Information Seeking About Pre-exposure Prophylaxis

Pre-exposure Prophylaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728034
• Other study ID #: STUDY00021859
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Penn State University
• Contact: Christofer J Skurka, PhD
• Phone: 814-863-1482
• Email: cjs7142[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 675
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-exposure Prophylaxis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rendina HJ, Whitfield TH, Grov C, Starks TJ, Parsons JT. Distinguishing hypothetical willingness from behavioral intentions to initiate HIV pre-exposure prophylaxis (PrEP): Findings from a large cohort of gay and bisexual men in the U.S. Soc Sci Med. 2017 Jan;172:115-123. doi: 10.1016/j.socscimed.2016.10.030. Epub 2016 Nov 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Browsing behavior - First click	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)
Primary	Browsing behavior - Total page duration	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)
Primary	Visual behavior - Total fixation duration (Study 2 only)	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	Change in intention to adopt PrEP	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
Secondary	Open-ended responses	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