HIV
Conditions
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.
Interventions
BEHAVIORALCombination Peer navigation and mHealth intervention
Peer navigation and SMS text message medication reminders (adapted to YMSM and YTW in community outreach-based delivery approach)
Sponsors
Northwestern University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
15 Years to 29 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV viral load suppression | Baseline, 24 weeks | Viral load suppression (\<200 copies/mL) at baseline and 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention in HIV care | Baseline, 24 weeks | Two medical visits in the 24-week study period, with a minimum of 60 days between visits |
| Medication adherence | Baseline, 24 weeks | Self-reported measure of adherence on visual analogue scale (0-100), with adherence measured as \>or = 90% |
| Feasibility of intervention | 24 weeks | Phone-related and SMS text-related problems resulting in \<10% message failure, measured by text message platform administrative reports |
| Acceptability of intervention | 24 weeks | Acceptability report of \>90% agreement based on Client Satisfaction Questionnaire-8 (CSQ-8) |
Countries
Nigeria
Contacts
CONTACTLisa Kuhns, PhD
PRINCIPAL_INVESTIGATORLisa Kuhns, PhD
Northwestern University
Outcome results
None listed