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

April 17, 2026 updated by: Babafemi Taiwo, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized stepped wedge (cluster) trial will be conducted to investigate a combination interventions (with mHealth + Peer Navigation components) among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. The Treatment Intervention will test a combination intervention that targets HIV treatment outcomes (retention, adherence and viral suppression).

Study Type

Interventional

Enrollment (Actual)

541

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Ibadan, Nigeria
        • University of Ibadan
      • Jos, Nigeria
        • Jos University Teaching Hospital
      • Lagos, Nigeria
        • Lagos University Teaching Hospital
      • Lagos, Nigeria
        • Lagos State University Teaching Hospital
      • Lagos, Nigeria
        • Nigerian Institute of Medical Research (NIMR)
      • Sagamu, Nigeria
        • Olabisi Onabanjo University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence A (Cluster 1): HIV Treatment Intervention
0 to 48 weeks intervention, 49-72 weeks post-intervention
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
Other: Sequence B (Cluster 2): HIV Treatment Intervention
0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention
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
Other: Sequence C (Cluster 3): HIV Treatment Intervention
0 to 48 weeks pre-intervention, 49 - 96 weeks intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Viral Load Suppression, (Plasma HIV-1 RNA <200 Copies/ml)
Time Frame: Clusters randomized to 1 of 3 sequences, which determined timing of the intervention: Sequence 1 (intervention at visit 1=0 weeks(at baseline), 2 (intervention at visit 2: 24 weeks post baseline) or 3 (intervention at visit 3: 48 weeks post baseline)
We assessed the change in proportion of participants who were virally suppressed before and after exposure to 48 weeks of the iCARE intervention.
Clusters randomized to 1 of 3 sequences, which determined timing of the intervention: Sequence 1 (intervention at visit 1=0 weeks(at baseline), 2 (intervention at visit 2: 24 weeks post baseline) or 3 (intervention at visit 3: 48 weeks post baseline)
Proportion With Virologic Suppression (HIV-1 RNA<200 Copies mL)
Time Frame: 24 Week Period
Proportion of participants with viral load suppression, defined as viral load (plasma HIV-1 RNA <200 copies/ml); 24 Week Period
24 Week Period
Proportion With Viral Load Suppression (HIV RNA <200 Copies/ml)
Time Frame: 48 Week Period
Proportion of participants with viral load suppression, defined as viral load (plasma HIV-1 RNA <200 copies/ml); 48 Week Period
48 Week Period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Antiretrovial Adherence
Time Frame: Clusters randomized to 1 of 3 sequences, which determined timing of the intervention: Sequences 1 (intervention at visit 1=0 weeks (at baseline), 2 (intervention at visit 2: 24 weeks post baseline) or 3 (intervention at visit 3: 48 weeks post baseline)
Number and proportion of participants with self-reported antiretroviral adherence based on 30-day recall reported on visual analogue scale, defined as >=90%
Clusters randomized to 1 of 3 sequences, which determined timing of the intervention: Sequences 1 (intervention at visit 1=0 weeks (at baseline), 2 (intervention at visit 2: 24 weeks post baseline) or 3 (intervention at visit 3: 48 weeks post baseline)
Proportion of Participants With Antiretroviral Adherence
Time Frame: 24 Week period
Number and proportion of participants with self-reported antiretroviral adherence based no 30-day recall reported on visual analogue scale, defined as >=90%
24 Week period
Proportion of Participants With Antiretroviral Adherence >=90%
Time Frame: 48 Week Period
Number and proportion of participants with self-reported antiretroviral adherence based no 30-day recall reported on visual analogue scale, defined as >=90%
48 Week Period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV testing and seroprevalence among young men across multiple sites
Time Frame: 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).
Week 48
Linkage of newly diagnosed young men to a clinic for ART
Time Frame: 48 weeks
Percentage of young men who are linked to HIV care within 30 days of an HIV confirmatory test
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

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

Investigators

  • Principal Investigator: Babafemi Taiwo, MBBS, Northwestern University
  • Principal Investigator: Robert Garofalo, MD, Ann & Robert Lurie Childrens Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

July 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iCARE Nigeria UH3
  • UH3HD096920 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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