A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
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ClinicalTrials.gov Identifier: NCT03896776 |
Recruitment Status :
Recruiting
First Posted : April 1, 2019
Last Update Posted : July 29, 2020
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Tracking Information | |||||||||
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First Submitted Date ICMJE | March 28, 2019 | ||||||||
First Posted Date ICMJE | April 1, 2019 | ||||||||
Last Update Posted Date | July 29, 2020 | ||||||||
Actual Study Start Date ICMJE | October 9, 2019 | ||||||||
Estimated Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Public Health Impact (reach X effectiveness) [ Time Frame: 12 Months ] Public Health Impact (PHI) involves the reach into the county's YMSM community, weighted by HIV risk (i.e., engagement of YMSM from higher risk communities is valued more), and effectiveness at reducing HIV risk, defined as condomless anal sex, STIs, and adherent PrEP use (i.e., three major risk factors for HIV expected to be modified by KIU!).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0) | ||||||||
Official Title ICMJE | A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0) | ||||||||
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 cluster randomized trial. The investigators selected a type III hybrid implementation-effectiveness design, which prioritizes empirical comparison of implementation strategies while also collecting evidence of effectiveness. The 75 counties with the largest YMSM populations will be randomized 2:1 to either 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. 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. 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Keep It Up! 3.0
KIU! is an online HIV prevention intervention developed for high-risk young men who have sex with men (YMSM) who recently tested HIV negative. Content was developed in collaboration with YMSM-serving CBOs and subjected to usability testing with diverse YMSM. The Information-Motivation-Behavioral Skills model and eLearning principles guided development of highly interactive, engaging, and culturally relevant health messages. KIU! involves 7 modules completed across 3 sessions done at least 24 hours apart, totaling ~1 hour of main content, plus 2 booster sessions at 3- and 6-month follow-ups. Each module is based on a setting or situation relevant to YMSM (e.g., connecting to the gay community and meeting guys through apps), with developmentally appropriate behavior change content embedded. KIU! uses diverse delivery methods (e.g. videos, animation, games) to address HIV knowledge gaps, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors.
Other Name: KIU! 3.0
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
4400 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 2023 | ||||||||
Estimated Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 29 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT03896776 | ||||||||
Other Study ID Numbers ICMJE | R01MH118213( U.S. NIH Grant/Contract ) | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Brian Mustanski, Northwestern University | ||||||||
Study Sponsor ICMJE | Northwestern University | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Northwestern University | ||||||||
Verification Date | July 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |