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

Sponsor

University Paris 7 - Denis Diderot (Other)

Overall Status

Completed

CT.gov ID

NCT03468673

Collaborator

University of Sydney (Other), Center of treatment HIV/Aids-São Paulo (Other), Université de Montréal (Other)

1,164

Enrollment

Locations

64.3

Actual Duration (Months)

68.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction HIV Hepatitis C

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 Design

Study Type:

Observational

Actual Enrollment :

1164 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 20, 2015

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Jun 30, 2020

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Sydney	Sydney		Australia	2006
2	Center of treatment HIV/Aids - Brazil	são Paulo		Brazil	04121-000
3	Clinique m&dicale L'Actuel	Montréal	Quebec	Canada
4	CHU de Bordeaux	Bordeaux		France	33604
5	CHU de Dijon	Dijon		France	21000
6	Hôpital de Bicêtre	Le Kremlin-Bicêtre		France	94275
7	Hôpital Européen de Marseille	Marseille		France	13003
8	CHU Nantes	Nantes		France	44093
9	Hôpital Hôtel-Dieu	Paris		France	75004
10	Hôpital Lariboisière	Paris		France	75010
11	Institut Mutual Montsouris	Paris		France	75014
12	Hôpital Necker	Paris		France	75015
13	CHI Saint Germain en Laye	Saint Germain en Laye		France	78100
14	CH de Saint-Nazaire	Saint-Nazaire		France	44600
15	Hôpital Foch	Suresnes		France	92150
16	CHU Purpan	Toulouse		France	31059 cedex 9
17	Centre Hépato -Biliaire de l'Hôpital Paul Brousse	Villejuif		France	94804