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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03468673
Registration number
NCT03468673
Ethics application status
Date submitted
8/03/2018
Date registered
16/03/2018
Titles & IDs
Public title
International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C (PROQOL-SexLife)
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Scientific title
International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C Infections (PROQOL-SexLife)
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Secondary ID [1]
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PROunit PROQOL-SexLife ANRS
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Universal Trial Number (UTN)
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Trial acronym
SexLife
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sexual Dysfunction
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HIV
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Hepatitis C
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Psychometric validation of a new questionnaire (PROQOL-SexLife) to assess sexual Quality of Life of people affected by HIV and HCV
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Assessment method [1]
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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.
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Timepoint [1]
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4 last weeks
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* cognitive impairment or major psychiatric disorders
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/02/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2020
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Sample size
Target
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Accrual to date
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Final
1164
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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University of Sydney - Sydney
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Recruitment postcode(s) [1]
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2006 - Sydney
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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são Paulo
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Country [2]
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Canada
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State/province [2]
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Quebec
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France
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State/province [3]
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Bordeaux
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France
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State/province [4]
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Dijon
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Country [5]
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France
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State/province [5]
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Le Kremlin-Bicêtre
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Country [6]
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France
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State/province [6]
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Marseille
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Country [7]
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France
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State/province [7]
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Nantes
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Country [8]
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France
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State/province [8]
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Paris
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Country [9]
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France
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State/province [9]
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Saint Germain en Laye
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Country [10]
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France
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State/province [10]
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Saint-Nazaire
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Country [11]
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France
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State/province [11]
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Suresnes
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Country [12]
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France
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State/province [12]
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Toulouse
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Country [13]
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France
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State/province [13]
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Villejuif
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Paris 7 - Denis Diderot
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Address
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Other collaborator category [1]
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Other
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Name [1]
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University of Sydney
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Center of treatment HIV/Aids-São Paulo
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Université de Montréal
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03468673
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03468673