Evaluation of Long Acting Injectable (LAI) and Teen clubs in adolescents (ATTUNE)

Summary

This project evaluates the effectiveness and implementation of peer navigation and long-acting injectable antiretroviral therapy (LAI ART) for adolescents living with HIV in South Africa, using a hybrid effectiveness implementation design.

What they want

The study employs a Type I hybrid effectiveness implementation design, utilizing a stepped-wedge, delayed implementation cluster randomized clinical trial to compare peer navigation with standard of care for viral suppression and retention (Aim 1). A nested individually randomized clinical trial will then evaluate LAI ART effectiveness on retention and viral suppression among virally suppressed adolescents (Aim 2). Concurrently, the RE-AIM framework will assess implementation factors related to peer navigators as clinic champions and audit and feedback strategies (Aim 3).

Deliverables

Viral suppression rates data
Retention in care data
Evaluation of LAI ART effectiveness
Assessment of implementation factors
Research findings and publications

Technical requirements

Type I hybrid effectiveness implementation design
Stepped-wedge, delayed implementation cluster randomized clinical trial design
Nested individually randomized clinical trial design
RE-AIM framework

Key personnel

Multiple Principal Investigators (e.g., Brian Zanoni, Moherndran Archary)
Co-investigators (e.g., Maryam Shahmanesh, Lee Fairlie, Kathy Baisley)
Experts in adolescent HIV
Experts in pediatric and adolescent HIV
Experts in clinical trials among youth
Experts in implementation science
Senior statistician with expertise in clinical trials including stepped-wedge designs

How they evaluate

Viral suppression rates (primary outcome for Aim 1 and Aim 2)
Retention in care (primary outcome for Aim 1 and Aim 2)
Implementation factors measured using the RE-AIM framework (Aim 3)