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Human Papilloma Virus (HPV)NCT06920589

Human Papilloma Virus Awareness Intervention

A study testing Safe and Protected Sex" intervention targeting HPV and Diptych of the Secretary of Health in Mexico in people with Human Papilloma Virus (HPV), run by Hospital Univeristario Benemerita Universidad Autonoma de Puebla at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, men onlyHealthy volunteers can take part
Conditions the study is for
Human Papilloma Virus (HPV)
What is being tested?
Safe and Protected Sex" intervention targeting HPV and Diptych of the Secretary of Health in Mexico
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteMexico
Study dates
1 Dec 2021to 5 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • School of Nursing Benemérita Universidad Autonoma de Puebla

    Puebla City, Puebla, 72304

Other trials in Mexico

About this study

Official title: 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.

Read the 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).

Being tested
Safe and Protected Sex" intervention targeting HPV, Diptych of the Secretary of Health in Mexico
Keywords
intervention, Knowledge, Homosexual me

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Safe and Protected Sex" intervention targeting HPVBehavioural

    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.

  • Diptych of the Secretary of Health in MexicoBehavioural

    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.

Study groups in NCT06920589
Study groupRoleWhat they receive
Safe and protected sex intervention groupExperimentalThis 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
Receives: Behavioral: Safe and Protected Sex" intervention targeting HPV
Placebo control groupPlacebo comparatorFor 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.
Receives: Behavioral: Diptych of the Secretary of Health in Mexico

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 month

Secondary outcomes (2)

  1. 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

    Measured: 1 month

  2. 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2025
  2. Study start1 Dec 2021
  3. Primary completion31 Jan 2022
  4. Study completion5 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06920589
Sponsor's protocol ID
SIEP/ME/112/2021
Status last verified
Mar 2025
First submitted
13 Mar 2025
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The study continues in a phase of improvement and replication in different contexts to improve its generalization.

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.

    PubMed 29146665

  • 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.

    PubMed 24052337

  • 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.

    PubMed 30336747

  • 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.

    PubMed 31602105

Questions about this trial

What is this clinical trial studying?

A study testing Safe and Protected Sex" intervention targeting HPV and Diptych of the Secretary of Health in Mexico in people with Human Papilloma Virus (HPV), run by Hospital Univeristario Benemerita Universidad Autonoma de Puebla at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge of human papillomavirus (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06920589, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.

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