Human Papilloma Virus Awareness Intervention

NCT ID: NCT06920589

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-06-05

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Human Papilloma Virus (HPV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The participants do not know to which group they belong. A single-blind intervention was determined

Study Groups

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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

Group Type EXPERIMENTAL

Safe and Protected Sex" intervention targeting HPV

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Diptych of the Secretary of Health in Mexico

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Francisco Javier Báez Hernández

UNKNOWN

Sponsor Role collaborator

Hospital Univeristario Benemerita Universidad Autonoma de Puebla

OTHER

Sponsor Role lead

Responsible Party

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Jorge Alberto Mayo Abarca

Master in nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Javier Baez Hernández, Doctor of nursing science

Role: STUDY_DIRECTOR

Benemerita Universidad Autonoma de Puebla

Locations

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School of Nursing Benemérita Universidad Autonoma de Puebla

Puebla City, Puebla, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 29146665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24052337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30336747 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31602105 (View on PubMed)

Other Identifiers

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SIEP/ME/112/2021

Identifier Type: -

Identifier Source: org_study_id

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