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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04032106
Other study ID # OSU-19028
Secondary ID NCI-2019-01223R3
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 3, 2019
Est. completion date March 31, 2025

Study information

Verified date May 2024
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase III trial studies how well the Outsmart HPV intervention works in increasing HPV vaccine initiation and completion among young individuals who report having a history of same-sex partners, being sexually attracted to males, or identify as gay, bisexual, or queer (i.e., sexual minority males). The Outsmart HPV intervention, which is a population-targeted, individually-tailored mHealth intervention that includes vaccine reminders, may increase HPV vaccine initiation and completion among unvaccinated young sexual minority individuals.


Description:

PRIMARY OBJECTIVES: I. Determine the efficacy of the Outsmart HPV intervention on increasing HPV vaccine initiation and completion. II. Identify mediators that explain the relationship between study arm and HPV vaccine initiation and completion. III. Determine if intervention efficacy differs across key demographic and health-related characteristics of participants. OUTLINE: Participants are randomized to 1 of 3 groups. GROUP A: Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website. GROUP B: Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond). GROUP C: Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond). Participants in all study group are followed for 9 months.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1227
Est. completion date March 31, 2025
Est. primary completion date March 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Cisgender male - Ages 18-25 - Sexual minority (reports ever having oral or anal sex with a male or being sexually attracted to males; or identifies as gay, bisexual, or queer) - Lives in the United States (US) - Has not received any doses of HPV vaccine - Did not participate in the pilot study - Read English - Able to provide informed consent (inferred by completing the screener survey and consent form)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Best Practice
Receive standard information about HPV and HPV vaccine
Informational Intervention
Receive Outsmart HPV intervention
Questionnaire Administration
Ancillary studies
Behavioral:
Text Message-Based Intervention
Receive unidirectional text message vaccine reminders
Text Message-Based Intervention
Receive interactive text message vaccine reminders

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Human Papillomavirus (HPV) Vaccine Initiation and Completion Number and proportion of participants who initiate and complete the HPV vaccine series during the study period Baseline up to 9 months
Primary Changes in Theoretical Constructs Changes in theoretical constructs from baseline to follow-up as assessed by study surveys. Survey items developed by the study team were used to assess changes in perceived severity of HPV-related disease (possible range of -3 to 3), response efficacy of HPV vaccine (possible range of -4 to 4), and worry about getting HPV-related disease (possible range of -3 to 3). The reported numbers represent the mean change for each construct that occurred from baseline to follow-up. For each construct, a score of 0 represents no change between survey timepoints. Change scores greater than 0 indicate an increase in that construct between survey timepoints, with more positive values indicating a greater amount of change. Change scores less than 0 indicate an decrease in that construct between survey timepoints, with more negative values indicating a greater amount of change. Baseline up to 9 months
Primary Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys Baseline up to 9 months
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