Combination Intervention to Enhance Treatment Engagement... | NCT06190613

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

NCT06190613

Sponsor

Northwestern University

Status

Recruiting

Last Update Posted

Mar 27, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Interventions

Combination Peer navigation and mHealth intervention

Countries

Nigeria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R34MH132453	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2024Actual

Primary Completion Date

Aug 31, 2026Estimated

Completion Date

Aug 31, 2026Estimated

First Submitted Date

Dec 13, 2023

First Submission Date that Met QC Criteria

Jan 2, 2024

First Posted Date

Jan 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 27, 2026Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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:

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.
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.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Combination Peer navigation and mHealth intervention	Behavioral	Peer navigation and SMS text message medication reminders (adapted to YMSM and YTW in community outreach-based delivery approach)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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%

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

identify as YMSM or YTW

Minimum Age

15 Years

Maximum Age

29 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lisa Kuhns, PhD	Contact	312-227-7760		lkuhns@luriechildrens.org

Overall Officials

Name	Affiliation	Role
Lisa Kuhns, PhD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Ibadan	Recruiting	Ibadan			Nigeria