NCT06880224

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Feb 2025Aug 2028

Study Start

First participant enrolled

February 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

March 11, 2025

Last Update Submit

April 6, 2026

Conditions

Adolescent HIV Infection

Keywords

Adolescents, HIV Testing, HIV Treatment

Outcome Measures

Primary Outcomes (2)

  • Case Finding: HIV-positive serostatus

    HIV-positive serostatus based on rapid test with confirmation

    48 weeks

  • Treatment: Viral suppression

    Viral suppression (\< 200 copies per mL)

    48 Weeks

Secondary Outcomes (3)

  • Case Finding: Linkage to HIV care

    48 Weeks

  • Case Finding: PrEP among youth who test HIV-negative

    48 weeks

  • Treatment: Adherence to antiretroviral therapy (ART)

    48 Weeks

Study Arms (2)

HIV Case Finding Intervention

EXPERIMENTAL

Combination HIV case finding and linkage to care intervention

Behavioral: Testing Peer navigationBehavioral: PrEP InterventionBehavioral: 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

Behavioral: Treatment Peer NavigationBehavioral: SMS Test messagingOther: Adherence standard of care

Interventions

Testing Peer navigationBEHAVIORAL

Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive

HIV Case Finding Intervention
PrEP InterventionBEHAVIORAL

Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative

HIV Case Finding Intervention
Treatment Peer NavigationBEHAVIORAL

Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART

HIV Treatment Intervention
Social Media OutreachBEHAVIORAL

Social media outreach to identify youth at risk for HIV

HIV Case Finding Intervention
SMS Test messagingBEHAVIORAL

Text (SMS) messages to remind and encourage youth to adhere to their ART

HIV Treatment Intervention
Adherence standard of careOTHER

Standard of care HIV treatment adherence

HIV Treatment Intervention

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Unable to provide consent
  • No parental permission if aged 15 and not emancipated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Uyo Teaching Hospital

Uyo, Akwa Ibom State, Nigeria

RECRUITING

Federal Medical Center

Makurdi, Benue State, Nigeria

RECRUITING

Taraba State Specialist Hospital

Jalingo, Taraba State, Nigeria

RECRUITING

University of Nigeria Teaching Hospital

Enugu, Nigeria

RECRUITING

Aminu Kano Teaching Hospital

Kano, Nigeria

RECRUITING

Lagos University Teaching Hospital

Lagos, Nigeria

RECRUITING

Study Officials

  • Robert Garofalo, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Garofalo, MD

CONTACT

312-227-7740rgarofalo@luriechildrens.org

Lisa M Kuhns, PhD

CONTACT

312-227-7740lkuhns@luriechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

NG(6)