Information Seeking About Pre-exposure Prophylaxis

September 19, 2023 updated by: Chris Skurka, PhD, Penn State University

Information Seeking About Pre-exposure Prophylaxis Among Men Who Have Sex With Men

The goal of these two intervention studies is to test promising health communication messaging strategies most likely to enhance Black, Hispanic, and non-Hispanic White YMSM's (young men who have sex with men's) engagement with online content about injectable and oral PrEP (pre-exposure prophylaxis). Participants will be asked to browse a mock Google results page featuring various kinds of PrEP information, and their browsing behavior will be unobtrusively logged. In Study 1, participants will be randomly assigned to browse for information about oral PrEP or browse for information about injectable PrEP. The design of Study 2 will be identical to Study 1 but will focus only on injectable PrEP content. In addition to browsing behavior, visual behavior data will also be collected in Study 2 with eye-trackers.

Study Overview

Detailed Description

Study 1 (online between-subjects experiment): An online sample of YMSM (N = 600) will be strategically recruited to partake in a web-based survey experiment following a mixed experimental design: 2 (PrEP type [between]: oral or injectable PrEP) X 5 (messaging strategy [within]: response efficacy, social norms, exemplar, celebrity, & basic information). The survey will begin by determining eligibility (self-report screener questions), gathering consent, and asking participants to self-report on several psychographic measures (PrEP awareness, knowledge, interest, and stigma). Participants will then be asked to interact with a mock Google results page featuring an array of information about PrEP. The survey will randomly assign participants to one of two versions of the mock Google search page: Half of participants (n = 300) will browse for information about oral PrEP, and the other half (n = 300) will browse for information about injectable PrEP. This browsing experience will unobtrusively log browsing data (clicks, page durations). Participants will be able to click on the links on the search results page (which reflect the five messaging strategies), visit those pages, and return to the main results page. After three minutes, participants will then be asked to self-report their intention to adopt PrEP. They will then be debriefed.

Study 2 (in-person within-subjects experiment): Interested participants will complete an initial screening questionnaire to ensure eligibility and then be linked to a separate survey to provide their contact information. Upon arrival to the study site, participants (N = 75) will begin by providing consent. They will then complete the same measures as Study 1 of PrEP interest, knowledge, and stigma. A research assistant will lead participants through a calibration activity to ensure the eye-trackers are able to track the participants' eye gaze. Participants will complete the same mock browsing experience as Study 1 with the exception that all participants will browse for information about injectable PrEP. The survey software will unobtrusively log browsing behavior (clicks, page durations) while eye-trackers will unobtrusively track visual behavior (fixations). Participants will then self-report their intent to use PrEP and be debriefed by a research assistant,

Study Type

Interventional

Enrollment (Estimated)

675

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christofer J Skurka, PhD
  • Phone Number: 814-863-1482
  • Email: cjs7142@psu.edu

Study Contact Backup

  • Name: Jessica Myrick, PhD
  • Phone Number: 814-863-0535
  • Email: jgm43@psu.edu

Study Locations

    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Recruiting
        • Pennsylvania State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Have an Internet-connectable device (Study 1 only)
  • Be 18-34 years of age
  • Identify as cisgender male
  • Identify as gay or bisexual
  • Be HIV negative
  • Have had anal sex in the past 6 months
  • Meet one of the following criteria: a. Have a sexual partner with HIV, b. Have inconsistent condom use, c. Have received an STI diagnosis in the last 6 months.

Exclusion Criteria:

  • Does not meet all of the criteria above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injectable PrEP information
A mock Google search results page with five search results that reflect five messaging strategies about injectable PrEP (response efficacy, social norms, exemplar, celebrity, and basic information), displayed in random order.
Participants will be able to click on the links on the search results page (which reflect the five messaging strategies about injectable PrEP), visit those pages, and return to the main results page.
Experimental: Oral PrEP information (Study 1 only)
A mock Google search results page with five search results that reflect five messaging strategies about oral PrEP (response efficacy, social norms, exemplar, celebrity, and basic information), displayed in random order.
Participants will be able to click on the links on the search results page (which reflect the five messaging strategies about oral PrEP), visit those pages, and return to the main results page.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Browsing behavior - First click
Time Frame: Recorded while participants complete the Google results browsing task (3 minutes max)
SoSciSurvey software will unobtrusively log the clicks participants will make on the different search results, with each search result reflecting a different messaging strategy (response efficacy, social norms, exemplar, celebrity, and basic information). Our analysis will focus on which search result/messaging strategy participants click on first as a behavioral indicator of message engagement.
Recorded while participants complete the Google results browsing task (3 minutes max)
Browsing behavior - Total page duration
Time Frame: Recorded while participants complete the Google results browsing task (3 minutes max)
SoSciSurvey software will unobtrusively log the amount of time (in seconds) participants spend on the different search results after clicking on it, with each search result reflecting a different messaging strategy (response efficacy, social norms, exemplar, celebrity, and basic information). Our analysis will focus on the total amount of time participants spend on the page for each of the different search results/messaging strategies as a behavioral indicator of message engagement.
Recorded while participants complete the Google results browsing task (3 minutes max)
Visual behavior - Total fixation duration (Study 2 only)
Time Frame: Recorded while participants complete the Google results browsing task (3 minutes max)
Total fixation duration can be defined as how long the eyes dwell on a particular object in one's field of vision. Total fixation duration will be recorded by mobile eye-trackers.
Recorded while participants complete the Google results browsing task (3 minutes max)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intention to adopt PrEP
Time Frame: Will be measured immediately after completing the browsing task
Self-reported change in intention to initiate PrEP, assessed on a 0-100 sliding scale (0 = definitely not, 100 = definitely yes). Thus, higher scores reflect greater intentions to use PrEP.
Will be measured immediately after completing the browsing task
Open-ended responses
Time Frame: Will be measured immediately after completing the browsing task
Participants will be given an opportunity to list any other thoughts and suggestions they have about the kinds of messaging strategies about injectable PrEP that might engage their attention.
Will be measured immediately after completing the browsing task

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christofer J Skurka, PhD, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00021859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The researchers will make all data, analysis syntax, and materials (e.g., stimuli, survey measures) publicly available in accordance with NIH data sharing policies as well as Penn State University's IRB guidelines. Quantitative data will be made available in a non-proprietary file format (e.g., CSV). The researchers will strip all data of any personally identifying information before sharing our data. All the collected data will be actively managed, redundantly archived, and ultimately shared with the broader scientific community by the Data Commons online repository. The Penn State Data Commons is a service administered by Penn State University that provides maintenance and open access sharing of research project data during and after the period of support for the project. The Data Commons was developed with the intent of helping researchers comply with grant-funding agency requirements. It supports dissemination and long-term preservation (management, use, and re-use) of data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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