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767576

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, with reference to the NHS and Public Health England HIV PrEP impact trial, what steps his Department is taking to ensure that the revised start date for the trial is not missed.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106653
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106543 106651 106652 106654 106655 question first answered 17/10/2017 16:48:49 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson

767579

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, with reference to the NHS and Public Health England HIV PrEP impact trial, what steps his Department has taken to ensure that some trial places are reserved for under-represented groups.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106652
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106543 106651 106653 106654 106655 question first answered 17/10/2017 16:48:48 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson

767578

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, with reference to the NHS and Public Health England HIV PrEP impact trial, what steps he is taking to ensure that people in areas that are not included in that trial can access this treatment.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106651
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106543 106652 106653 106654 106655 question first answered 17/10/2017 16:48:48 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson

767577

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, with reference to the NHS and Public Health England HIV PrEP impact trial, what assessment he has made of the reasons why the target trial start date of September 2017 was not met.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106654
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106543 106651 106652 106653 106655 question first answered 17/10/2017 16:48:49 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson

767536

	registered interest
	date	09/10/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	HIV Infection: Clinical Trials
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, what recent assessment he has made of the potential of pre-exposure prophylaxis for HIV to help end the transmission of HIV among at-risk populations.
	tabling member constituency	Washington and Sunderland West
	tabling member printed	Mrs Sharon Hodgson
	uin	106543
	answer	answer is ministerial correction date of answer 17/10/2017 answer text <p>NHS England will enrol 10,000 participants over three years at clinics across the country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide data on implementation of PrEP and its impact on HIV transmission among high-risk groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial will be assessed against inclusion and exclusion criteria in order to target those at high risk of getting HIV and therefore most likely to benefit. National Health Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p> </p><p>NHS England and Public Health England have been actively supporting the PrEP IMPACT trial sponsor in accelerating ethical approval and trial site recruitment. It was not possible to complete all the necessary steps to achieve a September 2017 start because of the large number of trial sites. Trial sites have to assure the trial co-ordination centre has ethical approval, drug procurement, trial site feasibility assessments, trial site training, local commissioner approval and local research governance approval in place before permission to recruit is given. This is dependent on local processes and is variable. Trial opening dates will be staggered to reflect this.</p><p> </p><p>The first clinics began be enrolling patients in October and a number of clinics will be opening within weeks of each other, both in and outside London. The trial sponsor anticipates that up to 70 sites will be enrolling patients by the end of November. All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest single study of its type in the world, the PrEP trial is complex, involving well in excess of 100 organisations ranging from sexual health clinics, local authority commissioners, research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across the country can provide geographical access and avoid surges to individual clinics. As trial sites open, information will be uploaded to the trial website enabling individuals who wish to participate in the trial to identify their nearest local clinic.</p><p> </p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for groups at high HIV risk other than gay men. The trial co-ordinating team will monitor PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 106651 106652 106653 106654 106655 question first answered 17/10/2017 16:48:48 answering member 4067 label Biography information for Steve Brine
	tabling member	1521 label Biography information for Mrs Sharon Hodgson