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Sexual DysfunctionSexLifeNCT03468673

International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C (PROQOL-SexLife)

An observational study of Sexual Dysfunction and HIV, run by University Paris 7 - Denis Diderot at 17 sites in 4 countries.

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

To develop and validate a specific questionnaire of sexual quality of life in several languages and cultures (France, Brazil, Australia) allowing a meaningful and comprehensive assessment of the sexuality of patients infected with HIV and HCV; Propose reference scoring for sub-populations. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Sexual Dysfunction, HIV, Hepatitis C
How many people
1,164 participants
Where
17 sitesin 4 countries
Study dates
20 Feb 2015to 30 Jun 2020
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: People living with HIV and / or HCV and being over the age of 18, and having proficiency in English, French or Portuguese

Who may be able to join

  • People living with HIV and/or Hepatitis C
  • having proficiency in English, French or Portuguese of Brazil
  • Giving informed consent (oral or written consent according to the legislation of country)

Who cannot join

  • cognitive impairment or major psychiatric disorders

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

France14 sites

  • CHU de Bordeaux

    Bordeaux, 33604

  • CHU de Dijon

    Dijon, 21000

  • Hôpital de Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Hôpital Européen de Marseille

    Marseille, 13003

  • CHU Nantes

    Nantes, 44093

  • Hôpital Hôtel-Dieu

    Paris, 75004

  • Hôpital Lariboisière

    Paris, 75010

  • Institut Mutual Montsouris

    Paris, 75014

  • Hôpital Necker

    Paris, 75015

  • CHI Saint Germain en Laye

    Saint-Germain-en-Laye, 78100

  • CH de Saint-Nazaire

    Saint-Nazaire, 44600

  • Hôpital Foch

    Suresnes, 92150

  • CHU Purpan

    Toulouse, 31059 cedex 9

  • Centre Hépato -Biliaire de l'Hôpital Paul Brousse

    Villejuif, 94804

Other trials in France

Australia1 site

  • University of Sydney

    Sydney, 2006

Other trials in Australia

Brazil1 site

  • Center of treatment HIV/Aids - Brazil

    São Paulo, 04121-000

Other trials in Brazil

Canada1 site

  • Clinique m&dicale L'Actuel

    Montreal, Quebec

Other trials in Canada

About this study

Official title: International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C Infections (PROQOL-SexLife)

To develop and validate a specific questionnaire of sexual quality of life in several languages and cultures (France, Brazil, Australia) allowing a meaningful and comprehensive assessment of the sexuality of patients infected with HIV and HCV; Propose reference scoring for sub-populations.

Read the detailed description

Sexual health is a complex construct affecting physical, mental and social well-being. According to studies, sexual disorders are common in people with HIV infection and 25 to 71% of, both men and women regardless of their sexual orientation; and between 39 and 50 % of patients infected with Hepatitis C Virus(HCV). The cause is almost always multifactorial, with psychological, environmental and physiological components, and there may be an iatrogenic effect of treatment. HIV is a chronic disease for people with access to effective treatment. And Hepatitis C while curable is a chronic condition when untreated. In this context, sexuality is an important dimension of quality of life. But the issues are complex and not easily defined. Various studies have highlighted the lack of attention paid to sexuality in a medical management of various chronic conditions such as HIV or cancer. Indeed, a preliminary review of the literature and analysis of the concepts measured by 25 questionnaires on sexuality, shows that these instruments are inadequate to capture all aspects of the sexuality affecting quality of life of people infected with HIV or HCV. If they address physical aspects of sexuality, they address briefly at all socio-psychological and relational sexual life (body image, feeling desirable, self-esteem). Only a limited number of studies focused specifically on the experience of people suffering of sexual dysfunction in HIV and HCV infection. Moreover, these instruments do not assess specific issues related to stigma and problems related to transmission of infections of certain subgroups, particularly in the gay population.

It is an international prospective study (Australia, Brazil, Canada and France) with four phases:

Phase 1. A literature review and interview guide writing.

Phase 2. A qualitative research design based on a grounded theory research perspective:

realization and analysis of interviews with people affected by HIV and HCV, creation of the conceptual framework specific to HIV and HCV.

Phase 3. Questionnaire creation: creation of an item bank; formalization of a pilot questionnaire; forward-backward linguistic validation in each of the target languages (French, Portuguese of Brazil, English), cognitive debriefing and international harmonization; development of the conceptual model of sexual quality of life.

Phase 4. Psychometric validation of the new questionnaire: cross-sectional study by administration of the new questionnaire to 1 400 patients in the 4 countries, along with generic questionnaire about sexuality (Male sexual Health Questionnaire, Female sexual Function Index), the HIV sexual risk questionnaire, and the SF-12v2; Statistic and psychometric analysis; assessment of characteristics of different sub-populations; Propose reference scoring for sub- populations.

Impact of research: the availability of a meaningful and validated tool to detect and assess specifically sexual quality of life in HIV and HCV populations will improve the understanding of specific issues of these sub-populations. The questionnaire is intended for use in research, clinical practice, and during annual visits.

Keywords
AIDS, HCV, Questionnaire, Qualitative analysis, Sexual Quality of Life, Psychometric validation
Medical subject headings
Sexual Dysfunction, Physiological, Hepatitis C, Acquired Immunodeficiency Syndrome

What is being measured

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

  1. Psychometric validation of a new questionnaire (PROQOL-SexLife) to assess sexual Quality of Life of people affected by HIV and HCV

    PROQOL-SexLife is the developed questionnaire through qualitative analysis (phase 2 of the study). Because it is specific to these infections, it will be used to assess the sexuality of people affected by HIV and / or Hepatitis C. This questionnaire has the potential to specifically detect sexual dysfunction. It is intended for use in research, clinical practice, and during annual visits.

    Measured: 4 last weeks

Timeline

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

  1. First posted16 Mar 2018
  2. Study start20 Feb 2015
  3. Primary completion31 Dec 2018
  4. Study completion30 Jun 2020

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
Other
Time perspective
Prospective
Enrolment
1,164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03468673
Sponsor's protocol ID
PROunit PROQOL-SexLife ANRS
Acronym
SexLife
Status last verified
Apr 2021
First submitted
8 Mar 2018
Last updated
27 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • WHO | Sexual health [Internet]. WHO. Available from: http://www.who.int/topics/sexual_health/en/

  • Koole O, Noestlinger C, Colebunders R. Quality of life in HIV clinical trials: why sexual health must not be ignored. PLoS Clin Trials. 2007 Mar 2;2(3):e8. doi: 10.1371/journal.pctr.0020008. No abstract available.

    PubMed 17332849

  • Marcellin F, Preau M, Ravaux I, Dellamonica P, Spire B, Carrieri MP. Self-reported fatigue and depressive symptoms as main indicators of the quality of life (QOL) of patients living with HIV and Hepatitis C: implications for clinical management and future research. HIV Clin Trials. 2007 Sep-Oct;8(5):320-7. doi: 10.1310/hct0805-320.

    PubMed 17956833

  • Sandfort TG, Collier KL, Grossberg R. Addressing sexual problems in HIV primary care: experiences from patients. Arch Sex Behav. 2013 Oct;42(7):1357-68. doi: 10.1007/s10508-012-0009-5. Epub 2012 Sep 11.

    PubMed 22965768

  • Meystre-Agustoni G, Jeannin A, de Heller K, Pecoud A, Bodenmann P, Dubois-Arber F. Talking about sexuality with the physician: are patients receiving what they wish? Swiss Med Wkly. 2011 Mar 8;141:w13178. doi: 10.4414/smw.2011.13178. eCollection 2011.

    PubMed 21384286

  • Dyer K, das Nair R. Why don't healthcare professionals talk about sex? A systematic review of recent qualitative studies conducted in the United kingdom. J Sex Med. 2013 Nov;10(11):2658-70. doi: 10.1111/j.1743-6109.2012.02856.x. Epub 2012 Jul 30.

    PubMed 22846467

  • Soykan A, Boztas H, Idilman R, Ozel ET, Tuzun AE, Ozden A, Ozden A, Kumbasar H. Sexual dysfunctions in HCV patients and its correlations with psychological and biological variables. Int J Impot Res. 2005 Mar-Apr;17(2):175-9. doi: 10.1038/sj.ijir.3901267.

    PubMed 15510190

  • Etemadi F, Bessonneau P, Yaya I, Dara A, Eriksson L, Rodriguez S, Lona Juraskova, Henrique M, Rejean T, Griffith W, Thonon F, Chassany O, Duracinsky M. Factors associated with sexual quality of life among men living with HIV. Int J STD AIDS. 2024 Apr;35(5):352-364. doi: 10.1177/09564624231217324. Epub 2023 Dec 26.

    PubMed 38146622

Questions about this trial

What is this clinical trial studying?

An observational study of Sexual Dysfunction and HIV, run by University Paris 7 - Denis Diderot at 17 sites in 4 countries.

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 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France, Australia, Brazil, Canada. 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?

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?

Psychometric validation of a new questionnaire (PROQOL-SexLife) to assess sexual Quality of Life of people affected by HIV and HCV (time frame: 4 last weeks). 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 NCT03468673, which also lists 8 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 27 Apr 2021.

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