PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation
HIV pre-exposure prophylaxis (PrEP) is the use of anti-HIV medicines by HIV negative people in order to prevent them from becoming HIV positive if exposed to HIV.
Currently, the combination drug containing tenofovir and emtricitabine is licensed in Europe for use as HIV PrEP. We know from previous studies worldwide that this combination drug is very good at reducing the risk of HIV infection and several countries have implemented PrEP programmes to provide PrEP to individuals at high risk of HIV.
However, it is difficult to effectively plan for a national PrEP programme in England without knowing how many people will need PrEP, how many will want to take PrEP, and how long they will stay on PrEP.
In order to find this out, the PrEP Impact Trial will make PrEP available to at least 10,000 people over three years. HIV negative men and women attending sexual health clinics in England will have their risk of HIV assessed by their care team and be offered PrEP if they meet the eligibility criteria. Through the trial we will be able to measure how many attendees at sexual health clinics meet eligibility criteria for PrEP, how many of these take up the offer of PrEP and how long they remain on PrEP for.
There will not be any additional tests other than those recommended for the safe delivery of PrEP. These include tests for sexually transmitted infections (STIs) and HIV as well as urine and blood tests to monitor kidney function. Information about attendances and test results will be anonymously collected through the existing data reporting system that sexual health clinics currently use to report to Public Health England.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hannah Reaney
- Número de teléfono: 07887476175
- Correo electrónico: impact@ststcr.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The participant populations for this trial will be men and women attending GUM clinics who belong to one of three populations recognised to be at high risk for HIV, namely:
A. Men (cisgender and transgender) and transgender women who:
- Have sex with men
- Have had an HIV negative test during an earlier episode of care in the preceding year
- Report condomless intercourse in the previous 3 months
- Affirm their likelihood of having condomless intercourse in the next 3 months
B. HIV negative partners of an HIV positive person when:
- The HIV positive partner is not known to be virally suppressed (<200 copies/ml for 6 months or more)
- Condomless intercourse is anticipated before treatment of the HIV positive partner takes effect
C.HIV negative persons who:
1. Are clinically assessed and considered to be at similar high risk of HIV acquisition as those with a serodiscordant partner who is not known to be virally suppressed
Descripción
Inclusion Criteria:
The participant populations for this trial will be men and women attending GUM clinics who belong to one of three populations recognised to be at high risk for HIV, namely:
A. Men (cisgender and transgender) and transgender women who:
- Have sex with men
- Have had an HIV negative test during an earlier episode of care in the preceding year
- Report condomless intercourse in the previous 3 months
- Affirm their likelihood of having condomless intercourse in the next 3 months
B. HIV negative partners of an HIV positive person when:
- The HIV positive partner is not known to be virally suppressed (<200 copies/ml for 6 months or more)
- Condomless intercourse is anticipated before treatment of the HIV positive partner takes effect
C.HIV negative persons who:
1. Are clinically assessed and considered to be at similar high risk of HIV acquisition as those with a serodiscordant partner who is not known to be virally suppressed
Participants will therefore be considered eligible for trial enrolment if they fulfil all the following individual eligibility criteria:
- Belongs to one of the three at high HIV risk populations described above
- Aged 16 years or over (no upper limit)
- Considered to be HIV negative on the day of enrolment
- Willing and able to provide informed consent
- Willing to adhere to the recommended PrEP regimen
- Willing to re-attend the trial clinic at appropriate intervals for risk assessment
Exclusion Criteria:
- An acute viral illness that could be due to HIV seroconversion
- Any contraindication to Tenofovir Disoproxil (TD)/ Emtricitabine (FTC)-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PrEP Eligibility
Periodo de tiempo: 3 years
|
The proportion of GUM clinic attendees meeting the eligibility criteria for PrEP
|
3 years
|
|
PrEP Eligibility (duration)
Periodo de tiempo: 3 years
|
The duration for which GUM clinic attendees are eligible for PreP
|
3 years
|
|
PrEP Uptake
Periodo de tiempo: 3 years
|
The proportion of PrEP eligible GUM clinic attendees prescribed PrEP
|
3 years
|
|
PrEP Uptake (duration)
Periodo de tiempo: 3 years
|
The duration for which eligible GUM clinic attendees use PrEP
|
3 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
HIV
Periodo de tiempo: 3 years
|
HIV diagnoses reported by sites and identified through the national surveillance dataset
|
3 years
|
|
STIs
Periodo de tiempo: 3 years
|
STI diagnoses (gonorrhoea, chlamydia, syphilis and hepatitis C) reported in the national surveillance dataset
|
3 years
|
|
Adverse Events
Periodo de tiempo: 3 years
|
|
3 years
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
Otros números de identificación del estudio
- SSCR104
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Infecciones por VIH
-
Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
-
Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
-
China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán