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

Not Applicable

Recruiting

• Conditions: HIV
• Interventions: Behavioral: Combination Peer navigation and mHealth intervention

• Registration Number: NCT06190613
• Lead Sponsor: Northwestern University

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.

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 Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-05
• Study Start: 2024-11-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination peer navigation and mHealth Intervention	Combination Peer navigation and mHealth intervention	Peer navigation and SMS text message medication reminders

Primary Outcome Measures

Name	Time	Method
HIV viral load suppression	Baseline, 24 weeks	Viral load suppression (\<200 copies/mL) at baseline and 24 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Ibadan; 🇳🇬 Ibadan, Nigeria