The overarching goal of the Keep It Up! (KIU!) trial is to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! is an eHealth program proven to reduce HIV risk, STI rates, and condomless anal sex among young men who have sex with men (YMSM). Strong evidence of effectiveness on behavioral and biomedical outcomes makes KIU! an ideal eHealth intervention for implementation research. Lessons learned will set the pathway for implementation of the many eHealth HIV programs currently undergoing efficacy testing.
Through formative research, we identified two pragmatic implementation strategies:
- Strategy 1: Implementation at community-based organizations (CBOs) with a history of providing HIV testing and other prevention services to YMSM.
- Strategy 2: Creation of a “direct-to-consumer” (DTC) model wherein centralized staff recruit participants nationally through online advertising campaigns and manage engagement.
The KIU! trial explores the following Aims:
- Aim 1: Compare two implementation strategies (CBO vs DTC) using a cluster randomized trial.
Our primary outcomes are public health impact (defined as reach X effectiveness) and cost per infection averted. Secondary outcomes include multiple metrics of reach, effectiveness, and implementation.
- Aim 2: Examine adoption characteristics that explain variability in implementation outcomes.
Domains from the Consolidated Framework for Implementation Research (CFIR) will be used to conduct mixed-methods research to explain variability in implementation success.
- Exploratory Aim 3: Maintenance/sustainment of KIU! at the completion of the study.
CBOs will be provided with materials to facilitate applying for external funding to continue to provide KIU! after study completion. Through expert consultation, we will examine models for ongoing sustainment of the DTC model.
About Keep It Up!
- Designed with guidance from ethnically diverse YMSM
- Multimedia and interactive content delivery
- Teaches useful skills for real-life scenarios
- Highly rated by participants
- Easy to use
- Accessible online
- Reinforces and expands on information provided by HIV prevention workers in time-limited interactions
- Meets CDC’s prevention grant requirement to provide comprehensive HIV-related prevention services for HIV-negative persons
- Based on the Information–Motivation–Behavioral Skills Model for HIV Preventive Behavior and principles of e-learning
- Tested in 2 efficacy trials, 1 implementation trial, and counting
- Among 901 YMSM in 3 cities, significantly reduced recent condomless anal sex from 70% to 40% in the KIU! arm
- Reductions were maintained for 12 months post intervention
- This represented a 17% greater decrease than an active control arm
- Also reduced STI rates by 40% compared to the control
|KIU! 1.0 (2009 – 2010)||Pilot Randomized Controlled Trial||102 YMSM (ages 18-24) in Chicago||Read Results|
|KIU! 1.5 (2012 – 2014)||Service Implementation||343 YMSM (ages 15-24) in Chicago||Read Results|
|KIU! 2.0 (2013 – 2017)||Randomized Controlled Trial||901 YMSM (ages 18-29) in Chicago, NY and Atlanta||Read Results|
|KIU! 2.5 (2017 – Present)||Service Implementation||Ongoing in Jackson, MS||—|