Combination Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination Peer navigation and mHealth intervention.
- Who it may be relevant to
- Registry conditions: HIV. Basic parameters: 15 years — 29 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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)
Primary outcome measures
- HIV viral load suppression [Time frame: Baseline, 24 weeks]
Secondary outcome measures (4)
- Retention in HIV care [Time frame: Baseline, 24 weeks]
- Medication adherence [Time frame: Baseline, 24 weeks]
- Feasibility of intervention [Time frame: 24 weeks]
- Acceptability of intervention [Time frame: 24 weeks]
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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Nigeria · 1 center
- University of Ibadan — Ibadan
Identifiers
NCT: NCT06190613 · iCARE R34 · 1R34MH132453