Human Papilloma Virus Awareness Intervention

Intervention Toward Knowledge of Human Papillomavirus in Homosexual Males

Intervention aimed at increasing knowledge of the human papillomavirus in homosexual men as a means of preventing sexually transmitted diseases and controlling complications associated with the pathology.

Study Overview

• Status: Completed
• Conditions: Human Papilloma Virus (HPV)
• Intervention / Treatment: Behavioral: Safe and Protected Sex" intervention targeting HPV; Behavioral: Diptych of the Secretary of Health in Mexico

Detailed Description

Introduction: The World Health Organization reports a 21% prevalence of Human Papillomavirus (HPV) in men, with rates reaching 93% among homosexual men. This group exhibits specific characteristics, such as high rates of sexually transmitted infections (STIs) due to multiple partners and inconsistent condom use, along with limited knowledge about HPV. The intervention "Safe and Protected Sex", using a horizontal methodology, aims to address this health issue.

Objective: To evaluate the effect of the "Safe and Protected Sex" program on HPV knowledge among homosexual men.

Methodology: A quasi-experimental study with a test-retest design and convenience sampling. The sample size was calculated using n'Query Advisor 4.0, resulting in 20 homosexual men per group (n=40).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Puebla, Mexico, 72304
    • School of Nursing Benemérita Universidad Autonoma de Puebla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Males who self-identify as homosexual and/or bisexual.
• Engage in sexual relationships with individuals of the same sex.
• Willing to voluntarily participate in the study.
• Have provided informed consent.

Exclusion Criteria:

• Homosexual and/or bisexual males with a profession related to the healthcare field.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safe and protected sex intervention group; This study used the "Safe and Protected Sex" intervention, adapted and validated from an HIV prevention program to focus on HPV. The intervention consists of a single module with two stages aimed at increasing HPV knowledge by enhancing personal (self-determination) and social (controlled behavior) motivation. Module 1: "Nursing Consultation on HPV" This structured, planned process follows Corona and Kaltmeier's (2012) horizontal methodology, promoting self-care through social support and trust in nurse-patient dialogue. The goal is to provide counseling on HPV prevention and responsible sexual behavior while acknowledging participants' prior knowledge. Stage 1: 4.21-minute educational video, "HPV Fun Facts," uses persuasive narrative to explain HPV transmission, symptoms, complications, and prevention. Stage 2: 45-minute "Friendly Educational Guidance" session uses open-ended questions to explore participants' experiences, clarify misconceptions, and reinforce key information	Behavioral: Safe and Protected Sex" intervention targeting HPV; This study used the "Safe and Protected Sex" intervention (Báez et al., 2019), adapted and validated from an HIV prevention program to focus on HPV. The intervention consists of a single module with two stages aimed at increasing HPV knowledge by enhancing personal (self-determination) and social (controlled behavior) motivation. Module 1: "Nursing Consultation on HPV" This structured, planned process follows Corona and Kaltmeier's (2012) horizontal methodology, promoting self-care through social support and trust in nurse-patient dialogue. The goal is to provide counseling on HPV prevention and responsible sexual behavior while acknowledging participants' prior knowledge. Stage 1: A 4.21-minute educational video, "HPV Fun Facts," uses persuasive narrative to explain HPV transmission, symptoms, complications, and prevention. Stage 2: A 45-minute "Friendly Educational Guidance" session uses open-ended questions to explore participants' experiences.
Placebo Comparator: Placebo control group; For the QA, the baseline measurement (test) was performed once the participant arrived at the sexual health clinic of the School of Nursing with the use of an electronic device that contained the first link of the QuestionPro® platform; subsequently, the participant was given information related to HPV through the usual methodology (diptych) (See Appendix H) that the health system in Mexico carries out. Finally, the second measurement was performed after reading the diptych with the use of the electronic device and the second link of the QuestionPro® platform, prior to the application of the intervention.	Behavioral: Diptych of the Secretary of Health in Mexico; a brochure is provided with general information about the human papilloma virus in men, including the form of contagion, diagnosis, treatment and the use of condoms for prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of human papillomavirus	This Spanish-language questionnaire is intended to measure knowledge about HPV. It is structured by 38 questions, distributed in four dimensions: 1) causal agent of HPV (1, 2 and 3); 2) risk factors (4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15); 3) signs and symptoms (16, 17, 18, 19 and 20) and 4) prevention, diagnosis and treatment (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37 and 38). The structure for answering each of the questions is through a Likert-type scale, where three possible options are presented: A= true, B= false and C= don't know. To obtain the cut-off points of the instrument, percentiles (zero to 100) will be used, where Percentile 1 (P125) = no knowledge, Percentile 2 (P250) = insufficient knowledge, Percentile 3 (P375) = fair knowledge and Percentile 4 (P4100) = adequate knowledge	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Motivation	To measure personal motivation (self-determination), the Personal Motivation Questionnaire adapted to the Mexican context. It consists of 13 items, which address the preventive behaviors performed by the homosexual male as a result of an emotional-cognitive process, derived from the values and beliefs related to knowledge of HPV, which are manifested during the nursing consultation, through the intervention "Safe and Protected Sex". The response form is Likert type: 1= Strongly agree, 2=Significantly agree, 3= Agree, 4= Neither agree nor disagree, 5= Disagree, 6= Strongly disagree, 7= Strongly disagree, also the score ranges from 13 to 91 points, however for a better interpretation of the data the values are converted into a scale from 0 to 100, where high scores indicate a higher personal motivation during the nursing consultation. The validity of the instrument was through eight experts, which yielded a content validity index	1 month
social motivation	To measure social motivation (controlled behavior), the Social Motivation Questionnaire adapted to the Mexican context . It consists of 15 items, which deal with the actions that the homosexual male has derived from the social support perceived during the nursing consultancy with horizontal methodology, granted through the intervention "Safe and Protected Sex" directed towards HPV. The response form is Likert type: 1= Strongly agree, 2= Strongly agree, 3= Agree, 4= Neither agree nor disagree, 5= Disagree, 6= Strongly disagree, 7= Strongly disagree, also the score ranges from 15 to 105 points, however for a better interpretation of the data the values are converted into a scale from 0 to 100, where high scores indicate a higher extrinsic motivation during the nursing consultation.	1 month

Collaborators and Investigators

• Sponsor: Hospital Univeristario Benemerita Universidad Autonoma de Puebla
• Collaborators: Francisco Javier Báez Hernández
• Investigators: Study Director: Francisco Javier Baez Hernández, Doctor of nursing science, Benemérita Universidad Autónoma de Puebla

Publications and helpful links

General Publications

• Jeno LM, Raaheim A, Kristensen SM, Kristensen KD, Hole TN, Haugland MJ, Maeland S. The Relative Effect of Team-Based Learning on Motivation and Learning: A Self-Determination Theory Perspective. CBE Life Sci Educ. 2017 Winter;16(4):ar59. doi: 10.1187/cbe.17-03-0055.
• Grov C, Rendina HJ, Breslow AS, Ventuneac A, Adelson S, Parsons JT. Characteristics of men who have sex with men (MSM) who attend sex parties: results from a national online sample in the USA. Sex Transm Infect. 2014 Feb;90(1):26-32. doi: 10.1136/sextrans-2013-051094. Epub 2013 Sep 19.
• Cranston RD, Carballo-Dieguez A, Gundacker H, Richardson BA, Giguere R, Dolezal C, Siegel A, KunjaraNaAyudhya RP, Gomez K, Piper JM, Lama JR, McGowan I; MTN-017 Protocol Team. Prevalence and determinants of anal human papillomavirus infection in men who have sex with men and transgender women. Int J STD AIDS. 2019 Feb;30(2):154-162. doi: 10.1177/0956462418797864. Epub 2018 Oct 18.
• Barrios MC, Rodriguez LS, Pachon CM, Lugo EA. Educational Intervention on Human Papillomavirus in University Students. Indian J Community Med. 2019 Jul-Sep;44(3):213-216. doi: 10.4103/ijcm.IJCM_247_18.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): June 5, 2022

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: intervention; Knowledge; Homosexual me
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: SIEP/ME/112/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study continues in a phase of improvement and replication in different contexts to improve its generalization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No