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

Northwestern University

Status: Not yet enrolling

Conditions: HIV

Treatments: Behavioral: Combination Peer navigation and mHealth intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06190613

iCARE R34

1R34MH132453 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 15 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Combination peer navigation and mHealth Intervention

Other group

Description:

Peer navigation and SMS text message medication reminders

Treatment:

Behavioral: Combination Peer navigation and mHealth intervention

Control

No Intervention group

Description:

standard of care