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

Primary Purpose

Adolescent HIV Infection

Status
Active
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Peer navigation
SMS Text messaging
Social Media Engagement
Testing Peer Navigation
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent HIV Infection

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

HIV Testing Intervention

HIV Treatment Intervention

Arm Description

Combination HIV testing and linkage to care intervention includes social media engagement and peer navigation

Combination HIV treatment outcomes (retention, ART adherence and viral suppression) intervention includes SMS text messaging and peer navigation

Outcomes

Primary Outcome Measures

VIral suppression
Proportion of participants with viral suppression, defined as viral load (plasma HIV-1 RNA) <200 copies/ml

Secondary Outcome Measures

Antiretrovial adherence measured by pharmacy drug pick-up
Pharmacy drug pick-up (90% of days with medication)
Antiretroviral drug concentration
Antiretroviral drug concentration in Dried Blood Spot sufficient for viral suppression
Retention in care
Retention, defined as at least two care (non-study) visits in the prior 24-week period

Full Information

First Posted
June 25, 2021
Last Updated
September 22, 2023
Sponsor
Northwestern University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04950153
Brief Title
Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase
Acronym
iCARE
Official Title
Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent HIV Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stepped wedge (cluster) randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV Testing Intervention
Arm Type
Other
Arm Description
Combination HIV testing and linkage to care intervention includes social media engagement and peer navigation
Arm Title
HIV Treatment Intervention
Arm Type
Other
Arm Description
Combination HIV treatment outcomes (retention, ART adherence and viral suppression) intervention includes SMS text messaging and peer navigation
Intervention Type
Behavioral
Intervention Name(s)
Peer navigation
Intervention Description
Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)
Intervention Type
Behavioral
Intervention Name(s)
SMS Text messaging
Intervention Description
Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART
Intervention Type
Behavioral
Intervention Name(s)
Social Media Engagement
Intervention Description
HIV testing outreach using social media platforms to promote HIV testing.
Intervention Type
Behavioral
Intervention Name(s)
Testing Peer Navigation
Intervention Description
Peer navigators will conduct HIV testing outreach and linkage to care to at-risk youth
Primary Outcome Measure Information:
Title
VIral suppression
Description
Proportion of participants with viral suppression, defined as viral load (plasma HIV-1 RNA) <200 copies/ml
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Antiretrovial adherence measured by pharmacy drug pick-up
Description
Pharmacy drug pick-up (90% of days with medication)
Time Frame
Week 48
Title
Antiretroviral drug concentration
Description
Antiretroviral drug concentration in Dried Blood Spot sufficient for viral suppression
Time Frame
Week 48
Title
Retention in care
Description
Retention, defined as at least two care (non-study) visits in the prior 24-week period
Time Frame
Week 48
Other Pre-specified Outcome Measures:
Title
HIV testing and seroprevalence among young men across multiple sites
Description
HIV seroprevalence among the tested young men during the intervention period (the number of confirmed HIV cases divided by the total number of tests).
Time Frame
Week 48
Title
Linkage of newly diagnosed young men to a clinic for ART
Description
Percentage of young men who are linked to HIV care within 30 days of an HIV confirmatory test
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babafemi Taiwo, MBBS
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Garofalo, MD
Organizational Affiliation
Ann & Robert Lurie Childrens Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ibadan
City
Ibadan
Country
Nigeria
Facility Name
Jos University Teaching Hospital
City
Jos
Country
Nigeria
Facility Name
Lagos State University Teaching Hospital
City
Lagos
Country
Nigeria
Facility Name
Lagos University Teaching Hospital
City
Lagos
Country
Nigeria
Facility Name
Nigerian Institute of Medical Research (NIMR)
City
Lagos
Country
Nigeria
Facility Name
Olabisi Onabanjo University Teaching Hospital
City
Sagamu
Country
Nigeria

12. IPD Sharing Statement

Learn more about this trial

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

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