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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03468673




Registration number
NCT03468673
Ethics application status
Date submitted
8/03/2018
Date registered
15/03/2018
Date last updated
20/03/2018

Titles & IDs
Public title
International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C (PROQOL-SexLife)
Scientific title
International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C Infections (PROQOL-SexLife)
Secondary ID [1] 0 0
PROunit PROQOL-SexLife ANRS
Universal Trial Number (UTN)
Trial acronym
SexLife
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual Dysfunction 0 0
HIV 0 0
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
4 last weeks

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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- cognitive impairment or major psychiatric disorders

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
são Paulo
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
France
State/province [3] 0 0
Bordeaux
Country [4] 0 0
France
State/province [4] 0 0
Dijon
Country [5] 0 0
France
State/province [5] 0 0
Le Kremlin-Bicêtre
Country [6] 0 0
France
State/province [6] 0 0
Marseille
Country [7] 0 0
France
State/province [7] 0 0
Nantes
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Saint Germain en Laye
Country [10] 0 0
France
State/province [10] 0 0
Saint-Nazaire
Country [11] 0 0
France
State/province [11] 0 0
Suresnes
Country [12] 0 0
France
State/province [12] 0 0
Toulouse
Country [13] 0 0
France
State/province [13] 0 0
Villejuif

Funding & Sponsors
Primary sponsor type
Other
Name
University Paris 7 - Denis Diderot
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Center of treatment HIV/Aids-São Paulo
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Université de Montréal
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03468673
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.
Marcellin F, Préau 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.
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, Pécoud 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. Review.
Soykan A, Boztas H, Idilman R, Ozel ET, Tüzün 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Martin Duracinsky, MD
Address 0 0
Country 0 0
Phone 0 0
140275748
Fax 0 0
Email 0 0
duracinsky.m@gmail.fr
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable