Linkage of NHS Digital data to young people with perinatal HIV, to monitor cancers and deaths.

There is a substantial knowledge gap about health outcomes of children living with perinatal human immunodeficiency virus (PHIV) worldwide. In 2019 an estimated 1.8 million children and young people (aged 13-24) were living with HIV globally, and even with scale-up of interventions to reduce vertical HIV transmission (When a young person acquires HIV in utero or during birth), there remained an estimated 150,000 new infections among infants in that year alone. The treatment for HIV is called antiretroviral therapy (ART). ART involves taking a combination of HIV medicines (called an HIV treatment regimen) every day. With improved access to ART, a growing number of perinatally infected children and young people will be reaching adolescence and young adulthood over the next two decades.

The UK has some of the first generation of paediatric HIV survivors and a unique opportunity to inform global knowledge on their long-term health outcomes as they enter early adulthood, underpinned by a reasonable sized, virtually complete national paediatric cohort and strong links with adult HIV clinics. No other country in Europe, or indeed globally, has such an integrated paediatric network with high patient ascertainment (and thus less selection bias), high quality data, and professionals and young people working side by side to maximise health outcomes, combined with the ability to track these participants into adulthood. At present very little is known about the risk of cancers and death in adulthood in young people living with perinatal HIV. This group’s risk of cancer may be higher than the general population due to ongoing inflammation from HIV, and long-term exposure to antiretroviral agents. They may also be at risk of higher mortality from a variety of causes.

Studies have shown that health outcomes for chronic conditions are worse in adolescents than in both children and adults, and that poorly-planned transition of care is linked to deteriorating health outcomes. The term 'transition' refers to when children move from being cared for in paediatric services to adolescent/adult clinics.

The importance of transition in young people with PHIV has been acknowledged in many editorials, and paediatric HIV management has been the subject of considerable research. Yet very few studies with comprehensive coverage of the population, minimising selection bias, have addressed the question of health outcomes after transition. There are lots of studies that tell us about cancers and mortality in adults with HIV and data suggests life expectancy is quite similar to the general population, but there are no data on young people with PHIV and their long-term risks of cancers and death. There is therefore a major gap in the global understanding of what these young people can expect as they reach adulthood.

BACKGROUND - The Collaborative HIV Paediatric Study (CHIPS) and the Overarching study, the National Surveillance of HIV in Pregnancy and Childhood (NSHPC);

Since 1989 and across the UK and Ireland, the National Surveillance of HIV in Pregnancy and Childhood (NSHPC), (now known as The Integrated Screening Outcomes Surveillance Service (ISOSS)), has collected data on children with HIV visiting treatment services for the first time, and infants born to women living with HIV. ISOSS is based at the Great Ormond Street Institute of Child Health at UCL. Data are sent from hospitals to ISOSS via pregnancy and child health routine reporting systems, and include demographics (e.g. sex and age) and HIV test results.

CHIPS was established in 2000, and it complemented the NSHPC by collecting follow-up data on children living with HIV. The NSHPC let CHIPS know of any new children with confirmed HIV infection, and CHIPS would then send out annual data collection forms to the clinic caring for the child. Children were followed in CHIPS until they transferred to adult care.

The overall aim of CHIPS is to monitor the health of children with HIV, and help the NHS by checking that clinics are providing the best possible care to children with HIV. CHIPS expanded over the years, and as of July 2020 there were 35 clinics participating in the study. All clinics caring for children living with HIV reported their patients to CHIPS. The Republic of Ireland stopped contributing data to CHIPS in 2018.

Children and their families were not asked to provide consent to participate in CHIPS, as CHIPS is the national surveillance study for children with HIV, and has specific approvals to collect data without consent.

The data collected in CHIPS are used for a range of analyses. An annual report and PowerPoint slides are available on the CHIPS website (www.chipscohort.ac.uk), and give an overview of the data. A range of aspects of paediatric HIV have been investigated, including characteristics of the whole cohort,(1) clinical outcomes at the point of transition to adult care (2) and after transition,(3) as well as response to antiretroviral therapy.(4, 5)

CHIPS is funded by the NHS (London Specialised Commissioning Group) and has received additional support from Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Gilead Sciences, Janssen and Roche. These funders have no influence over, or involvement with CHIPS +.

The main CHIPS study closed on March 31st 2021. Due to the recent changes at PHE, (now UKHSA), NHS England had now become the new data controller for surveillance for children that are seen in paediatric care until they transition to adult care, which is now called the Children’s HIV and AIDS Reporting System (CHARS) and replaces CHIPS+ completely. Data collection for this new study is conducted by ISOSS at ICH, UCL.

REFERENCES

1. Judd A, Doerholt K, Tookey PA, Sharland M, Riordan A, Menson E, et al. Morbidity, mortality, and response to treatment by children in the United Kingdom and Ireland with perinatally acquired HIV infection during 1996-2006: planning for teenage and adult care. Clin Infect Dis. 2007;45(7):918-24.

2. Collins IJ, Foster C, Tostevin A, Tookey P, Riordan A, Dunn D, et al. Clinical status of adolescents with perinatal HIV at transfer to adult care in the UK/Ireland. Clin Infect Dis. 2017;64(8):1105-12.

3. Judd A, Collins IJ, Parrott F, Hill T, Jose S, Ford D, et al. Growing up with perinatal HIV: changes in clinical outcomes before and after transfer to adult care in the UK. J Int AIDS Soc. 2017;20(Suppl 3):71-80.

4. Childs T, Shingadia D, Goodall R, Doerholt K, Lyall H, Duong T, et al. Outcomes after viral load rebound on first-line antiretroviral therapy in HIV-infected children in the UK/Ireland: an observational cohort study. The Lancet HIV. 2015;2(4):e151-e8.

5. Chappell E, Lyall H, Riordan A, Thorne C, Foster C, Butler K, et al. The cascade of care for children and adolescents with HIV in the UK and Ireland, 2010 to 2016. J Int AIDS Soc. 2019;22(9):e25379.

THIS STUDY - Collaborative HIV Paediatric Study (CHIPS)+:

This study aims to provide evidence on health outcomes in early adulthood and will provide the foundation for long-term monitoring. The Collaborative HIV Paediatric Study (CHIPS)+ cohort includes young people (aged 15 years and upwards) from the original CHIPS, a national cohort study of children living with HIV in the UK and is one of the best established cohorts of young people with PHIV in the world. Within this cohort the study team have estimated the risks of cancers and deaths in paediatric care. However, there are no comprehensive estimates of incidence of cancers and deaths in adult care, hence the study team's request to link NHS Digital data to the cohort of CHIPS+ participants (approximately 750 individuals).

The main aim of the CHIPS+ study is to evaluate the short and medium-term health outcomes of young people with PHIV following transition to adult care, by clinic type, and to establish a mechanism to follow this group in the future.

The objectives of the CHIPS+ study is:

1. To consent young people with PHIV aged 15 years and over into a new perinatal HIV adult cohort for CHIPS+ and create a dataset containing life course (paediatric and adult) disease and treatment history

2. To estimate prevalence/incidence of engagement in care and key health outcomes pre- and 1-5 years post-transition, overall and by clinic type

The study requests the linkage to NHS Digital's Demographics, Cancer Registrations, and Civil Registration (Deaths) data sets, to obtain routinely collected data of the CHIPS+ cohort for long-term health outcomes, and to estimate the incidence of cancers and deaths.

***** ADDED TO VERSION 1***** In order to estimate incidence of cancers the CHIPS+ Study team have to include the sensitive cancer_anniversary fields as without this field it is not known when in the patient’s lifetime these cancers occurred. The identifiable Cancer registration number field is also required in case the team want to follow up further details of the cancer with the National Cancer Registration and Analysis Service (NCRAS).

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This study will provide evidence on health outcomes in early adulthood and will provide the foundation for long term monitoring. The linkage to NHS Digital record-level data, for cancer and mortality data will be critical to estimate the risk of disease progression, hospitalisation and mortality and will help to tailor future HIV care accordingly, either to help diagnose cancers earlier, or to prevent cancers and deaths from occurring.

Recruitment into CHIPS+ takes place from both NHS paediatric clinics and all adult/adolescent clinics receiving PHIV from paediatric care. Paediatric clinics are sent lists of patients aged 15 years or over (identified through CHIPS), four times a year, and are requested to consent them to CHIPS+ before transfer to adult care. For those already being seen in adult care, the CHIPS form requests the name of the adult clinic to which the young person transferred care, and this is used to contact trace those who have already transitioned, to gain their consent in adult care.

Patients with vertically-acquired HIV who are aged ≥15 years and who have not been previously followed up through CHIPS but have received paediatric care in the UK may still be approached to join the study.

Inclusion Criteria:

1. History of paediatric care in the UK or Ireland

2. At least 15 years of age

3. Able to give informed consent

The study team aimed to recruit 1,100 young people with PHIV study participants by the study end date 31st Dec 2021, but this has been closer to 750.

PATIENT AND PUBLIC ENGAGEMENT

The CHIPS+ steering committee was active while the study was open and recruiting, with three patient representatives who were all women living with HIV and also parents who attended the CHIPS+ steering committee meetings and helped the study to design the patient leaflet about CHIPS and CHIPS+ . The study team also had input from the Youth Trials Board (YTB) in the development of the patient leaflets. The YTB is part of CHIVA and is made up of a group of young people living with HIV who have some background on what clinical trials and studies are. The aim of the YTB is to ensure young people have a meaningful and influential involvement in how clinical trials are designed, developed and delivered.

University College London is the sole Data Controller who will also be processing the data. They are also the sponsor of this study and delegate sponsorship responsibilities to Medical Research Council Clinical Trials Unit (MRC CTU) at UCL. CHIPS+ is currently funded by a grant from the Penta Foundation. The Penta Foundation is a Global charity which seeks to improve the understanding of paediatric infectious diseases, the dynamics of viral transmission and the optimisation of evidence-based treatments. Penta do not make any decisions about the nature of the study nor how the data are analysed, nor the way the study outcomes are published and are therefore not considered a Data Controller. Penta will not be accessing any record-level NHS Digital data under this agreement. There is a co-investigator from Imperial College Healthcare NHS Trust but they have no access to record-level NHS Digital data and no control or influence over the purpose and means of processing.

Flagging data through NHS Digital’s three data products, Demographics, Civil Registration (Deaths) and Cancer Registration Data will allow the MRC CTU at UCL to ensure that deaths and cancer events are captured promptly and comprehensively. Linked data from NHS Digital will therefore improve the estimates of cancers and mortality for young people with PHIV. The demographics dataset has been requested in addition to Civil Registrations (Deaths) data set as it will inform the study team in case participants die outside of the UK or leave the UK.

The data required will be minimised by limiting it to the study cohort, approximately 750 participants, and only from the date of first recruitment onwards (unless subsequently withdrawn from the study). Cumulative incidence and risk factors associated with cancer and mortality will be analysed by the study team up to 10 years after transfer to adult care.

LEGAL BASIS FOR PROCESSING DATA

The Data Controller will process the data under GDPR Article 6 (1) (e) - Processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. As a higher education establishment, the University conduct research to improve health care and service and the linkage requested is necessary for the performance of a task carried out in the public interest; i.e. improving the health outcomes of PHIV patients.

Additionally, under GDPR Article 9(2)(j) processing of Special Category Personal Data is necessary for archiving for research purposes. Data minimisation process is being followed and only data that is required specifically for the purposes of this study has been requested, to protect the rights of the data subjects.

The results of this study are expected to be published in high-impact peer reviewed journals such as Clinical Infectious Diseases or AIDS Care to give the highest impact and broadest readership. Papers are aimed to be published based on UCL open access policy. This would include publication in open access journals, and summaries of results may be made available on the MRC CTU on the UCL website which is freely open to the public.

Outputs will be anonymised to the level required by the Information Standards Board for Health and Social Care (ISB) anonymisation standard and will contain aggregate and suppressed data (according to the HES analysis guide) only.

In addition, it is hoped that the results will be presented at scientific conferences and professional meetings related to HIV. The conferences will be chosen depending on the key findings and also the target audience. Possible conferences include the Children's HIV Association (CHIVA) and the British HIV Association (BHIVA) conferences. This would allow for coverage of key stakeholders in the setting of registry data and clinicians involved in HIV research, as well as young people themselves and their families.

The study team have already produced a leaflet about CHIPS and CHIPS+, targeted at young people themselves, to help the recruitment of young people into the study so the study team plan to produce another leaflet about the findings of CHIPS+. The study team found this worked really well in the Adolescents and Adults Living with HIV Cohort Study (AALPHI) where the study team engaged young people in a project on the dissemination of the findings and they developed a leaflet and film with a graphic designer and film maker. It is hoped that the leaflet will be sent out to participating clinics, and put on the Children’s HIV Association (CHIVA) website. CHIVA is a registered charity based in Bristol which, among other things, aims to enhance the health and social outcomes of children, young people and families living with HIV https://www.chiva.org.uk/about/

The Youth Trials Board, which is part of CHIVA and made up of nine young people who have some training on clinical trials are going to help develop the study dissemination strategy targeting young people. They have suggested using social media to disseminate the results using their twitter chat with @freedom2speak and their Instagram content is being developed in 2022 and could be also used as a platform to share results with young people. They could also do presentations at CHIVA events including CHIVA camp which happens every summer.

The data is still being analysed and so no yielded benefits to date.

There is a substantial knowledge gap about health outcomes of children living with perinatal human immunodeficiency virus (PHIV) worldwide. In 2019 an estimated 1.8 million children and young people (aged 13-24) were living with HIV globally, and even with scale-up of interventions to reduce vertical HIV transmission (When a young person acquires HIV in utero or during birth), there remained an estimated 150,000 new infections among infants in that year alone. The treatment for HIV is called antiretroviral therapy (ART). ART involves taking a combination of HIV medicines (called an HIV treatment regimen) every day. With improved access to ART, a growing number of perinatally infected children and young people will be reaching adolescence and young adulthood over the next two decades.

The UK has some of the first generation of paediatric HIV survivors and a unique opportunity to inform global knowledge on their long-term health outcomes as they enter early adulthood, underpinned by a reasonable sized, virtually complete national paediatric cohort and strong links with adult HIV clinics. No other country in Europe, or indeed globally, has such an integrated paediatric network with high patient ascertainment (and thus less selection bias), high quality data, and professionals and young people working side by side to maximise health outcomes, combined with the ability to track these patients into adulthood. At present very little is known about the risk of cancers and death in adulthood in young people living with perinatal HIV. This group’s risk of cancer may be higher than the general population due to ongoing inflammation from HIV, and long-term exposure to antiretroviral agents. They may also be at risk of higher mortality from a variety of causes.

Studies have shown that health outcomes for chronic conditions are worse in adolescents than in both children and adults, and that poorly-planned transition of care is linked to deteriorating health outcomes. The term 'transition' refers to when children move from being cared for in paediatric services to adolescent/adult clinics.

The importance of transition in young people with PHIV has been acknowledged in many editorials, and paediatric HIV management has been the subject of considerable research. Yet very few studies with comprehensive coverage of the population, minimising selection bias, have addressed the question of health outcomes after transition. There are lots of studies that tell us about cancers and mortality in adults with HIV and data suggests life expectancy is quite similar to the general population, but there are no data on young people with PHIV and their long-term risks of cancers and death. There is therefore a major gap in the global understanding of what these young people can expect as they reach adulthood.

BACKGROUND - The Collaborative HIV Paediatric Study (CHIPS) and the Overarching study, the National Surveillance of HIV in Pregnancy and Childhood (NSHPC);

Since 1989 and across the UK and Ireland, the National Surveillance of HIV in Pregnancy and Childhood (NSHPC), (now known as The Integrated Screening Outcomes Surveillance Service (ISOSS)), has collected data on children with HIV visiting treatment services for the first time, and infants born to women living with HIV. ISOSS is based at the Great Ormond Street Institute of Child Health at UCL. Data are sent from hospitals to ISOSS via pregnancy and child health routine reporting systems, and include demographics (e.g. sex and age) and HIV test results.

CHIPS was established in 2000, and it complemented the NSHPC by collecting follow-up data on children living with HIV. The NSHPC let CHIPS know of any new children with confirmed HIV infection, and CHIPS would then send out annual data collection forms to the clinic caring for the child. Children were followed in CHIPS until they transferred to adult care.

The overall aim of CHIPS is to monitor the health of children with HIV, and help the NHS by checking that clinics are providing the best possible care to children with HIV. CHIPS expanded over the years, and as of July 2020 there were 35 clinics participating in the study. All clinics caring for children living with HIV reported their patients to CHIPS. The Republic of Ireland stopped contributing data to CHIPS in 2018.

Children and their families were not asked to provide consent to participate in CHIPS, as CHIPS is the national surveillance study for children with HIV, and has specific approvals to collect data without consent.

The data collected in CHIPS are used for a range of analyses. An annual report and PowerPoint slides are available on the CHIPS website (www.chipscohort.ac.uk), and give an overview of the data. A range of aspects of paediatric HIV have been investigated, including characteristics of the whole cohort,(1) clinical outcomes at the point of transition to adult care (2) and after transition,(3) as well as response to antiretroviral therapy.(4, 5)

The main CHIPS study closed on March 31st 2021. Due to the recent changes at PHE, (now UKHSA), NHS England will become the new data controller for paediatric HIV surveillance, which will be called the Children’s HIV and AIDS Reporting System (CHARS). Data collection for this new study will be conducted by ISOSS at ICH, UCL. CHARS is due to open from January 2022.

***REFERENCES***

1. Judd A, Doerholt K, Tookey PA, Sharland M, Riordan A, Menson E, et al. Morbidity, mortality, and response to treatment by children in the United Kingdom and Ireland with perinatally acquired HIV infection during 1996-2006: planning for teenage and adult care. Clin Infect Dis. 2007;45(7):918-24.

2. Collins IJ, Foster C, Tostevin A, Tookey P, Riordan A, Dunn D, et al. Clinical status of adolescents with perinatal HIV at transfer to adult care in the UK/Ireland. Clin Infect Dis. 2017;64(8):1105-12.

3. Judd A, Collins IJ, Parrott F, Hill T, Jose S, Ford D, et al. Growing up with perinatal HIV: changes in clinical outcomes before and after transfer to adult care in the UK. J Int AIDS Soc. 2017;20(Suppl 3):71-80.

4. Childs T, Shingadia D, Goodall R, Doerholt K, Lyall H, Duong T, et al. Outcomes after viral load rebound on first-line antiretroviral therapy in HIV-infected children in the UK/Ireland: an observational cohort study. The Lancet HIV. 2015;2(4):e151-e8.

5. Chappell E, Lyall H, Riordan A, Thorne C, Foster C, Butler K, et al. The cascade of care for children and adolescents with HIV in the UK and Ireland, 2010 to 2016. J Int AIDS Soc. 2019;22(9):e25379.

THIS STUDY - Collaborative HIV Paediatric Study (CHIPS)+:

This study aims to provide evidence on health outcomes in early adulthood and will provide the foundation for long-term monitoring. The Collaborative HIV Paediatric Study (CHIPS)+ cohort includes young people (aged 15 years and upwards) from the original CHIPS, a national cohort study of children living with HIV in the UK and is one of the best established cohorts of young people with PHIV in the world. Within this cohort the study team have estimated the risks of cancers and deaths in paediatric care. However, there are no comprehensive estimates of incidence of cancers and deaths in adult care, hence the study team's request to link NHS Digital data to the cohort of CHIPS+ participants (approximately 750 individuals).

The main aim of the CHIPS+ study is to evaluate the short and medium-term health outcomes of young people with PHIV following transition to adult care, by clinic type, and to establish a mechanism to follow this group in the future.

The objectives of the CHIPS+ study is:

1. To consent young people with PHIV aged 15 years and over into a new perinatal HIV adult cohort for CHIPS+ and create a dataset containing life course (paediatric and adult) disease and treatment history

2. To estimate prevalence/incidence of engagement in care and key health outcomes pre- and 1-5 years post-transition, overall and by clinic type

The study requests the linkage to NHS Digital's Demographics, Cancer Registrations, and Civil Registration (Deaths) data sets, to obtain routinely collected data of the CHIPS+ cohort for long-term health outcomes, and to estimate the incidence of cancers and deaths.

This study will provide evidence on health outcomes in early adulthood and will provide the foundation for long term monitoring. The linkage to NHS Digital record-level data, for cancer and mortality data will be critical to estimate the risk of disease progression, hospitalisation and mortality and will help to tailor future HIV care accordingly, either to help diagnose cancers earlier, or to prevent cancers and deaths from occurring.

Recruitment into CHIPS+ takes place from both NHS paediatric clinics and all adult/adolescent clinics receiving PHIV from paediatric care. Paediatric clinics are sent lists of patients aged 15 years or over (identified through CHIPS), four times a year, and are requested to consent them to CHIPS+ before transfer to adult care. For those already being seen in adult care, the CHIPS form requests the name of the adult clinic to which the young person transferred care, and this is used to contact trace those who have already transitioned, to gain their consent in adult care.

Patients with vertically-acquired HIV who are aged ≥15 years and who have not been previously followed up through CHIPS but have received paediatric care in the UK may still be approached to join the study.

Inclusion Criteria:

1. History of paediatric care in the UK or Ireland

2. At least 15 years of age

3. Able to give informed consent, or - for those that lack capacity - assent along with parental/carer consent or consultee assent.

The study team aimed to recruit 1,100 young people with PHIV study participants by the study end date 31st Dec 2021, but this has been closer to 750.

PATIENT AND PUBLIC ENGAGEMENT

The CHIPS+ steering committee was active while the study was open and recruiting, with three patient representatives who were all women living with HIV and also parents who attended the CHIPS+ steering committee meetings and helped the study to design the patient leaflet about CHIPS and CHIPS+ . The study team also had input from the Youth Trials Board (YTB) in the development of the patient leaflets. The YTB is part of CHIVA and is made up of a group of young people living with HIV who have some background on what clinical trials and studies are. The aim of the YTB is to ensure young people have a meaningful and influential involvement in how clinical trials are designed, developed and delivered.

University College London is the sole Data Controller who will also be processing the data. They are also the sponsor of this study and delegate sponsorship responsibilities to Medical Research Council Clinical Trials Unit (MRC CTU) at UCL. CHIPS+ is currently funded by a grant from the Penta Foundation. The Penta Foundation is a Global charity which seeks to improve the understanding of paediatric infectious diseases, the dynamics of viral transmission and the optimisation of evidence-based treatments. Penta do not make any decisions about the nature of the study nor how the data are analysed, nor the way the study outcomes are published and are therefore not considered a Data Controller. Penta will not be accessing any record-level data under this agreement.

Flagging data through NHS Digital’s three data products, Demographics, Civil Registration (Deaths) and Cancer Registration Data will allow the MRC CTU at UCL to ensure that deaths and cancer events are captured promptly and comprehensively. Linked data from NHS Digital will therefore improve the estimates of cancers and mortality for young people with PHIV. The demographics dataset has been requested in addition to Civil Registrations (Deaths) data set as it will inform the study team in case participants die outside of the UK or leave the UK.

The data required will be minimised by limiting it to the study cohort, approximately 750 participants, and only from the date of first recruitment onwards (unless subsequently withdrawn from the study). Cumulative incidence and risk factors associated with cancer and mortality will be analysed by the study team up to 10 years after transfer to adult care.

LEGAL BASIS FOR PROCESSING DATA

The Data Controller will process the data under GDPR Article 6 (1) (e) - Processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. As a higher education establishment, the University conduct research to improve health care and service and the linkage requested is necessary for the performance of a task carried out in the public interest; i.e. improving the health outcomes of PHIV patients.

Additionally, under GDPR Article 9(2)(j) processing of Special Category Personal Data is necessary for archiving for research purposes. Data minimisation process is being followed and only data that is required specifically for the purposes of this study has been requested, to protect the rights of the data subjects.

The results of this study are expected to be published in high-impact peer reviewed journals such as Clinical Infectious Diseases or AIDS Care to give the highest impact and broadest readership. Papers are aimed to be published based on UCL open access policy. This would include publication in open access journals, and summaries of results may be made available on the MRC CTU on the UCL website which is freely open to the public.

Outputs will be anonymised to the level required by the Information Standards Board for Health and Social Care (ISB) anonymisation standard and will contain aggregate and suppressed data (according to the HES analysis guide) only.

In addition, it is hoped that the results will be presented at scientific conferences and professional meetings related to HIV. The conferences will be chosen depending on the key findings and also the target audience. Possible conferences include the Children's HIV Association (CHIVA) and the British HIV Association (BHIVA) conferences. This would allow for coverage of key stakeholders in the setting of registry data and clinicians involved in HIV research, as well as young people themselves and their families.

The study team have already produced a leaflet about CHIPS and CHIPS+, targeted at young people themselves, to help the recruitment of young people into the study so the study team plan to produce another leaflet about the findings of CHIPS+. The study team found this worked really well in the Adolescents and Adults Living with HIV Cohort Study (AALPHI) where the study team engaged young people in a project on the dissemination of the findings and they developed a leaflet and film with a graphic designer and film maker. It is hoped that the leaflet will be sent out to participating clinics, and put on the Children’s HIV Association (CHIVA) website. CHIVA is a registered charity based in Bristol which, among other things, aims to enhance the health and social outcomes of children, young people and families living with HIV https://www.chiva.org.uk/about/]

The Youth Trials Board, which is part of CHIVA and made up of nine young people who have some training on clinical trials are going to help develop the study dissemination strategy targeting young people. They have suggested using social media to disseminate the results using their twitter chat with @freedom2speak and their Instagram content is being developed in 2022 and could be also used as a platform to share results with young people. They could also do presentations at CHIVA events including CHIVA camp which happens every summer.

Yielded Benefits is not a requirement for new applications.