Combination Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria

Adapting and Testing a Combination Peer Navigation and mHealth Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria

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.

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Behavioral: Combination Peer navigation and mHealth intervention

Detailed Description

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 young men who have sex with men (YMSM) and young transgender women (YTW), ages 15-29. The 24-week pilot study will randomize participants at a ratio of 1:1 to the intervention or control. The goals of the pilot study are to assess: a) whether the intervention worked as intended (initial efficacy); and b) the feasibility, satisfaction, and acceptability among the target population of YMSM and YTW receiving HIV care in the community setting.

Specific aims are to:

1. Adapt the iCARE Nigeria HIV clinic-based intervention to a community-based outreach approach for YMSM and YTW ages 15-29 in Ibadan, Nigeria. This process will be structured using best practices for adaptation of evidence-based intervention, including distillation of adaptable components and incorporation of feedback from stakeholders, following user-centered principles of iterative design.
2. In a randomized controlled trial, test the adapted iCARE intervention for initial efficacy, feasibility, satisfaction, and acceptability among YMSM and YTW in the key population (KP)-focused community settings. The primary outcome will be viral load suppression (viral load<200 copies/mL). Secondary outcomes include antiretroviral drug adherence, and treatment retention via abstraction of medical records.
3. Evaluate implementation indicators based on RE-AIM (reach, adoption, implementation, maintenance) to improve external validity and to inform sustainability and scalability of the adapted iCARE Nigeria intervention. A mixed methods approach will be used to collect data for implementation outcomes from interventionists, intervention participants, and representatives of KP-friendly community centers.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Kuhns, PhD; Phone Number: 312-227-7760; Email: lkuhns@luriechildrens.org

Study Locations

• Nigeria
  • Ibadan, Nigeria
    • Recruiting
    • University of Ibadan
    • Contact: Oluwatosin Awolude, MBBS; Phone Number: +234-8032222986; Email: tosinawolude@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; standard of care
Other: Combination peer navigation and mHealth Intervention; Peer navigation and SMS text message medication reminders	Behavioral: Combination Peer navigation and mHealth intervention; Peer navigation and SMS text message medication reminders (adapted to YMSM and YTW in community outreach-based delivery approach)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV viral load suppression	Viral load suppression (<200 copies/mL) at baseline and 24 weeks	Baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in HIV care	Two medical visits in the 24-week study period, with a minimum of 60 days between visits	Baseline, 24 weeks
Medication adherence	Self-reported measure of adherence on visual analogue scale (0-100), with adherence measured as >or = 90%	Baseline, 24 weeks
Feasibility of intervention	Phone-related and SMS text-related problems resulting in <10% message failure, measured by text message platform administrative reports	24 weeks
Acceptability of intervention	Acceptability report of >90% agreement based on Client Satisfaction Questionnaire-8 (CSQ-8)	24 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Lisa Kuhns, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: iCARE R34; 1R34MH132453 (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
• product manufactured in and exported from the U.S.: No