International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C (PROQOL-SexLife)
SexLife
1 other identifier
observational
1,164
4 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2015
CompletedFirst Submitted
Initial submission to the registry
March 8, 2018
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedApril 27, 2021
April 1, 2021
3.9 years
March 8, 2018
April 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
People living with HIV and / or HCV and being over the age of 18, and having proficiency in English, French or Portuguese
You may qualify if:
- 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)
You may not qualify if:
- cognitive impairment or major psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Paris 7 - Denis Diderotlead
- University of Sydneycollaborator
- Center of treatment HIV/Aids-São Paulocollaborator
- Université de Montréalcollaborator
Study Sites (17)
University of Sydney
Sydney, 2006, Australia
Center of treatment HIV/Aids - Brazil
São Paulo, 04121-000, Brazil
Clinique m&dicale L'Actuel
Montreal, Quebec, Canada
CHU de Bordeaux
Bordeaux, 33604, France
CHU de Dijon
Dijon, 21000, France
Hôpital de Bicêtre
Le Kremlin-Bicêtre, 94275, France
Hôpital Européen de Marseille
Marseille, 13003, France
CHU Nantes
Nantes, 44093, France
Hôpital Hôtel-Dieu
Paris, 75004, France
Hôpital Lariboisière
Paris, 75010, France
Institut Mutual Montsouris
Paris, 75014, France
Hôpital Necker
Paris, 75015, France
CHI Saint Germain en Laye
Saint-Germain-en-Laye, 78100, France
CH de Saint-Nazaire
Saint-Nazaire, 44600, France
Hôpital Foch
Suresnes, 92150, France
CHU Purpan
Toulouse, 31059 cedex 9, France
Centre Hépato -Biliaire de l'Hôpital Paul Brousse
Villejuif, 94804, France
Related Publications (7)
WHO | Sexual health [Internet]. WHO. Available from: http://www.who.int/topics/sexual_health/en/
BACKGROUNDKoole 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.
PMID: 17332849BACKGROUNDMarcellin 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.
PMID: 17956833BACKGROUNDSandfort 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.
PMID: 22965768BACKGROUNDMeystre-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.
PMID: 21384286BACKGROUNDDyer 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.
PMID: 22846467BACKGROUNDSoykan 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.
PMID: 15510190BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
March 8, 2018
First Posted
March 16, 2018
Study Start
February 20, 2015
Primary Completion
December 31, 2018
Study Completion
June 30, 2020
Last Updated
April 27, 2021
Record last verified: 2021-04