Information Seeking About Pre-exposure Prophylaxis

Sponsor
Penn State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05728034
Collaborator
(none)
675
1
2
23
29.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Injectable PrEP information
  • Behavioral: Oral PrEP information
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
675 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Information Seeking About Pre-exposure Prophylaxis Among Men Who Have Sex With Men
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

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.

Behavioral: Injectable PrEP information
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.

Behavioral: Oral PrEP information
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.

Outcome Measures

Primary Outcome Measures

  1. Browsing behavior - First click [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.

  2. Browsing behavior - Total page duration [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.

  3. Visual behavior - Total fixation duration (Study 2 only) [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.

Secondary Outcome Measures

  1. Change in intention to adopt PrEP [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.

  2. Open-ended responses [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 34 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pennsylvania State University University Park Pennsylvania United States 16802

Sponsors and Collaborators

  • Penn State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chris Skurka, PhD, Assistant Professor, Penn State University
ClinicalTrials.gov Identifier:
NCT05728034
Other Study ID Numbers:
  • STUDY00021859
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 14, 2023