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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 : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Boston Medical Center
Weill Medical College of Cornell University
Marquette University
Information provided by (Responsible Party):
Brian Mustanski, Northwestern University

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Gonorrhea Chlamydia Behavioral: Keep It Up! 3.0 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Community Based Organization (CBO) Delivery

CBOs will be selected through a Request for Proposal (RFP) process. The RFP will describe research and KIU! delivery activities to be conducted as part of the study and allowable budget to carry out the activities. The RFP will ask CBOs to describe past experience providing HIV services for YMSM. Selected CBOs will recruit participants into the intervention and encourage participants to complete each session of intervention content at baseline, 3 Month Follow-up, and 6 Month Follow-up.

Participants in the CBO delivery arm will receive baseline HIV and STI testing at a CBO. Participants will receive an at-home STI test kit at 12 Month Follow-up.

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

Experimental: Direct to Consumer (DTC) Delivery

In the DTC arm, participants will be recruited online via paid social media advertising (e.g., Facebook, Instagram). Advertisements will target placements by age, gender, sexual orientation, racial background, "likes" that are relevant to YMSM (e.g., local LGBT organizations, "out" celebrities), and location (i.e., target county). Dating/sex-seeking apps (e.g., Grindr) will also be used to recruit YMSM, using a similar advertising approach as social media. Study staff at Northwestern University will manage this recruitment process and encourage participants to complete each session of intervention content at baseline, 3 Month Follow-up, and 6 Month Follow-up.

Participants in the DTC delivery arm will receive at-home HIV and STI test kits at baseline. Participants will receive an at-home STI test kit at 12 Month Follow-up.

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




Primary Outcome Measures :
  1. 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!).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender men
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • recently received an HIV negative test result
  • had condomless anal sex with another man in the prior 6 months
  • resides in an eligible county
  • speaks/reads English
  • has an active email address

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896776


Contacts
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Contact: Brian Mustanski, PhD 312.503.5421 brian@northwestern.edu
Contact: Krystal Madkins, MPH 312.503.6529 krystal.madkins@northwestern.edu

Locations
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United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Brian Mustanski, PhD    312-503-5421    brian@northwestern.edu   
Contact: Krystal Madkins, MPH    312.503.6529    krystal.madkins@northwestern.edu   
Sponsors and Collaborators
Northwestern University
National Institute of Mental Health (NIMH)
Boston Medical Center
Weill Medical College of Cornell University
Marquette University
Investigators
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Principal Investigator: Brian Mustanski, PhD Northwestern University

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Responsible Party: Brian Mustanski, Director, Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University
ClinicalTrials.gov Identifier: NCT03896776     History of Changes
Other Study ID Numbers: R01MH118213 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The PI agrees to develop a de-identified database, codebook, and mechanism by which IPD could be shared with other investigators upon approval of the PI. Data will be available for request approximately 6 months after completion of the project. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analysis, the analytic plans, resources the requestors have to carry out the project, the proposed timeline, and distribution goals (manuscripts and/or grant application). The PI will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to undertake the request, how data will be protected/managed, and whether there are sufficient resources to honor the request. If any of these issues are problematic, the PI will attempt to negotiate a fair resolution with the interested parties and/or with NIH program staff.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gonorrhea
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections