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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Sexual Dysfunction; HIV

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.

• Study Type: Observational
• Enrollment (Actual): 1164

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia, 2006
    • University of Sydney
• Brazil
  • são Paulo, Brazil, 04121-000
    • Center of treatment HIV/Aids - Brazil
• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Clinique m&dicale L'Actuel
• France
  • Bordeaux, France, 33604
    • CHU de Bordeaux
  • Dijon, France, 21000
    • CHU de Dijon
  • Le Kremlin-Bicêtre, France, 94275
    • Hopital de Bicetre
  • Marseille, France, 13003
    • Hôpital Européen de Marseille
  • Nantes, France, 44093
    • CHU Nantes
  • Paris, France, 75010
    • Hôpital Lariboisière
  • Paris, France, 75004
    • Hôpital Hôtel-Dieu
  • Paris, France, 75015
    • Hopital Necker
  • Paris, France, 75014
    • Institut Mutual Montsouris
  • Saint Germain en Laye, France, 78100
    • CHI Saint Germain en Laye
  • Saint-Nazaire, France, 44600
    • CH de Saint-Nazaire
  • Suresnes, France, 92150
    • Hôpital Foch
  • Toulouse, France, 31059 cedex 9
    • Chu Purpan
  • Villejuif, France, 94804
    • Centre Hépato -Biliaire de l'Hôpital Paul Brousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 last weeks

Collaborators and Investigators

• Sponsor: University Paris 7 - Denis Diderot
• Collaborators: University of Sydney; Université de Montréal; Center of treatment HIV/Aids-São Paulo

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2015
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (ACTUAL): March 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: HCV; Questionnaire; AIDS; Psychometric validation; Qualitative analysis; Sexual Quality of Life
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: PROunit PROQOL-SexLife ANRS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No