# A pragmatic trial of two strategies for implementing an effective eHealth HIV prevention program

> **NIH NIH R01** · NORTHWESTERN UNIVERSITY · 2021 · $1,510,118

## Abstract

Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation
requirements do not fit within established strategies for public health scale up—leaving it an open question as
to how to bring these programs into practice. The overarching goal of this proposal is to address this need by
developing and evaluating novel strategies for implementing eHealth HIV prevention programs. Keep It Up!
(KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM),
including YMSM at elevated HIV risk due to behaviors (i.e., condomless sex, substance use) and
demographics (i.e., racial/ethnic minorities). Strong evidence of effectiveness on behavioral and biomedical
outcomes makes KIU! an ideal eHealth intervention for implementation science. Lessons learned will set the
pathway for implementation of the many HIV eHealth programs currently undergoing efficacy testing.
 Through formative research with community-based organizations (CBOs), health departments, the
CDC, and researchers we have identified two pragmatic implementation strategies that we will evaluate and
compare: Strategy 1: CBOs apply for, and are selected for, funding to deliver KIU! through their current HIV
testing programs. Strategy 2 is a “direct-to-consumer” (DTC) model where centralized staff recruit participants
nationally through online advertising campaigns and manage engagement. HIV/STI testing kits are shipped
directly to YMSM and, upon documentation of an HIV negative test result, participants are delivered KIU!
 Aim 1: Compare two implementation strategies using a cluster randomized trial. 75 counties with
large YMSM populations will be randomized 2:1 to strategy 1 (CBO) or strategy 2 (DTC). KIU! will be delivered
in each county for two years. In this cluster randomized trial, the unit of randomization is the county, with
implementation and effectiveness outcome data collected from YMSM participants, CBOs, and the technology
vendor. Our primary outcomes are public health impact (defined as reach X effectiveness) and cost per
infection averted. We will also collect and report as secondary outcomes multiple metrics of reach,
effectiveness, and implementation.
 Aim 2: Examine adoption characteristics that explain variability in implementation outcomes.
We will conduct mixed-methods research on the domains from the consolidated framework for implementation
research (CFIR) to explain variability in implementation success. Data on CFIR characteristics will be collected
through administrative data, and surveys and telephone interviews with key stakeholders.
 We will also explore 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, including an Impact Tool to estimate local impact and costs. Through expert consultation we will
examine models for ongoing sustainment of the DTC mode...

## Key facts

- **NIH application ID:** 10176599
- **Project number:** 5R01MH118213-04
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Brian Mustanski
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,510,118
- **Award type:** 5
- **Project period:** 2018-08-20 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10176599

## Citation

> US National Institutes of Health, RePORTER application 10176599, A pragmatic trial of two strategies for implementing an effective eHealth HIV prevention program (5R01MH118213-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10176599. Licensed CC0.

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