Human Papilloma Virus Awareness Intervention

NCT06920589 | Completed

• 1 other identifier: SIEP/ME/112/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papilloma Virus (HPV)

Keywords

intervention; Knowledge; Homosexual me

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Personal Motivation

  1 month

• social motivation

  1 month

Study Arms (2)

Safe and protected sex intervention group

EXPERIMENTAL

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

Placebo control group

PLACEBO COMPARATOR

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

Interventions

Safe and Protected Sex" intervention targeting HPV BEHAVIORAL

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.

Safe and protected sex intervention group

Diptych of the Secretary of Health in Mexico BEHAVIORAL

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.

Placebo control group

Eligibility Criteria

• Gender Eligibility Details: Men who identified themselves as homosexual males were considered to be
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Univeristario Benemerita Universidad Autonoma de Puebla: lead
• Francisco Javier Báez Hernández: collaborator

Study Sites (1)

School of Nursing Benemérita Universidad Autonoma de Puebla

Puebla City, Puebla, 72304, Mexico

Location

Related Publications (4)

• 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.

  PMID: 29146665 BACKGROUND

• 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.

  PMID: 24052337 BACKGROUND

• 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.

  PMID: 30336747 BACKGROUND

• 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.

  PMID: 31602105 BACKGROUND

Study Officials

• Francisco Javier Baez Hernández, Doctor of nursing science

  Benemerita Universidad Autonoma de Puebla

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants do not know to which group they belong. A single-blind intervention was determined
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in nursing

Model Details: The "Safe and Protected Sex" intervention program for HPV is based on Fisher and Fisher's (1993) IMB model, using social motivation to promote specific preventive actions. It raises cognitive awareness among homosexual men, enhancing their knowledge and understanding of the benefits of protective measures. The program links HPV prevention information to behavior change, incorporating key details on transmission through a horizontal methodology in nursing consultations. The teaching process builds on individuals' perceptions, knowledge, and past experiences. Through reflective learning in nursing consultations, participants make informed decisions, shaping their understanding. HPV knowledge is seen as an evolving process influenced by beliefs, attitudes, concerns, and misconceptions. The intervention fosters a dialogic awareness process, encouraging critical reflection and motivation for prevention, ultimately aiming to create a lasting impact on personal health behavios

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 10, 2025
• Study Start: December 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: June 5, 2022
• Last Updated: April 10, 2025

Record last verified: 2025-03

Locations

ME (1)