) randomized trial
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VIral suppression | Week 48 | Proportion of participants with viral suppression, defined as viral load (plasma HIV-1 RNA) \<200 copies/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiretrovial adherence measured by pharmacy drug pick-up | Week 48 | Pharmacy drug pick-up (90% of days with medication) |
| Antiretroviral drug concentration | Week 48 | Antiretroviral drug concentration in Dried Blood Spot sufficient for viral suppression |
| Retention in care | Week 48 | Retention, defined as at least two care (non-study) visits in the prior 24-week period |
Other
| Measure | Time frame | Description |
|---|---|---|
| HIV testing and seroprevalence among young men across multiple sites | Week 48 | HIV seroprevalence among the tested young men during the intervention period (the number of confirmed HIV cases divided by the total number of tests). |
| Linkage of newly diagnosed young men to a clinic for ART | 48 weeks | Percentage of young men who are linked to HIV care within 30 days of an HIV confirmatory test |
Countries
Nigeria
Outcome results
None listed