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Human Papillomavirus InfectionHPVandFSFINCT03837028

The Human Papilloma Virus Effect on Sexual Life

An observational study of Human Papillomavirus Infection, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).

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

Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases and its link with malignancies is well established, especially with anogenital tract cancers (cervical, vaginal, vulvar, anal cancers). Read more about this study

Who is it for?
Ages 30 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Human Papillomavirus Infection
What is being tested?
FSFI
How many people
127 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2018to 1 Oct 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 30 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Women who were attended to our gynecology outpatient clinic due to HPV positivity according to the cervical cancer screening programme were recruited in this study.

Who may be able to join

  • women aged between 30 and 50 years
  • sexually active women
  • women who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82)

Who cannot join

  • postmenopausal women (defined as those with at least 12 consecutive months of amenorrhea with no other medical cause and a follicle- stimulating hormone (FSH) level of 40)
  • women with chronic disease
  • patients with antidepressant usage or patients with psychiatric disorders
  • women who did not agree to participate in the study after reading the informed consent form
  • women who admitted for follow up due to prior HPV infection
  • women with only low-risk HPV (HPV 6, 11) positivity
  • women with a sexual abuse history
  • women with sexual penetration disorder

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bakirkoy Dr. Sadi Konuk Training and Research Hospital

    Istanbul, 34147

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Human Papilloma Virus Genotype on Women's Sexual Life

Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases and its link with malignancies is well established, especially with anogenital tract cancers (cervical, vaginal, vulvar, anal cancers). HPV 16 and 18 are the most commonly isolated HPV types in cervical cancer, however not all infections with HPV 16 or 18 progress to cancer. After the HPV test has been used in cervical cancer screening, there have been concerns about whether women carry this virus. Although HPV testing may cause negative emotional responses, adverse emotional responses are related to HPV infection rather than testing. In this respect, there were several studies which evaluated the quality of life and psychological responses of women with positive HPV test results and it is known that positive HPV test results cause additional anxiety, distress and negative emotional responses in women. We hypothesized that the awareness of having a sexually transmitted infection in women with HPV and, therefore, a close follow-up and the need for further investigation such as colposcopy can affect their sexual life. In this study, we aimed to observe the changes in sexual function and anxiety of the HPV positive women with validated objective tools after being informed about their co-test results.

Read the detailed description

The present prospective, observational study was undertaken among women who were attended to our gynecology outpatient clinic due to HPV positivity according to the cervical cancer screening programme. After the ethics approval was obtained from our hospital's local ethics committee, women aged between 30 and 50 years, sexually active, and who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82) were included in the study. Women with HPV positive were given standard information about HPV and HPV testing (co-test) developed by a clinical expert. This information includes; sexually transmitted nature of HPV, its high prevalence in sexually active women, usually transient nature of HPV, the association between high risk and low- risk HPV types and cervical intraepithelial neoplasia (CIN) and cervical cancer, the importance of HPV 16/18 positivity for cervical premalignant and malign lesions. After given the standard information, the patients were informed about their co-test results including HPV genotype, cytology results. The demographic data of the patients such as gravidity, parity,Body Mass Index (BMI), educational status, and marital status were recorded at the time of admission. The routine gynecologic examination was performed to all participants. The BMI was calculated as weight (kg) divided by the square of the height (m2). The patients were divided into four groups according to their HPV genotype and cytology results. The patients were divided into four groups according to their HPV genotype and cytology results. Group 1: HPV 16/18 (+), cytology normal, Group 2: HPV 16/18 (+), cytology abnormal, Group 3: non-16/18 HPV (+), cytology abnormal, Group 4: non-16/18 HPV (+), cytology normal. In our clinic, we manage the patients with abnormal co-test results according to the American Society for Colposcopy and Cervical Pathology guidelines. The patients in group 1, 2, and 3 were referred to colposcopy according to American Society for Colposcopy and Cervical Pathology (ASCCP) guideline and the patients in group 4 were referred to colposcopy according to their symptoms and vaginal examination results such as suspicious cervical observation for cervical intraepithelial neoplasia, postcoital bleeding and all of the participants were informed about the colposcopy procedure. All of the patients called for a follow-up visit two months later and were performed a colposcopy. Sexual function of the patients was assessed at the time of admission and two months later via the self-administered Female Sexual Function Index (FSFI) questionnaire. The anxiety status of the patients has assessed via the Beck Anxiety Inventory (BAI) questionnaire at the time of admission and 2 months later.

Cervical Cancer Screening and management of the results:

According to the national cervical cancer screening program in our country, screening is initiating at the age of 21 and women age <30 are screening with Papanicolaou test alone at intervals of every three years. Women ≥ 30 years have been screening with co-testing (HPV testing and Pap test) every five years. When HPV positivity is detected in the co-test, the HPV genotype is determined and the pap test is evaluated cytologically. While the patients with HPV 16/18 positive (cytology normal or abnormal) and non-HPV 16/18 positive and cytology abnormal referred to a specialist gynecologist for colposcopy, it is recommended that patients who have a non-HPV 16/18 positive and cytology normal should have a co-test after 1 year.

Beck Anxiety Inventory The Beck Anxiety Inventor (BAI) is a brief measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. The BAI is administered via self-report and includes assessment of symptoms such as nervousness, dizziness, inability to relax, etc. The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The BAI is used in efforts to obtain a purer measure of anxiety that is relatively independent of depression. The total score is calculated by finding the sum of the 21 items. It is defined as; Score of 0-21 = low anxiety Score of 22-35 = moderate anxiety Score of 36 and above = potentially concerning levels of anxiety Female Sexual Function Index Sexual dysfunction was assessed via the self-administered FSFI which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire (two questions); arousal and lubrication (four questions each); and orgasm, satisfaction, and pain (three questions each). The possible scores are 0-5 for the arousal, lubrication, orgasm, and pain domains; 1-5 for the satisfaction domain; and 1-5 for the desire domain. Domain scores were obtained by summing the scores of the individual items comprising the domain and then multiplying by the following domain factors: 0.6 for desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain. Regarding the individual domains, a score of less than 65% of the maximum achievable score was considered to indicate dysfunction in that domain. Thus, a score of less than 3.9 in each domain was considered to indicate Female sexual disorder (FSD). The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The total FSFI score was calculated and categorized as a dichotomous variable using 26.55 as a cutoff for overall Female sexual disorder. Sexual function was further categorized into four groups, as described previously: normal sexual function (total FSFI score ≥26.55), mild Female sexual disorder (total FSFI score 18-26.55), moderate Female sexual disorder (total FSFI score 11-17), and severe Female sexual disorder (total FSFI score ≤10).

We compared the FSFI and BAI scores between the groups and between the time of admission and 2 months later.

Being tested
FSFI
Medical subject headings
Papillomavirus Infections

What participants receive

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

  • FSFIOther

    Also called Female Sexual Function Index Questionnaire

    Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.

Study groups in NCT03837028
Study groupRoleWhat they receive
HPV 16/18 (+), cytology normalWomen who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
Receives: Other: FSFI
HPV 16/18 (+), cytology abnormalWomen who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
Receives: Other: FSFI
non-16/18 HPV (+), cytology abnormalWomen who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
Receives: Other: FSFI
non-16/18 HPV (+), cytology normalWomen who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
Receives: Other: FSFI

What is being measured

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

  1. Female Sexual Function Index (FSFI) Score

    This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and six domain scores are our first primer outcomes.

    Measured: change from initial overall FSFI score at second months.

Secondary outcomes (1)
  1. Beck Anxiety Inventory (BAI) Score

    The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score is calculated by finding the sum of the 21 items. The BAI scores range from 0 to 63 and higher scores are associated with high anxiety levels.

    Measured: change from initial BAI score at second months.

Timeline

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

  1. First posted11 Feb 2019
  2. Study start1 Jan 2018
  3. Primary completion1 Jun 2018
  4. Study completion1 Oct 2018

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03837028
Sponsor's protocol ID
BakirkoyDr.SadiKonuk
Acronym
HPVandFSFI
Status last verified
Sep 2020
First submitted
8 Feb 2019
Last updated
6 Oct 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The researchers in the study have not yet taken a decision on individual participant data (IPD) sharing.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Papillomavirus Infection, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).

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 3 inclusion and 8 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 6 Oct 2020. 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 Turkey (Türkiye). 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. 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?

Yes. Results are posted in the registry (first posted 1 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Female Sexual Function Index (FSFI) Score (time frame: change from initial overall FSFI score at second months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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