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

September 22, 2023 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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

558

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HIV Testing Intervention
Combination HIV testing and linkage to care intervention includes social media engagement and peer navigation
Behavioral: Social Media Engagement
HIV testing outreach using social media platforms to promote HIV testing.
Behavioral: Testing Peer Navigation
Peer navigators will conduct HIV testing outreach and linkage to care to at-risk youth
Other: HIV Treatment Intervention
Combination HIV treatment outcomes (retention, ART adherence and viral suppression) intervention includes SMS text messaging and peer navigation
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
VIral suppression
Time Frame: Week 48
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
Time Frame: Week 48
Pharmacy drug pick-up (90% of days with medication)
Week 48
Antiretroviral drug concentration
Time Frame: Week 48
Antiretroviral drug concentration in Dried Blood Spot sufficient for viral suppression
Week 48
Retention in care
Time Frame: Week 48
Retention, defined as at least two care (non-study) visits in the prior 24-week period
Week 48

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

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, 2023

Study Completion (Estimated)

August 30, 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)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

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

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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