Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03896776 |
Other study ID # |
R01MH118213 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 9, 2019 |
Est. completion date |
March 31, 2023 |
Study information
Verified date |
July 2023 |
Source |
Northwestern University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study evaluates and compares two implementation strategies of an online HIV prevention
intervention: Strategy 1 in which community-based organizations apply, and are selected, for
funding to deliver Keep It Up! through current HIV testing programs; and Strategy 2 which is
a "direct-to-consumer" model where centralized staff at Northwestern University recruit
participants nationally through online advertising campaigns and manage engagement.
Description:
Substantial effort has gone into developing and testing the efficacy of eHealth HIV
prevention interventions, but these interventions will not affect the spread of the epidemic
unless implemented effectively to reach the most at-risk populations. Despite emerging
evidence that eHealth approaches can be highly effective in reducing HIV risk or improving
care engagement, 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. To date, little to no implementation science has examined strategies to effectively
scale up eHealth HIV prevention programs.
The overarching goal of this study 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 diverse young men who have sex with men (YMSM). KIU!
was designed for YMSM who just tested HIV negative to keep it up and maintain negative status
by reducing risk and enacting protections. Strong evidence of effectiveness on behavioral
(decreased condomless sex) and biomedical outcomes (reduced STI incidence) makes KIU! an
ideal eHealth intervention for implementation research. Lessons learned from KIU!
implementation will set the pathway for implementing the many HIV eHealth programs currently
undergoing efficacy testing.
Implementation strategies need to be evaluated using rigorous research designs. Through
formative research with community-based organizations (CBOs), health departments, the CDC,
and researchers, the investigators have identified two pragmatic implementation strategies
that will be evaluated and compared:
In Strategy 1, CBOs apply for, and are selected for, funding to deliver KIU! through current
HIV testing programs. Because CBOs do not have the capacity to host the technology, KIU! is
hosted centrally at Northwestern and deployed by local CBO staff. Training and coaching of
CBO staff on how to use the technology and integrate it into routine HIV testing is provided
through capacity building assistance.
Strategy 2 is a "direct-to-consumer" (DTC) model where centralized staff at Northwestern
primarily recruit participants nationally through online advertising campaigns and manage
participants' engagement. HIV/STI testing kits are shipped directly to YMSM, and upon
documentation of an HIV negative test result, participants are delivered KIU! This DTC model
has been widely adopted in technology dissemination but it is innovative in terms of
implementation of HIV prevention programs.
The investigators will accomplish the goal to inform eHealth intervention implementation with
two specific aims:
Aim 1: Compare two implementation strategies using a quasi-experimental trial.
The investigators selected a type III hybrid implementation-effectiveness design, which
prioritizes empirical comparison of implementation strategies while also collecting evidence
of effectiveness. KIU will be delivered using Strategy 1 (CBOs) in 22 counties for two years;
simultaneously, the investigators will deliver KIU nationally using Strategy 2 (DTC). YMSM
participants in the DTC strategy will be matched to CBO strategy participants based on
post-hoc propensity scores. Implementation and effectiveness outcome data will be collected
from YMSM participants, CBOs, and the technology vendor. The primary outcomes are public
health impact (defined as reach X effectiveness) and cost per infection averted, a key
component of CDC decision making about which HIV prevention programs will be supported. There
continues to be equipoise for the trial (i.e., either strategy could be superior). Because
implementation success can be defined differently for different stakeholders, the
investigators will also continue to collect and report as secondary outcomes multiple metrics
of reach, effectiveness, and implementation.
Aim 2: Examine adoption characteristics that explain variability in implementation outcomes.
There is remarkable variability in implementation success when CBOs adopt evidence-based
interventions. The investigators will seek to explain variability in implementation success
across counties by conducting mixed-methods research on the domains from the consolidated
framework for implementation research (CFIR), such as county characteristics, adaptations,
support from organization leadership, and approach to planning adoption. Data on CFIR
characteristics will be collected through administrative data, surveys, and telephone
interviews with key stakeholders.
In addition to these 2 specific aims, the investigators will explore 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. The investigators will also examine factors that predict
applying for funding and ongoing sustainment. For Strategy 2, through consultation with the
CDC, capacity building assistance providers, health departments, and small businesses
involved in Health 2.0 initiatives, the investigators will examine models for ongoing
sustainment of the DTC model.