Clinical trial NCT03896776: A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
Official title: A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Gonorrhea
Chlamydia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Boston Medical Center
name: Weill Medical College of Cornell University
name: Marquette University
First posted: 2019-04-01
Enrollment: 2125
Sex: MALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* recently received an HIV negative test result OR self-report negative or unknown HIV status
* speaks/reads English
* has an active email address

Exclusion Criteria:

* has not been on PrEP and adherent for 6 months prior

Primary outcomes:
measure: Public Health Impact (reach X effectiveness)
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Brian Mustanski, PhD
role: PRINCIPAL_INVESTIGATOR
References: