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

Completed

• Conditions: Sexual Dysfunction; Hepatitis C; HIV

• Registration Number: NCT03468673
• Lead Sponsor: University Paris 7 - Denis Diderot

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.

Study Timeline

• Study Start: 2015-02-20
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-16
• Primary Completion: 2018-12-31
• Study Completion: 2020-06-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1164

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychometric validation of a new questionnaire (PROQOL-SexLife) to assess sexual Quality of Life of people affected by HIV and HCV	4 last weeks	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.

Trial Locations

Locations (17)

Center of treatment HIV/Aids - Brazil; 🇧🇷 são Paulo, Brazil

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Hôpital de Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Hôpital Européen de Marseille; 🇫🇷 Marseille, France

CHU Nantes; 🇫🇷 Nantes, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital Necker; 🇫🇷 Paris, France

CHI Saint Germain en Laye; 🇫🇷 Saint Germain en Laye, France

Institut Mutual Montsouris; 🇫🇷 Paris, France

CH de Saint-Nazaire; 🇫🇷 Saint-Nazaire, France

CHU Purpan; 🇫🇷 Toulouse, France

Hôpital Foch; 🇫🇷 Suresnes, France

Centre Hépato -Biliaire de l'Hôpital Paul Brousse; 🇫🇷 Villejuif, France

Clinique m&dicale L'Actuel; 🇨🇦 Montréal, Quebec, Canada

Hôpital Hôtel-Dieu; 🇫🇷 Paris, France

University of Sydney; 🇦🇺 Sydney, Australia

CHU de Dijon; 🇫🇷 Dijon, France