Clinical trial NCT06190613: Combination Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-01-05
Enrollment: 100
Sex: MALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: HIV viral load suppression
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Retention in HIV care
timeFrame: Baseline, 24 weeks
measure: Medication adherence
timeFrame: Baseline, 24 weeks
measure: Feasibility of intervention
timeFrame: 24 weeks
measure: Acceptability of intervention
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: University of Ibadan
Study officials:
affiliation: Northwestern University
name: Lisa Kuhns, PhD
role: PRINCIPAL_INVESTIGATOR
References: