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

NCT04950153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2026-04-21

Study results available
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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 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.

Conditions

  • Adolescent HIV Infection

Interventions

BEHAVIORAL

Peer navigation

Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)

BEHAVIORAL

SMS Text messaging

Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Northwestern University

    lead OTHER

Principal Investigators

  • Babafemi Taiwo, MBBS · Northwestern University

  • Robert Garofalo, MD · Ann & Robert Lurie Childrens Hospital of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2024-08-30
Completion
2024-12-31

Countries

  • Nigeria

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04950153 on ClinicalTrials.gov