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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06190613
• Other study ID #: iCARE R34
• Secondary ID: 1R34MH132453
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: January 2024
• Source: Northwestern University
• Contact: Babafemi Taiwo, MBBS
• Phone: +1-312-695-0009
• Email: b-taiwo[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 15-24.

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 15-24. 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 15-24 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 24 Years

Eligibility

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• HIV

Intervention

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)

Locations

Country	Name	City	State
Nigeria	University of Ibadan	Ibadan

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV viral load suppression	Viral load suppression (<200 copies/mL) at baseline and 24 weeks	Baseline, 24 weeks
Secondary	Retention in HIV care	Two medical visits in the 24-week study period, with a minimum of 60 days between visits	Baseline, 24 weeks
Secondary	Medication adherence	Self-reported measure of adherence on visual analogue scale (0-100), with adherence measured as >or = 90%	Baseline, 24 weeks
Secondary	Feasibility of intervention	Phone-related and SMS text-related problems resulting in <10% message failure, measured by text message platform administrative reports	24 weeks
Secondary	Acceptability of intervention	Acceptability report of >90% agreement based on Client Satisfaction Questionnaire-8 (CSQ-8)	24 weeks