Clinical trial NCT01900886: Epidemiological Study to Evaluate Personality Disorders in Prison Populations in Treatment for Hepatitis C
Official title: Prospective Observational Study to Assess Personality Disorders in Prison Populations for Hepatitis C Treatment. "
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C, Chronic
Personality Disorders in Prison
Keywords: prison, disorder, hepatitis c
Lead sponsor: Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with chronic hepatitis C mono-or co-infected with HIV.

Brief summary: Primary objective: Evaluate the prevalence of personality disorders in patients starting treatment for hepatitis C in the prison and determine their influence on the evolution of the disease.

Detailed description: Secondary objectives:

* Describe the management of patients with personality disorders on treatment for hepatitis C in the prison.
* Describe the characteristics of patients who discontinue the treatment and the reasons for stratifying by the presence of personality disorders.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age.
* Patients with expected prison stay beyond the duration of follow-up period of the study.
* Patients with chronic HCV infection and detectable viral load to initiate treatment with standard therapy.
* Patients their written informed consent to participate in the study.

Exclusion Criteria:

* Patients previously treated with Interferon (IFN) and Ribavirin (RBV).
* Patients can not read or understand a written questionnaire at the discretion of the investigator.

Primary outcomes:
measure: Sustained Viral Response (SVR)
timeFrame: RNA-VHC at weeks 24 or 48
Secondary outcomes:
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: Centro Penitenciario El Puerto III
state: Cadiz
city: Albolote
country: Spain
facility: Centro Penitenciario de Albolote
state: Granada
city: Las Palmas de Gran Canaria
country: Spain
facility: Centro Penitenciario Las Palmas
state: Islas Canarias
city: Santa Cruz de Tenerife
country: Spain
facility: Centro Penitenciario de Tenerife
state: Islas Canarias
city: Ocaña
country: Spain
facility: Centro Penitenciario Ocaña I
state: Toledo
city: Almeria
country: Spain
facility: Centro Penitenciario de El Acebuche
city: Badajoz
country: Spain
facility: Centro Penitenciario de Badajoz
city: Cordoba
country: Spain
facility: Centro Penitenciario de Cordoba
city: Jaen
country: Spain
facility: Centro Penitenciario Jaen
city: Salamanca
country: Spain
facility: Centro Penitenciario de Topas
city: Sevilla
country: Spain
facility: Centro Penitenciario Sevilla I
Study officials:
affiliation: Centro Penitenciario de Hombres de Barcelona. Prisión Modelo
name: Andres Marco, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marco A, Anton JJ, Trujols J, Saiz de la Hoya P, de Juan J, Faraco I, Cayla JA; Perseo Group. Personality disorders do not affect treatment outcomes for chronic HCV infection in Spanish prisoners: the Perseo study. BMC Infect Dis. 2015 Aug 19;15:355. doi: 10.1186/s12879-015-1102-x.