Clinical trial NCT04950153: Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase
Official title: Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adolescent HIV Infection
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-07-06
Enrollment: 558
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped wedge (cluster) randomized trial
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: VIral suppression
timeFrame: Week 48
Secondary outcomes:
measure: Antiretrovial adherence measured by pharmacy drug pick-up
timeFrame: Week 48
measure: Antiretroviral drug concentration
timeFrame: Week 48
measure: Retention in care
timeFrame: Week 48
Other outcomes:
measure: HIV testing and seroprevalence among young men across multiple sites
timeFrame: Week 48
measure: Linkage of newly diagnosed young men to a clinic for ART
timeFrame: 48 weeks
Locations:
city: Ibadan
country: Nigeria
facility: University of Ibadan
city: Jos
country: Nigeria
facility: Jos University Teaching Hospital
city: Lagos
country: Nigeria
facility: Lagos State University Teaching Hospital
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
city: Lagos
country: Nigeria
facility: Nigerian Institute of Medical Research (NIMR)
city: Sagamu
country: Nigeria
facility: Olabisi Onabanjo University Teaching Hospital
Study officials:
affiliation: Northwestern University
name: Babafemi Taiwo, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ann & Robert Lurie Childrens Hospital of Chicago
name: Robert Garofalo, MD
role: PRINCIPAL_INVESTIGATOR
References: