Clinical trial NCT03468673: International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C (PROQOL-SexLife)
Official title: International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C Infections (PROQOL-SexLife)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction
HIV
Hepatitis C
Keywords: AIDS
HCV
Questionnaire
Qualitative analysis
Sexual Quality of Life
Psychometric validation
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: Center of treatment HIV/Aids-São Paulo
name: Université de Montréal
First posted: 2018-03-16
Enrollment: 1164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living with HIV and / or HCV and being over the age of 18, and having proficiency in English, French or Portuguese

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* cognitive impairment or major psychiatric disorders

Primary outcomes:
measure: Psychometric validation of a new questionnaire (PROQOL-SexLife) to assess sexual Quality of Life of people affected by HIV and HCV
timeFrame: 4 last weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of Sydney
city: são Paulo
country: Brazil
facility: Center of treatment HIV/Aids - Brazil
city: Montréal
country: Canada
facility: Clinique m&dicale L'Actuel
state: Quebec
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Dijon
country: France
facility: CHU de Dijon
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital de Bicêtre
city: Marseille
country: France
facility: Hôpital Européen de Marseille
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hôpital Hôtel-Dieu
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Institut Mutual Montsouris
city: Paris
country: France
facility: Hôpital Necker
city: Saint Germain en Laye
country: France
facility: CHI Saint Germain en Laye
city: Saint-Nazaire
country: France
facility: CH de Saint-Nazaire
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: CHU Purpan
city: Villejuif
country: France
facility: Centre Hépato -Biliaire de l'Hôpital Paul Brousse
Study officials:
References:
citation: WHO | Sexual health [Internet]. WHO. Available from: http://www.who.int/topics/sexual_health/en/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.