Adolescent HIV InfectioniCARE PlusNCT06880224
Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study
A study testing Testing Peer navigation, PrEP Intervention and Treatment Peer Navigation in people with Adolescent HIV Infection, run by Northwestern University at 6 sites in Nigeria.
Trial summary
Two combination interventions (HIV Case Finding Intervention and HIV Treatment Intervention), each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent HIV Infection
- What is being tested?
- Testing Peer navigation, PrEP Intervention and Treatment Peer Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 6 sitesNigeria
- Study dates
- 1 Feb 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV Case Finding Intervention:
- Aged 15 to 24
- Male birth sex of any current gender identity
- Understand basic English, Yoruba, Hausa, Igbo or Pidgin English For the PrEP component, must also be HIV-negative
- HIV Treatment Intervention:
- Aged 15 to 24
Show all 10Show fewer
- HIV seropositive
- Initiating ART for the first time at a Clinical Research Performance Site (CRPS) clinic or satellite clinic
- Understand basic English, Yoruba, Hausa, Igbo or Pidgin English
- Intention to remain a CRPS patient during follow-up
Who cannot join
- Unable to provide consent
- No parental permission if aged 15 and not emancipated
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Nigeria6 sites, 6 recruiting
- Recruiting
University of Nigeria Teaching Hospital
Enugu
Chinwe Chukwuka, MBBS, 234, chinwechukwuka@yahoo.com
- Recruiting
Taraba State Specialist Hospital
Jalingo, Taraba State
Dashe Dasogot, MBBS, 234, dashedr@gmail.com
- Recruiting
Aminu Kano Teaching Hospital
Kano
Musa Babashani, MBBS, 234, babashanim@yahoo.com
- Recruiting
Lagos University Teaching Hospital
Lagos
Sulaimon Akanmu, MBBS, 234, asulaimona@gmail.com
- Recruiting
Federal Medical Center
Makurdi, Benue State
Bem Tar, MBBS, 234, drbemtar@gmail.com
- Recruiting
University of Uyo Teaching Hospital
Uyo, Akwa Ibom State
Ofonime Dixon-Umo, MBBS, 234, ofonimedixonumo@uniuyo.edu.ng
About this study
Official title: Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study: Aim 2
Two combination interventions (HIV Case Finding Intervention and HIV Treatment Intervention), each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria.
Read the detailed description
Two combination interventions, each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria:
- HIV Case Finding Intervention: single arm trial of an HIV case finding and linkage to care intervention targeting young men at risk of HIV infection (n = 6000), particularly young men who have sex with men (YMSM) in Akwa Ibom, Benue, Enugu, Kano, Taraba, and Lagos states who complete HIV testing. Objectives: To determine the effectiveness of the intervention to:
- identify youth living with HIV, particularly YMSM and
- link those who test HIV-positive to HIV care
- pre-exposure prophylaxis (PrEP) initiation (uptake) among those who test HIV-negative.
- HIV Treatment Intervention: randomized controlled trial of a medication adherence and viral suppression intervention among youth newly diagnosed with HIV and initiating antiretroviral therapy (ART) for the first time (n = 600) at the participating clinical sites.
Objectives: To determine the effectiveness of the intervention on
- viral suppression and
- adherence to ART
- success of implementation in the target populations
- Conditions
- Adolescent HIV Infection
- Being tested
- Testing Peer navigation, PrEP Intervention, Treatment Peer Navigation, Social Media Outreach, SMS Test messaging
- Keywords
- Adolescents, HIV Testing, HIV Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing Peer navigationBehavioural
Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive
PrEP InterventionBehavioural
Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative
Treatment Peer NavigationBehavioural
Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART
Social Media OutreachBehavioural
Social media outreach to identify youth at risk for HIV
SMS Test messagingBehavioural
Text (SMS) messages to remind and encourage youth to adhere to their ART
Adherence standard of careOther
Standard of care HIV treatment adherence
| Study group | Role | What they receive |
|---|---|---|
| HIV Case Finding Intervention | Experimental | Combination HIV case finding and linkage to care intervention Receives: Behavioral: Testing Peer navigation; Behavioral: PrEP Intervention; Behavioral: Social Media Outreach |
| HIV Treatment Intervention | Experimental | Combination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART Receives: Behavioral: Treatment Peer Navigation; Behavioral: SMS Test messaging; Other: Adherence standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case Finding: HIV-positive serostatus
HIV-positive serostatus based on rapid test with confirmation
Measured: 48 weeks
Treatment: Viral suppression
Viral suppression (< 200 copies per mL)
Measured: 48 Weeks
Secondary outcomes (3)
Case Finding: Linkage to HIV care
Linkage to HIV care within 30 days of positive HIV test
Measured: 48 Weeks
Case Finding: PrEP among youth who test HIV-negative
PrEP uptake among youth who test HIV-negative
Measured: 48 weeks
Treatment: Adherence to antiretroviral therapy (ART)
> 90% adherence to ART
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Feb 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent HIV InfectionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a hybrid effectiveness/implementation trial with an HIV Case Finding Intervention "Arm" and a parallel HIV Treatment Intervention "Arm" that is a randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Robert Garofalo, Northwestern University
- Investigators
- Robert Garofalo, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880224
- Sponsor's protocol ID
- iCARE Plus
- Other IDs
- UG1HD113160
- Acronym
- iCARE Plus
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study: Aim 2
- ClinicalTrials.gov ID
- NCT06880224
- Acronym / sponsor ID
- iCARE Plus / iCARE Plus
- Conditions
- Adolescent HIV Infection
- Keywords
- Adolescents, HIV Testing, HIV Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two combination interventions (HIV Case Finding Intervention and HIV Treatment Intervention), each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria.
Detailed description
Two combination interventions, each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria:
- HIV Case Finding Intervention: single arm trial of an HIV case finding and linkage to care intervention targeting young men at risk of HIV infection (n = 6000), particularly young men who have sex with men (YMSM) in Akwa Ibom, Benue, Enugu, Kano, Taraba, and Lagos states who complete HIV testing. Objectives: To determine the effectiveness of the intervention to:
- identify youth living with HIV, particularly YMSM and
- link those who test HIV-positive to HIV care
- pre-exposure prophylaxis (PrEP) initiation (uptake) among those who test HIV-negative.
- HIV Treatment Intervention: randomized controlled trial of a medication adherence and viral suppression intervention among youth newly diagnosed with HIV and initiating antiretroviral therapy (ART) for the first time (n = 600) at the participating clinical sites.
Objectives: To determine the effectiveness of the intervention on
- viral suppression and
- adherence to ART
- success of implementation in the target populations
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a hybrid effectiveness/implementation trial with an HIV Case Finding Intervention "Arm" and a parallel HIV Treatment Intervention "Arm" that is a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| HIV Case Finding Intervention | Experimental | Behavioral: Testing Peer navigation, Behavioral: PrEP Intervention, Behavioral: Social Media OutreachCombination HIV case finding and linkage to care intervention |
| HIV Treatment Intervention | Experimental | Behavioral: Treatment Peer Navigation, Behavioral: SMS Test messaging, Other: Adherence standard of careCombination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Aged 15 to 24
- Male birth sex of any current gender identity
- Understand basic English, Yoruba, Hausa, Igbo or Pidgin English For the PrEP component, must also be HIV-negative
- Aged 15 to 24
- HIV seropositive
Key exclusion criteria (2 listed)
- Unable to provide consent
- No parental permission if aged 15 and not emancipated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing Peer navigationPeer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive | Behavioural | HIV Case Finding Intervention |
| PrEP InterventionMotivational-interviewing to promote uptake of PrEP among those who test HIV-negative | Behavioural | HIV Case Finding Intervention |
| Treatment Peer NavigationPeer navigators will provide assistance and support to youth with HIV to optimize adherence to ART | Behavioural | HIV Treatment Intervention |
| Social Media OutreachSocial media outreach to identify youth at risk for HIV | Behavioural | HIV Case Finding Intervention |
| SMS Test messagingText (SMS) messages to remind and encourage youth to adhere to their ART | Behavioural | HIV Treatment Intervention |
| Adherence standard of careStandard of care HIV treatment adherence | Other | HIV Treatment Intervention |
Primary outcome
Case Finding: HIV-positive serostatus
Time frame: 48 weeks
HIV-positive serostatus based on rapid test with confirmation
Treatment: Viral suppression
Time frame: 48 Weeks
Viral suppression (< 200 copies per mL)
3 secondary outcomes
Case Finding: Linkage to HIV care
Time frame: 48 Weeks
Case Finding: PrEP among youth who test HIV-negative
Time frame: 48 weeks
Treatment: Adherence to antiretroviral therapy (ART)
Time frame: 48 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Garofalo, MD principal investigator
Northwestern University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing Peer navigation, PrEP Intervention and Treatment Peer Navigation in people with Adolescent HIV Infection, run by Northwestern University at 6 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Garofalo, MD (312-227-7740, rgarofalo@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Case Finding: HIV-positive serostatus (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.