NCT06190613

Brief Summary

The study will adapt and test a combination peer navigation and mHealth approach, Intensive Combination Approach to Rollback the Epidemic in Nigeria (iCARE Nigeria), to improve HIV treatment engagement, medication adherence and viral suppression among YMSM and YTW, ages 15-29.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
3mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

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 Progress84%
Nov 2024Aug 2026

First Submitted

Initial submission to the registry

December 13, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

November 28, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

December 13, 2023

Last Update Submit

March 25, 2026

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • HIV viral load suppression

    Viral load suppression (\<200 copies/mL) at baseline and 24 weeks

    Baseline, 24 weeks

Secondary Outcomes (4)

  • Retention in HIV care

    Baseline, 24 weeks

  • Medication adherence

    Baseline, 24 weeks

  • Feasibility of intervention

    24 weeks

  • Acceptability of intervention

    24 weeks

Study Arms (2)

Combination peer navigation and mHealth Intervention

OTHER

Peer navigation and SMS text message medication reminders

Behavioral: Combination Peer navigation and mHealth intervention

Control

NO INTERVENTION

standard of care

Interventions

Combination Peer navigation and mHealth interventionBEHAVIORAL

Peer navigation and SMS text message medication reminders (adapted to YMSM and YTW in community outreach-based delivery approach)

Combination peer navigation and mHealth Intervention

Eligibility Criteria

Age15 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsidentify as YMSM or YTW
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV seropositive
  • registered as a patient at one of the collaborating key population (KP)-focused community centers
  • male sex at birth
  • identify as YMSM or YTW (or report a history of sex with men)
  • on ART for at least 3 months
  • understand and read basic English, Yoruba, or Pidgin English
  • intention to remain a patient at a collaborating clinic during the 24-week follow-up period
  • has a cellphone

You may not qualify if:

  • Unable to obtain parental permission if 15 years of age and not emancipated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ibadan

Ibadan, Nigeria

RECRUITING

Study Officials

  • Lisa Kuhns, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Kuhns, PhD

CONTACT

312-227-7760lkuhns@luriechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2023

First Posted

January 5, 2024

Study Start

November 28, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

NG(1)