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

NCT ID: NCT03468673

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-20
• Study Completion Date: 2020-06-30

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.

Conditions

Sexual Dysfunction; HIV; Hepatitis C

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sydney

OTHER

Sponsor Role: collaborator

Center of treatment HIV/Aids-São Paulo

UNKNOWN

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

University Paris 7 - Denis Diderot

OTHER

Sponsor Role: lead

Responsible Party

Dr Martin Duracinsky

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Sydney

Sydney, , Australia

Center of treatment HIV/Aids - Brazil

São Paulo, , Brazil

Clinique m&dicale L'Actuel

Montreal, Quebec, Canada

CHU de Bordeaux

Bordeaux, , France

CHU de Dijon

Dijon, , France

Hôpital de Bicêtre

Le Kremlin-Bicêtre, , France

Hôpital Européen de Marseille

Marseille, , France

CHU Nantes

Nantes, , France

Hôpital Hôtel-Dieu

Paris, , France

Hôpital Lariboisière

Paris, , France

Institut Mutual Montsouris

Paris, , France

Hôpital Necker

Paris, , France

CHI Saint Germain en Laye

Saint-Germain-en-Laye, , France

CH de Saint-Nazaire

Saint-Nazaire, , France

Hôpital Foch

Suresnes, , France

CHU Purpan

Toulouse, , France

Centre Hépato -Biliaire de l'Hôpital Paul Brousse

Villejuif, , France

Countries

Australia; Brazil; Canada; France

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 17332849 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17956833 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22965768 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21384286 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22846467 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15510190 (View on PubMed)

Other Identifiers

PROunit PROQOL-SexLife ANRS

Identifier Type: -

Identifier Source: org_study_id