PROTOCOL
Development and Implementation of Positive Voices: the
National Survey of People Living with HIV
Version:
6.0
Document Creation Date:
22nd March 2013
Document Approved Date:
Author:
Meaghan Kall
Approved By:
Revision date
Version
29/01/2014
6.0
Summary of Changes
Update to Phase 2 methodology, update to timeline,
removal of Phase 3 (the national survey), update clinic
list and sample size calculation, replaced wording, logos
and contact information for Public Health England
throughout.
Protocol – National Survey of People Living with HIV
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Table of Contents
Contact Information................................................................................................................................ 4
Protocol Synopsis .................................................................................................................................... 5
Background ............................................................................................................................................. 6
Purpose and Objectives .......................................................................................................................... 7
Project Timeline ...................................................................................................................................... 9
Phase 1 Formative work: ........................................................................................................................ 9
Objectives ........................................................................................................................................... 9
Develop and validate the survey questionnaire (Objective 1) ........................................................... 9
Methods: Cognitive Interviews ..................................................................................................... 10
Inclusion Criteria ........................................................................................................................... 10
Exclusion Criteria........................................................................................................................... 10
Selection of participants ............................................................................................................... 10
Explore the acceptability of the survey and develop incentives to improve uptake (Objectives 2-4)
.......................................................................................................................................................... 11
Methods: Focus Group Discussions .............................................................................................. 11
Inclusion Criteria ........................................................................................................................... 11
Exclusion Criteria........................................................................................................................... 12
Selection of participants ............................................................................................................... 12
Methods: Semi-structured interviews with clinic staff ................................................................. 12
Inclusion Criteria ........................................................................................................................... 12
Exclusion Criteria........................................................................................................................... 12
Selection of participants ............................................................................................................... 12
Methods – Phase 2: Pilot study ............................................................................................................ 13
Objectives ......................................................................................................................................... 13
Inclusion Criteria ............................................................................................................................... 13
Exclusion Criteria............................................................................................................................... 13
Selection of clinics ............................................................................................................................. 14
Randomisation – Tier 1 ..................................................................................................................... 14
Randomisation – Tier 2 ..................................................................................................................... 14
Sample Size ....................................................................................................................................... 15
Selection of participants ................................................................................................................... 16
Clinics assigned to Recruitment Strategy 1, aka Pre-selected recruitment .................................. 16
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Clinics assigned to Recruitment Strategy 2, aka Sequential recruitment ......................................... 16
Data Collection .................................................................................................................................. 18
Data Analysis ..................................................................................................................................... 18
Data Security ......................................................................................................................................... 18
Confidentiality and Data Handling ........................................................................................................ 19
Ethics and Consent ................................................................................................................................ 20
Dissemination of Results ....................................................................................................................... 20
Future work........................................................................................................................................... 20
Funding ................................................................................................................................................. 21
References ............................................................................................................................................ 22
Appendix 1 – Phase 1 Objectives framework ....................................................................................... 23
Appendix 2 – Phase 1 Consent Form .................................................................................................... 24
Appendix 3 – Focus Group Discussion Patient Information Sheet ....................................................... 26
Appendix 4 – Cognitive Interviews Patient Information Sheet............................................................. 28
Appendix 5 – Survey Patient Information Sheet................................................................................... 31
Appendix 6 – Community Support Organisation Contact Sheet........................................................... 33
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Contact Information
Dr. Valerie Delpech – Principal Investigator
Consultant Epidemiologist
Centre/Division HIV & STI Department
Health Protection Services – Colindale
61 Colindale Avenue
Colindale NW9 5EQ
Tel
0208 327 6270
E-mail [email protected]
Meaghan Kall – Survey Coordinator
Scientist (Epidemiology)
Centre/Division HIV & STI Department
Health Protection Services – Colindale
61 Colindale Avenue
Colindale NW9 5EQ
Tel
0208 327 7560
E-mail [email protected]
Dr. Richard Gilson
Senior Clinical Lecturer
Centre/Division Centre for Sexual Health & HIV Research,
UCL Research Department of Infection and Population Health
University College London
Mortimer Market Centre off Capper Street
London WC1E 6JB
Tel
020 7380 9947
E-mail [email protected]
Dr. Anthony Nardone
Consultant Epidemiologist
Centre/Division HIV & STI Department
Health Protection Services – Colindale
61 Colindale Avenue
Colindale NW9 5EQ
Tel
0208 327 6948
E-mail [email protected]
Dr. Maryam Shahmanesh
Senior Clinical Lecturer
Centre/Division Centre for Sexual Health & HIV Research,
UCL Research Department of Infection and Population Health
University College London
Mortimer Market Centre off Capper Street
Tel
020 731082076
E-mail [email protected]
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Protocol Synopsis
Development and implementation of Positive Voices: the national survey of people with
HIV
Location
HIV clinics in England, Wales, and Northern Ireland
Period of study
1 April 2012 – 31 August 2014
Funding
National Institute of Health Research – Public Health Research
Ethics approval
Approved by the London – Harrow Research Ethics Committee (13/LO/0279)
Design
Repeat cross-sectional survey
Sample size
Formative work: 20-35 participants
Pilot survey: 4,182 invitations distributed
Population
HIV positive men and women, 18 years or older
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Background
The numbers of people living with HIV who are well and on antiretroviral therapy is increasing and
represent a substantial burden on NHS resources. There was a five-fold increase in the numbers
accessing care between 1997 and 2006 (HPA, 2011). Over the past 30 years, HIV disease has evolved
rapidly from a condition with a poor short term prognosis to a chronic, long term condition which is
associated with other chronic conditions, including hypertension, cardiovascular disease, diabetes,
osteoporosis, mental and neurocognitive disorders (Friis-Moller 2008, Thiebaut 2005, De Wit 2008,
Worm 2009). At the same time there is a growing body of evidence suggesting that HIV prevention
interventions targeting people living with HIV, positive prevention, should be an important aspect of
overall prevention strategy. Therefore, in order to plan treatment and prevention services there is
an urgent need to better quantify population prevalence of chronic disease co-morbidity among
people living with HIV (PLHIV), and establish population risk factors that may increase susceptibility
to co morbidities, co-infections and sexual risk.
Furthermore, although routine HIV care continues to be delivered by HIV specialist services, PLHIV
are reported to consult their general practitioner four to five times a year (Evans 2009). As the
population of people diagnosed with HIV live longer and their healthcare needs change, there is a
need to reconsider the role of primary and social care in the management of HIV-infection, and the
met and unmet healthcare needs of HIV-positive persons to ensure appropriate provision of
services.
Historically, our understanding of the healthcare needs and risk behaviours of PLHIV has come from
clinic or community based surveys conducted by academic institutions or sexual health charities
(Working with HIV, Project Nasah, What do you need?, Relative Safety, SONHIA, UKCHIC). These
surveys have provided valuable information which allows insights into the HIV epidemic. However,
these surveys have important limitations. Firstly, surveys of PLHIV are ad hoc or occur at irregular
intervals often spaced several years apart and with changing methodologies. While these studies can
provide useful cross sectional information, longitudinal or repeated cross-sectional studies using a
consistent methodology and sampling frame are needed to interpret trends over time. Secondly,
community-based research relies on convenience sampling and opportunistic recruitment, for
example through the internet or patient groups, introduces sampling bias by excluding PLHIV who do
not access such technologies or services. Similarly, surveys in clinical settings also face selection
biases as well as administrative and logistical barriers. Most studies have tended to focus on large
clinics in urban areas, such as London, Manchester, and Brighton. However, evidence from Public
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Health England shows an increasing geographic spread of HIV cases with less than half (42%) residing
in London in 2008, a decrease from 65% in 2000, a trend that is likely to continue (HPA 2012). There
is also evidence of health inequalities and different needs of PLHIV who attend large HIV clinics
compared to PLHIV attending medium sized or smaller clinics (Shickle 2011). As a result, the data
from these surveys have limited generalisability to the wider community of people living with HIV.
There are limited nationally representative surveys of PLHIV. The United States has invested heavily
in the development of a system for collecting information on diagnosed HIV positive individuals,
known as the Medical Monitoring Project (MMP). MMP involves extracting information from
medical records in addition to completion of a questionnaire by PLHIV. A vast amount of resources
(over US$60 million over the past five years) has been invested in achieving a representative sample
of PLHIV in the context of a privatised health care system. In contrast, in the UK we have the benefit
of being able to access, at relatively low cost, a representative sample of PLHIV through a national
register comprising nearly all individuals diagnosed with HIV infection and accessing care. This
protocol describes the development, piloting and conduct of a national survey of a representative
sample of PLHIV.
Purpose and Objectives
The number of people living with HIV in the UK is estimated to reach 100,000 by 2012, as a result of
on-going transmission and effective HIV treatment. HIV is a now a chronic disease associated with
other chronic diseases, such as hyperlipidaemia, hypertension, diabetes, osteoporosis, and
depression. In order to plan health care and prevention services, there is a need to better
understand the patterns of sexual and lifestyle risk behaviour in PLHIV and how this may change
over time. There is also a need to map patterns of HIV associated chronic diseases and risk
behaviours, attitudes and satisfaction with current models of care, to ensure equitable and efficient
access to quality health services.
The project will utilise the existing national census of HIV positive individuals in care [SOPHID] as a
national sampling frame for collecting longitudinal data on social, behavioural, and healthcare needs
of HIV positive persons. SOPHID is a national cross-sectional survey which collects anonymised
demographic, clinical, and treatment data for around 74,000 PLHIV receiving care in England, Wales,
and Northern Ireland. A representative random sample of PLHIV attending HIV clinics will be invited
to complete an on-line questionnaire. Topics covered by the questionnaire include: sexual and drug
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taking behaviours; co-morbidities and risk behaviours associated with chronic disease; current use of
health services; quality of life; satisfaction with care (and attitudes to future possible models of
care); and attitudes to, and experiences of living with HIV.
This is a multi-site cross-sectional study in adults living with HIV who are receiving care in the UK.
The principal objectives of the survey are to determine:
1. What is the prevalence and key determinants of sexual and other health-related risk
behaviours among people living with HIV in the UK?
2. What is the self-reported prevalence of associated chronic diseases (cardiovascular disease,
metabolic conditions, mental/neurocognitive disorders) and their risk factors in people living
with HIV?
3. What are the current models/patterns of accessing care for HIV and associated chronic
conditions?
4. How satisfied are PLHIV with the current standard and model of HIV care?
5. How prevalent is HIV-related stigma and discrimination experienced by people with HIV?
The project aims to make the survey a repeat cross-sectional survey of healthcare needs and sexual
behaviour in HIV positive individuals conducted every two years. The results of this project will
provide valuable insights that will be generalisable to the wider HIV positive community. The data
will be used to inform HIV prevention programmes and by commissioners to evaluate and fund HIV
specialist services.
The project will be carried out in three phases. In Phase 1, the formative phase we will use mainly
qualitative methods with participants and clinics to develop and validate the survey tool and explore
the acceptability and feasibility of a variety of incentives targeting clinics and potential participants
to improve survey response rates. In Phase 2, the pilot phase, the survey will be piloted in 6-8 clinics
which will be randomly allocated one of four combinations of interventions in a factorial design
aimed at optimising participation and feasibility of delivery. Phase 3 will employ the optimal delivery
strategy on a national scale and invite a random sample of PLHIV to complete the survey.
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Project Timeline
Jan 13 Feb 13
Mar 13 Apr 13
May 13 - July 13 Jun 13
Aug 13
Sept 13 - Nov 13 Oct - 13 Dec 13
Jan 14 Feb 14
Mar 14Apr 14
May 14 - July 14 June 14 Aug 14
Ethics Application
Phase 1: Focus Group
Discussion (FGD)
Phase 1: Cognitive
interviews (CI)
Phase 1: Semi-structured
interviews (SSI)
Questionnaire
Development*
Phase 2: R&D approval
for study sites
Phase 2: Pilot Study
Phase 2: Post- Study Site
Follow Up
* Including the analysis and incorporating of the results of Phase 1 work on a rolling basis
Phase 1 Formative work:
Objectives
The overall aim of Phase 1 is to develop and validate the survey tool and identify incentives to
improve survey uptake. Mainly qualitative methods will be used to fulfil the following objectives
(Appendix 1).
1. Develop and validate the survey instrument
2. Explore the barriers and facilitators to implementing a patient survey in HIV clinic
settings
3. Examine the extent to which the internet and technology are used and trusted
4. Identify and explore the acceptability of various incentives for completing the survey
Develop and validate the survey questionnaire (Objective 1)
The survey questionnaire will be developed based on a set of domains devised to answer the
objectives of the survey (see Positive Voices Questionnaire v1 ). A thematic framework of questions
will be constructed using previously validated questions (i.e. National Attitudes Towards Sex and
Lifestyle III [NATSAL], 2010 UK; Health Survey for England [HSE] & Health and Social Care Survey
[HSCS], UK; Medical Monitoring Project, USA 2009; Positive Health Study, Australia 2007; HIV
Futures Study, Australia 2012; What do you need?, Sigma Research, UK).
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A draft questionnaire will be assembled using the Delphi method. We have assembled an expert
panel, including representatives of service users, providers, commissioners and academics (the
Advisory Group) who will provide feedback on the items included in the draft questionnaire. Once
we have agreement on the items included we will test this with 12-15 volunteer participants using
cognitive interviewing (Willis 1999). Cognitive interviewing will be the method used to validate the
questionnaire, both in content and presentation. Specifically the aims are to assess acceptability of
the questions, the degree to which the questions are understood as intended, gauge reaction to the
structure and visual layout of the questionnaire, ensure the terminology is clear and appropriate,
and measure the time taken to complete the questionnaire.
Methods: Cognitive Interviews
Participants will be asked to complete the full questionnaire, one section at a time (approximately 10
questions) and highlight the questions they did not understand or had difficulty answering. They will
be asked at the end of each section about their difficulty or ease in understanding the wording and
meaning of the questions, and how they interpreted and derived responses to the questions. If they
do not understand the questions, the researcher will seek their suggestions to improve the
comprehension of the questions. They will then be asked questions about the overall impact of the
survey. The process will take up to 2 hours per person. Participants will be compensated £40 for
their time. Throughout the process, outcomes of the cognitive interviews will be incorporated
wherever possible to improve the survey.
Inclusion Criteria
• HIV positive
•
Aged 18 and over
•
Accessing care at an NHS HIV clinic
•
Agreed to participate in qualitative interview
Exclusion Criteria
• Unable to speak English
•
Declines audio recording of the discussion
Selection of participants
Three clinics will be identified with active patient support groups or HIV service organisations. The
researcher will be introduced to the group members during one of their meetings with prior consent
of the members. The researcher will explain the purpose of the survey and invite 4-5 participants to
volunteer to test the questionnaire. Individuals that agree will be asked to leave their contact details
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with the group Chair, who will then pass the information onto the researcher. The researcher will
contact the potential participant and schedule an interview to take place at the clinic at the
convenience of the participant.
Explore the acceptability of the survey and develop incentives to improve
uptake (Objectives 2-4)
We will use qualitative methods of data collection to assess the acceptability of the survey to both
PLHIV and HIV clinic staff. We will make use of vignettes and ranking as a tool to explore potential
incentives to improve participation. The qualitative work will be iterative with data from FGD and
semi structured interviews feeding into the next phase. Qualitative data will be entered into NVIVO
and analysed using Framework analysis (Ritchie, 1994).
Methods: Focus Group Discussions
In the focus group discussions (FGDs), a topic guide will be used to facilitate the discussion. Main
topics for the focus group discussions will include:
•
Overall acceptability of completing a health survey distributed through clinic settings
•
Acceptability of, and barriers to the use of potential technologies and modes of delivering
the questionnaire (i.e. internet access, use of mobile technology, where patients are likely to
complete the survey)
•
Explore the need for translation and alternatives such as audio and/or pictorial prompts
•
Means of incentivising participants to complete the survey using vignettes and ranking
methods
The researcher will facilitate the discussion among the participants. It is anticipated that the FGD will
last for approximately 60-70 minutes. Participants will be compensated £40 for their time. The
discussion will be audio-recorded. However, no identifiable data or names of participants will be
recorded. The FGD data will be analysed by the researcher using qualitative data analysis software
NVivo (QSR International Pty Ltd. Version 10, 2012).
Inclusion Criteria
• HIV positive
•
Aged 18 and over
•
Accessing care at an NHS HIV clinic
•
Agreed to participate in qualitative interview
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Exclusion Criteria
• Unable to speak English
•
Declines audio recording of the discussion
Selection of participants
The focus groups will be identified with the help of three clinics with active patient support groups.
Three GUMNet clinics will be approached to participate in the study. Care will be taken to ensure
that the clinic populations are representative of the HIV population. Once the clinics are identified,
the researcher will visit each clinic and be introduced to the group members during one of their
meetings with prior consent of the members. The researcher will invite approximately 6-8 members
to volunteer to participate in a focus group discussion.
Methods: Semi-structured interviews with clinic staff
Semi-structured interviews with clinic staff will be conducted by the researcher via telephone using
an interview guide. The guide will include both open-ended and closed questions. The aims of the
interviews are as follows:

Explore the logistic barriers to this survey in the clinic

Gain understanding of the clinic’s patient pathway and facilities currently available in the
clinic

Explore things that would make the survey attractive to the clinic and facilitate the survey
e.g. adding questions about satisfaction with care, giving clinic specific rapid feedback,
adding questions important for commissioners
The interview will include no more than 20 questions (although most will have less questions due to
relevant skips) and is expected to take no more than 20 minutes.
Inclusion Criteria
• Doctor, nurse, nurse assistant, or reception staff currently employed at an HIV specialist
clinic that is part of GUMNet.
Exclusion Criteria
• Declines audio recording of the discussion
Selection of participants
For the staff interviews, GUMNet clinics have been selected due to the existing working relationship
between Public Health England and these sentinel sites. GUMNet clinics that provide treatment and
care to PLHIV will be selected based on i) annual patient volume – large and small sites, and ii)
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geographical representation of inside and outside London. Up to 10 clinics are envisaged to
interview, with 1-2 staff members interviewed per site. The researcher will call the selected clinics,
and ask for a doctor, nurse, nurse assistant, or reception staff. If none are available, contact details
and a message will be left and asked to ring at their convenience. Quotas will be applied to ensure a
distribution of staff categories among respondents.
Methods – Phase 2: Pilot study
Objectives
The purpose of the pilot phase is to identify a practical strategy for delivering an HIV patient
survey through NHS HIV specialist services. The pilot study is a two tiered factorial randomised
controlled trial designed to assess the acceptability and feasibility of i) two different strategies for
recruiting patients and ii) offering an incentive to patients for completing the survey. The primary
objectives are to:
•
Determine which recruitment strategy achieves the highest response rate
•
Determine whether a prize draw incentive results in the highest response rate
•
Evaluate the characteristics and representativeness of the respondent sample (compared
to SOPHID)
•
Identify predictors of survey responders vs. non-responders
•
Assess the feasibility of delivering the survey in the clinic setting
•
Assess the quality and completeness of data in completed surveys
•
Explore the acceptability of the survey to participants
Inclusion Criteria
•
HIV positive
•
Aged 18 and over
•
Reported to SOPHID in the previous calendar year (2012)
Exclusion Criteria
•
Unable to complete the online questionnaire due to access issues (for example, language or
literacy barriers, visual impairment, no access to the internet) and unable to use the
alternative means of completing the survey that are made available.
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Selection of clinics
Thirty pilot clinics will be identified through the SOPHID network. Clinics will be purposively selected
by population characteristics, clinic size, and geographical regions. Clinics that approached Public
Health England to participate were also considered. Table 1 shows the list of participating clinics.
Randomisation – Tier 1
The first randomisation is a cluster randomisation, and clinics will be randomised to one of two
recruitment strategies:
Recruitment Strategy 1 – Recruitment of patients from a pre-selected list generated by Public
Health England. In this strategy a random sample of patients will be drawn from the clinic’s most
recent SOPHID register (2012), and survey invitations will be created and addressed for specific
patients. Clinics assigned to this strategy will recruit patients for 4 months. The number of patients
selected will vary by clinic size, and are shown in Table 1.
Recruitment Strategy 2 – Recruitment of sequential patients attending clinic. Clinics assigned to
this strategy will recruit patients until all survey invitations have been distributed, or for four
months, whichever comes first. The start date and the date that the final invitation is distributed
will be recorded.
Randomisation will be done using permuted-block randomisation scheme to ensure balanced
assignment to study arms within blocks. Clinics will be stratified into groups of 4 based on size
(number of patients reported to SOPHID in 2012) and randomly assigned in 1:1 ratio to the 2 study
arms.
Randomisation – Tier 2
The second randomisation is at the patient level, and will randomise potential participants to
either a control – a standard survey invitation pack, or to receive a survey invitation pack with an
incentive of optional entry into a prize draw to win one of 10 prizes of £200 Love2Shop high street
vouchers for completing the survey. Winners will be drawn periodically throughout the study. The
incentive of a prize draw was chosen based on the results of Phase 1 work, whereby patients
expressed an interest in both non-monetary incentives to complete the survey, and monetary
incentives such as vouchers. Budget limitations restrict the total spend on incentives to £2,000. A
systematic review has shown there is inconclusive evidence that the value of the prize draw
improves response rates, however some studies have shown that “moderate” prize amounts
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result in better response rates than “small” prize amounts, but equivalent to “large” prize
amounts (Edwards 2009). Values are relative to local currency and average income, however in
most studies a “moderate” prize was estimated to be between £100 and £500. Response rates are
also higher when participants feel they have a high probability of winning (Porter 2003). Assuming
around 2,000 respondents, 10 prizes would give a 1 in 200 chance of winning.
Patients selected for recruitment from clinics in the Recruitment Strategy 1 (Pre-selected
recruitment) arm will have their Tier 2 randomisation pre-assigned and the randomisation linked
to their unique survey identifier.
Patients from clinics assigned to Recruitment Strategy 2 (Sequential recruitment) will be
randomised when they receive their invitation pack at the clinic. These clinics will distribute
survey invitations in sealed, opaque envelopes which are in a random sequence. The
randomisation will be linked to the unique survey identifier provided in the invitation, and
entered into the survey.
Clinic staff are blinded to this randomisation as the invitation packs are sealed and randomisation
is revealed once the patient has accepted and opened the envelope. Clinics are instructed to give
only one envelope to each patient.
Zelen’s design will be used, wherein potential participants are randomized to either the
intervention or control group before giving informed consent. Because the group to which a given
participant is assigned is known, consent will be implied on completion of the survey itself
(although a short consent statement will also be included at the start of the survey). The benefit of
using this method is that it will allow a “real life” recruitment situation, as randomisation will not
interfere with or delay recruitment. Also, this will result in a decreased burden on clinics as survey
invitation packs will be generated and distributed in a single batch at the start of the survey.
Sample Size
A simple sample size calculations was performed based on the main study aim to detect a
difference in response rate from 50% to 60% between Recruitment Strategy 1 and Recruitment
Strategy 2.With 80% power and a significance level of 5%, we require 388 per study arm. A design
effect adjustment was used to account for the cluster randomised study design. Assuming an
intra-cluster correlation coefficient (ICC) of 0.02, and using 30 clusters (clinics) with size
determined from the 2012 SOPHID return.
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The final sample size calculation was determined to be 2,091 per arm, with individual cluster
contribution listed in Table 1 (the proportion of the total clinic size is listed in the final column).
Selection of participants
Clinics assigned to Recruitment Strategy 1, aka Pre-selected recruitment
The 2012 SOPHID records will be extracted for each clinic. Using STATA, a random sample of
patients will be drawn using STATA based on the sample size calculated for each clinic (see Table
1). Selected patients will be assigned a unique identifier created at Public Health England so that the
questionnaire survey responses can be linked back to clinical, laboratory and demographic data from
SOPHID. The link between the clinic patient record number and the unique survey identifier will be
kept secure and separate from other data files and all analyses will be conducted using only the
survey identifier. Invitation packs in sealed envelopes addressed to the selected PLHIV will be
prepared and sent to the clinics for clinic staff to distribute to the identified individuals. All
documentation in the pack and the survey questionnaire itself will be labelled using the survey
unique identifier.
Selected patients will initially be approached by HIV clinic staff, who will hand out the study
invitation and briefly inform the patient about the study and how to participate. If a patient
declines the survey invitation, the invitation will be retained in the clinic and marked as refused,
and not offered to any other patient. Similarly, invitations for pre-selected patients who do not
attend clinic during the study period will be retained. Declined and leftover invitations will be
returned by pre-paid envelope at the end of the study. Clinics will be asked to start recruitment on
a day of their choosing, and to continue for 4 months.
If a patient would like more information about the study, they will be asked to take the survey
invitation with them, and to contact the study coordinator using the contact details inside the
pack. Posters and leaflets explaining the purpose of the study will be distributed to the
participating clinics and various HIV advocacy group web sites.
Clinics assigned to Recruitment Strategy 2, aka Sequential recruitment
Clinics will be sent survey invitations packs which include a unique survey identifier, which is not
linked back to a SOPHID record. The number of survey invitations each clinic will receive is listed
under Sample Size in Table 1. Clinics will be asked to start recruitment on a day of their choosing,
and to distribute a survey invitation to every adult patient who attends clinic. Recruitment will
continue until there are no remaining survey invitations, or up to 4 months, whichever comes first.
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Patients will initially be approached by HIV clinic staff, who will hand out the study invitation.
When a survey invitation is given out, a removable tab will be torn off, labelled with the local
clinic ID, and the tab retained in clinic. If a patient declines the survey invitation, the invitation will
be retained in the clinic and marked as refused, and not offered to any other patient. The tabs will
be returned by pre-paid envelope at the end of the study.
If a patient would like more information about the study, they will be asked to take the survey
invitation with them, and to contact the study coordinator using the contact details inside the
pack. Posters and leaflets explaining the purpose of the study will be distributed to the
participating clinics and various HIV advocacy group web sites.
Table 1: Participating Clinics by Recruitment Method Randomisation and Target Sample Size*
Clinic
Chelsea and Westminster
Mortimer Market Centre
St. Mary's Hospital
North Manchester General Hospital
St. George's Hospital
Queen Elizabeth Hospital
Leicester Royal Infirmary
Heartland Hospitals
Homerton Hospital
Southmead Hospital
Royal Hallamshire Hospital
Royal Victoria Infirmary - Newcastle
Royal Victorial Hospital - Belfast
Royal Bournemouth Hospital
Cardiff Royal Infirmary
Addenbrookes Hospital
James Cook University Hospital
Norfolk & Norwich
Southend Hospital
Watford General Hospital
Kingston Hospital
Walsall Manor Hospital
Gloucester Royal Hospital
Derriford Hospital
Dudley Group of Hospitals
Great Western Hospital
Royal Gwent Hospital
Ipswich Hospital
York Hospital
Weymouth Hospital
Clinic
Size
4362
3968
2934
1781
1376
1144
966
899
886
833
814
694
667
564
405
386
363
357
351
348
347
347
283
256
215
206
189
171
129
74
Recruitment Method
Preselected
Sequential
Sequential
Preselected
Sequential
Preselected
Preselected
Sequential
Preselected
Sequential
Sequential
Preselected
Preselected
Sequential
Preselected
Sequential
Sequential
Preselected
Preselected
Sequential
Preselected
Sequential
Preselected
Sequential
Sequential
Preselected
Sequential
Preselected
Sequential
Preselected
Sample Size (# of patients
to invite)
440
400
340
280
275
229
193
180
177
167
163
139
133
113
81
77
73
71
70
70
69
69
57
54
50
50
46
46
40
30
% of
SOPHID
10.1%
10.1%
11.6%
15.7%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
20.0%
21.1%
23.3%
24.3%
24.3%
26.9%
31.0%
40.5%
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* Note that Sample Size refers to number of patients who are given survey invitations, i.e. the
sample size is equal to the number of survey invitations distributed.
Data Collection
Inside the invitation pack will be a card with the web address of the survey and unique study
identifier.. When the participant visits the survey webpage, they will be asked to logon using their
unique study identifier.
When the participant is logged in, the participant will be shown information about the survey (the
patient information sheet – Appendix 5), links to community support resources (Appendix 6),
contact details of the researchers, and a consent statement they must agree to before proceeding.
From that point the participant will be taken through the survey, which should take 20-30 minutes to
complete, depending on the skip pattern applicable to them. Participants can leave the survey at any
time, or save their responses and return to complete the survey.
At the end of the survey, participants will be given the option to enter the prize draw. After
participants press the submit button they will be shown the final page with a link to click to enter
the prize draw, along with the prize draw terms and conditions. The link will open a new page,
which will ask patients to enter either their email address or phone number to be contacted if
they win. Participants will be assured that these contact details will be kept separate from their
survey responses and deleted after the prize draw.
Data Analysis
Survey responses will be collected in a database held at Public Health England. The data will be
exported to statistical analysis software and data cleaning and management will be done.
Descriptive analysis and univariate analysis to explore the relationship between key variables will be
conducted using t-test for normally distributed variables, Mann-Whitney test for non-normally
distributed variables and chi-square test for categorical variables. Logistic regression analysis will be
conducted to examine factors associated with response rates between different intervention arms.
Data Security
The data will be securely held at the HIV & STI department, Public Health England. All databases will
be password protected and the password only available to team members. Data collection, storage
and use will be consistent with the procedures described in the NHS Information Governance
Toolkit.
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After the random sample of individuals has been selected from the most recent year's SOPHID
records, a unique identifier will be created at Public Health England. The link between the clinic
patient record number and the unique survey identifier will be kept secure and separate from other
data files and all analyses will be conducted using only the survey identifier.
When survey responses are received at Public Health England, they will be linked back to clinical,
laboratory and demographic data in SOPHID (for patients from the “Pre-selected Recruitment Arm”
this will be automatically done using a look up table with the unique study identifier and SOPHID
number. For patients from clinics assigned to “Sequential Recruitment Arm” this will be done at
the end of the study once the local clinic IDs are received and linked to the unique study
identifier). Once the SOPHID data and survey data are merged, all data management and analysis
will done on a dataset without personal identifiers. No patient identifiable information will be
collected in the survey. This is explicitly stated in the participant information sheet.
Confidentiality and Data Handling
HIV is a sensitive research topic and it is important to ensure that patient confidentiality is
maintained. The questionnaire will be sent through a secure web server and the data encrypted and
held centrally on a password protected database at Public Health England. Participants will be
assigned a unique study identifier, and participants will not be asked to provide identifiable
information for the main survey. Participants that choose to enter the prize draw will be asked to
provide either a phone number or an email address to contact them if they win. This information
will be unlinked from the survey response and will be stored securely on a separate password
protected database at Public Health England, and deleted at the end of the pilot study.
Transcripts of qualitative interviews will be anonymised and once transcripts have been checked,
the digital recordings of interviews destroyed. Interview participants will be asked whether they are
happy for anonymised quotes to be included in reports or publications. Signed consent forms will be
stored in a locked cabinet.
All researchers involved in data linkage have been trained in handling data according to Caldicott
guidelines and section 60 of the Health and Social Care Act. All researchers are aware of the Data
Protection Act 1998 and the need to maintain absolute confidentiality.
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Ethics and Consent
This study has been approved by the London – Harrow Research Ethics Committee (13/LO/0279).
The project will be subject to NHS Research and Development approval at the lead and each
participating site before any study procedures are undertaken.
Phase 1: The participant information sheets will be provided for the FGD and Cognitive Interviews
and written consent obtained. The interviews/FGDs will be audio-recorded; this will be explicit in the
information sheet. Patients will be informed that they can withdraw their consent and leave the
group at any time. The researcher can refer participants to appropriate support services in the clinic
service should the need arise. Patient information sheets and consent form for Phase 1 of the study
are included in Appendix 2, 3, and 4.
Phase 2 (pilot): The invitation pack will include a patient information sheet for the project (Appendix
5). Once the patient has logged into the survey, the patient information sheet will be shown again,
and consent to the survey will be given by the patient by ticking a box to continue the survey.
A sheet with contact details for community support organisations will be provided with the patient
information sheets and in electronic form at the start and end of the online survey (Appendix 6).
Dissemination of Results
The results of the study will be disseminated first in an interim report based on the results of the
survey questionnaire pilot interviews and focus group discussion. We will also disseminate the
results on a study webpage, through peer reviewed scientific journals, presentation at conferences,
institutional websites, and via HIV focussed websites like NAM, HIV Treatment Update.
The study will be the subject of a PhD thesis (to be submitted by Ms Meaghan Kall).
Future work
If shown to be feasible, the survey methodology will provide an infrastructure for obtaining further
information from a representative sample of PLHIV under care. The survey can be repeated with a
new sample at intervals, allowing analysis of changes over time in the population. It is also possible
to repeat the survey in the same participants, to provide data for longitudinal analyses. Additional or
alternative questions can be added to subsequent rounds of the survey to address further or
different questions. The anonymised dataset will be made available to collaborating researchers
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subject to an application being made to, and approved by the Advisory Group for Behavioural
Surveillance of people living with HIV.
Funding
The project is funded by a research grant from the NIHR Centre for Public Health Research. External
research funding will be sought with collaborators to address additional questions and to support
further rounds of the survey.
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References
Health Protection Agency. HIV in the United Kingdom: 2010 Report. London: Health Protection
Agency. November 2010.
Friis-Moller N, Smieja M, Klein D. Antiretroviral therapy as a cardiovascular disease risk factor: fact or
fiction? A review of clinical and surrogate outcome studies. Curr.Opin.HIV AIDS 2008;3:220-5.
Thiebaut R, El Sadr WM, Friis-Moller N, Rickenbach M, Reiss P, Monforte AD et al. Predictors of
hypertension and changes of blood pressure in HIV-infected patients. Antivir.Ther. 2005;10:811-23.
De Wit S, Sabin CA, Weber R, Worm SW, Reiss P, Cazanave C et al. Incidence and risk factors for new
onset diabetes in HIV-infected patients: the Data Collection on Adverse Events of Anti-HIV Drugs
(D:A:D) study. Diabetes Care 2008;31:1224-9.
Worm SW, De Wit S, Weber R, Sabin CA, Reiss P, El Sadr W et al. Diabetes mellitus, preexisting
coronary heart disease, and the risk of subsequent coronary heart disease events in patients
infected with human immunodeficiency virus: the Data Collection on Adverse Events of Anti-HIV
Drugs (D:A:D Study). Circulation 2009;119:805-11.
Evans H, Tsourapas A, Mercer CH, Rait G, Bryanet S. Primary care consultations and costs among HIV
positive individuals in UK primary care 1995-2005: a cohort study. Sex Transm Infect 2009;85:543549.
Public Health England. Accessing Care National HIV Tables 2011. August 2012.
http://www.phe.gov.uk/webc/HPAwebFile/HPAweb_C/1221482342808
Shickle D. HIV health inequalities – why we need to better understand people who live with HIV.
University of Leeds. Personal Communication. October 2010.
Richie J and Spencer L. Qualitative data analysis for applied policy research. Bryman and Burgess,
eds., Analysing Qualitative Data, London: Routledge, 1994; 173-194.
Edwards PJ, Roberts I, Clarke MJ, Diguiseppi C, Wentz R, Kwan I, Cooper R, Felix LM, Pratap. Methods
to increase response to postal and electronic questionnaires. S.Cochrane Database Syst Rev. 2009 Jul
8;(3):MR000008.
Porter SR, Whitcomb ME. The impact of lottery incentives on student survey response rates.
Research in Higher Education 2003;44(4):389-407.
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Appendix 1 – Phase 1 Objectives framework
Objective
Method
Participants
Develop and validate the
Cognitive interviews with PLHIV
PLHIV purposive sample
survey instrument
(n=12-15)
representing different age,
gender, sexual orientation,
ethnicity.
Examine the extent to which
FGD (n=3) with patient groups
PLHIV purposive sample
internet and phones are used
Semi-structured telephone
representing different age,
and trusted
interviews with key
gender, sexual orientation,
stakeholders including clinic
ethnicity and clinical settings.
staff and patient advocates
The clinics will be chosen to
(n=10-15)
represent the range of HIV
specialist centres, i.e. a large
inner London, medium nonLondon and small periphery of
London clinic.
Explore the barriers and
FGD with patient groups
PLHIV As above
facilitators to conducting a
Semi-structured telephone
Clinic staff will be chosen from
health survey through HIV
interviews with key
the same clinics (n=10) to
clinics
stakeholders including clinic
represent clinical leads, nursing
staff and patient advocates
lead, reception lead and Health
(n=10-15)
Advisors.
Patient advocates will be
recruited through UKCAB, the
patient treatment advisory
board.
Identify and explore potential
FGD with patient groups
incentives and their
Semi-structured telephone
acceptability and feasibility in
interviews with key
different clinic settings
stakeholders including clinic
As above
staff and patient advocates
(n=10-15)
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Appendix 2 – Phase 1 Consent Form
CONSENT FORM
A Study of the Survey Design, Development, and Validation of Positive Voices:
the National Survey of People Living with HIV
This study has been approved by the London – Harrow Research Ethics Committee (13/LO/0279).
Please initial all boxes
1.
I confirm that I have read and understand the information sheet dated 02/2013
(version 1.0) for the above study. I have had the opportunity to consider the
information, ask questions and have had these answered satisfactorily.
2.
I understand that my participation is voluntary and that I am free to withdraw at any
time without giving any reason, without my medical care or legal rights being affected.
3.
I understand that my interview will be audio-recorded and I consent to the use of this
material by the research team, possibly including verbatim quotes.
4.
I understand that information I provide for this study will be treated as strictly
confidential and handled in accordance with the Data Protection Act 1998. I am assured
that no personal identifying information will be kept which could link me to my
responses.
5.
I understand that data collected during the study may be looked at by individuals from
Public Health England, from regulatory authorities or from the NHS Trust where it is
relevant to my taking part in this research. I give permission for these individuals to have
access to my records.
6.
I agree to take part in the above study.
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Name of Participant
Date
Signature
Name of Person taking consent
Date
Signature
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Appendix 3 – Focus Group Discussion Patient Information
Sheet
PATIENT INFORMATION SHEET
A Study of the Survey Design, Development, and Validation of
Positive Voices: the National Survey of People Living with HIV
Focus Group Discussion
This study has been approved by the London – Harrow Research Ethics Committee (Project ID
13/LO/0279).
You are being invited to take part in a research study. Before you decide, it is important that you
understand why the research is being done and what it will involve. Please read the information sheet
carefully and ask us if there is anything unclear or if you want more information. Take time to decide
whether or not you wish to take part. Thank you for your time.
What is the purpose of the study?
The number of people living with HIV in the UK is rising year on year, as a result of effective
HIV treatment and new HIV diagnoses. Nearly 75,000 people were diagnosed and
accessing HIV specialist services in the past year, and while we collect good data on the
demographic and clinical characteristics of these individuals, little is known about the
lifestyles, health, attitudes, and experiences of people with HIV. We aim to set up a national
internet-based questionnaire survey for people with HIV, and the purpose of this focus group
discussion is to explore the barriers and facilitators to implementing such a survey from your
point of view.
Why have I been invited?
You have been invited to participate as you are an adult living with HIV attending an NHS
clinic for your HIV treatment and care.
Do I have to take part?
You do not have to take part in the study. It is your choice to decide if you want to take part
or not. If you decide you do want to take part and sign a consent form, you are still free to
withdraw from the study at any point should you wish to, without giving a reason. Your
healthcare and legal rights will not be affected if you do not wish to take part in the study. If
you withdraw, any information you have provided up to the point of withdrawal will still be
used for the purposes of the study.
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What will happen to me if I take part?
Taking part in the study involves you being part of a focus group discussion alongside 5-7
other people living with HIV, which will be facilitated by the researcher. The focus group will
take part at your usual clinic, or at some meeting point familiar to the group. The discussion
will last for approximately 60-70 minutes, and will be audio-recorded. However, no
identifiable data or names of participants will be recorded. The main topics of the discussion
will be the overall acceptability of completing a survey through the clinic setting, attitudes
toward and access to internet and technology, preferences for various modes of delivering
the questionnaire, and what sort of incentives we could use to encourage patients to
complete the survey. Your level of participation and input is up to you.
Will my taking part in the study be kept confidential?
All discussions during the Focus Group will be confidential to the participants involved in the
discussion. You will be reminded of the confidential nature of the discussions at the
beginning of the Focus Group session. The information you provide will be treated as strictly
confidential and handled in accordance with the Data Protection Act 1998. The audio
recording will be kept secure in a locked cabinet and destroyed immediately after the
interview has been transcribed. No identifiable information will be kept with the recording or
transcript. Excerpts from the focus group may be taken word for word for reports, but you will
be referred to anonymously, i.e. Patient 3.
What are the disadvantages or risks of taking part?
There are no disadvantages of taking part in the study. Your confidentiality will be
maintained at all times, and you are not obliged to answer a question if you do not want to.
Will the study benefit me?
You will be compensated £40 for your time for participating in this study. Your input will help
us to design a survey that not only collects the best quality information, but also ensures that
we do so in a way that is acceptable and accessible to the community of people with HIV.
Furthermore, the data from the survey is expected to benefit the HIV patient population as a
whole by improving the planning and commissioning of NHS treatment and care services.
Who is organising and funding the research?
This project is being organised by Public Health England and University College London,
and is funded by a grant from the NIHR Centre for Public Health Research.
What do I do if I have any questions or complaints about the study?
If you are unhappy about any part of the study, please discuss your concerns with the
research team using the contact details below. If you are still unhappy and wish to make a
formal complaint you can telephone patient support services at Camden PCT on 020 3317
3003, or email [email protected]. More information is available at
www.camden.nhs.uk/patientsupportservices.
Meaghan Kall
Study Coordinator
Public Health England
Email: [email protected]
Phone: 02083277560
Vicky Gilbart
Research Nurse
Public Health England
Emaill: [email protected]
Phone: 02083277697
You will be given a copy of this information sheet and signed consent form for your records.
Thank you for your time.
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Appendix 4 – Cognitive Interviews Patient Information Sheet
PATIENT INFORMATION SHEET
A Study of the Survey Design, Development, and Validation of
Positive Voices: the National Survey of People Living with HIV
Cognitive Interview
This study has been approved by the London – Harrow Research Ethics Committee”. (Project ID
13/LO/0279).
You are being invited to take part in a research study. Before you decide, it is important that you
understand why the research is being done and what it will involve. Please read the information sheet
carefully and ask us if there is anything unclear or if you want more information. Take time to decide
whether or not you wish to take part. Thank you for your time.
What is the purpose of the study?
The number of people living with HIV in the UK is rising year on year, as a result of effective
HIV treatment and new HIV diagnoses. Nearly 75,000 people were diagnosed and
accessing HIV specialist services in the past year, and while we collect good data on the
demographic and clinical characteristics of these individuals, little is known about the
lifestyles, health, attitudes, and experiences of people with HIV. We aim to set up a national
internet-based questionnaire survey for people with HIV, and the purpose of this interview is
to pilot this questionnaire with patients to gauge the comprehension and clarity of the
questions.
Why have I been invited?
You have been invited to participate as you are an adult living with HIV attending an NHS
clinic for your HIV treatment and care.
Do I have to take part?
You do not have to take part in the study. It is your choice to decide if you want to take part
or not. If you decide you do want to take part and sign a consent form, you are still free to
withdraw from the study at any point should you wish to, without giving a reason. Your
healthcare and legal rights will not be affected if you do not wish to take part in the study. If
you withdraw, any information you have provided up to the point of withdrawal will still be
used for the purposes of the study.
What will happen to me if I take part?
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If you take part in the study, you will be asked to complete the full questionnaire, one section
at a time (approximately 10 questions) and highlight the questions you do not understand or
have difficulty answering. You will be asked at the end of each section about your difficulty or
ease in understanding the questions, and how you interpreted and gave responses to the
questions. If you do not understand the questions, the researcher will ask for suggestions on
how to improve the comprehension of the questions. The interview will take part at your
usual clinic, and will last for approximately 2 hours. The interview will be audio-recorded, but
no identifiable data or names will be recorded. Your level of participation and input is up to
you.
Will my taking part in the study be kept confidential?
Yes, the information you provide for this study will be treated as strictly confidential and
handled in accordance with the Data Protection Act 1998. The audio recording will be kept
secure in a locked cabinet and destroyed immediately after the interview has been
transcribed. No identifiable information will be kept with the recording or transcript. Excerpts
from the interview may be taken word for word for reports, but you will be referred to as a
number, i.e. Participant 3.
What are the disadvantages or risks of taking part?
Some of the questions deal with sensitive or personal topics and you may find them
distressing or embarrassing. You are not obliged to answer a question if you do not want to.
If you wish to seek support or counselling, contact details of community support
organisations have been provided, or if immediate assistance is needed please alert the
researcher. Contact details are provided below.
Will the study benefit me?
You will be compensated £40 for your time for participating in this study. Your input will help
us to design a survey that not only collects the best quality information, but also ensures that
we do so in a way that is acceptable and accessible to the population of people with HIV.
Furthermore, the data from the survey is expected to benefit the HIV patient population as a
whole by being used by improving the planning and commissioning of NHS treatment and
care services.
Who is organising and funding the research?
This project is being organised by Public Health England and University College London,
and is funded by a grant from the NIHR Centre for Public Health Research.
What do I do if I have any questions or complaints about the study?
If you are unhappy about any part of the study, please discuss your concerns with the
research team using the contact details below. If you are still unhappy and wish to make a
formal complaint you can telephone patient support services at Camden PCT on 020 3317
3003, or email [email protected]. More information is available at
www.camden.nhs.uk/patientsupportservices.
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Meaghan Kall
Vicky Gilbart
Study Coordinator
Research Nurse
Public Health England
Public Health England
Email: [email protected]
Emaill: [email protected]
Phone: 02083277560
Phone: 02083277697
You will be given a copy of this information sheet and signed consent form for your records.
Thank you for your time.
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Appendix 5 – Survey Patient Information Sheet
Positive Voices is a national survey of the lives, experiences, and health care needs of people
living with HIV in the United Kingdom. We are asking you to take part in the survey to help
improve health services, inform HIV policies, and identify the unmet needs of people with HIV.
Your answers will be kept strictly confidential and no-one looking at the study findings
will be able to identify you in any way.
This web study is being carried out by Public Health England (PHE) and University College
London (UCL) and is funded by National Institute for Health Research.
Your participation is voluntary, so take time to decide whether or not you wish to take part.
More information about the survey can be found online at www.hpa.org.uk/hiv/voices.
Thank you.
Positive Voices: the National Survey of People Living with HIV
Why have I been invited?
You have been randomly selected to complete the survey, as you are an adult living with HIV
and attended an NHS clinic in the past year. We invite you to share your unique experience and
contribute to the improvement of HIV prevention, treatment, and care services.
How do I take part?
You can read the questions and enter the answers online. The study asks some sensitive
questions. You can skip any questions you do not want to answer. You are also free to quit the
survey at any time.
The survey will take about 20 minutes to complete, but it may take less or more time for some
people. You may save your answers and return at another time. When you complete the survey,
click submit and close the browser window.
Will my answers be kept confidential and anonymous?
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Yes. The information you provide is totally confidential and handled in accordance with the Data
Protection Act 1998. Your answers are anonymous and will not allow you to be identified in any
way. Your doctors will not see your answers, and your response will not affect your care in
anyway.
The Unique Code provided on the survey invitation will be used to link your answers to your
clinical information, such as CD4 and viral load test results. We hope this will help us
understand how lifestyles and experiences may affect our health. The clinical information has
been unlinked from all personally identifying information and is completely anonymous.
For more information on Public Health England’s national HIV surveillance systems, go to:
http://www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/HIV/HIVSurveillance/
The survey responses are encrypted and the survey will not collect your IP address. The data
resides within a server with restricted access. When you complete the survey, the final page will
give instructions on how to turn off cookies and clear your browser history.
What do I do if I have questions or complaints about the survey?
If you are unhappy about any part of the survey, please share your concerns with the
researchers using the contact details below.
Meaghan Kall, Study Coordinator
Email: [email protected]
Phone: 02083277560
Mobile: 07879117272
If you wish to make a formal complaint you can call patient support services at Camden PCT on
020 3317 3003, or email [email protected].
FREE PHONE OPTION: You may opt to complete this survey via telephone. Please call or
SMS for a call back: 0800 XXX XXXX or 07879117272.
This research has been reviewed and approved by the London Harrow NHS Research Ethics
Committee (Project ID 13/LO/0279).
I have read the information, and wish to proceed to the survey
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Appendix 6 – Community Support Organisation Contact Sheet
Useful Contacts
For information and advice
NAM/Aidsmap
Comprehensive and accurate online and printed information and news about living with HIV and
HIV treatment
www.aidsmap.com
Terrence Higgins Trust
The largest HIV charity in the UK offering a wide range of HIV information and support services
THT Direct: 08451221200 Monday-Friday 10am-10pm, Saturday & Sunday 12pm-6pm
www.tht.org.uk
Naz Project London
Sexual health and HIV support services for Black and Minority Ethnic (BME) communities in
London
020 8741 1879
[email protected]
For emotional support…
Samaritans
Confidential emotional support 24 hours a day
www.samaritans.org.uk
Support by phone: 08457909090
Support by email: [email protected]
For relationship advice…
Relate
Offering advice, relationship counselling, therapy, and support face-to-face, by phone, and via
the website
Relate Direct: 08451304016 Monday-Friday 9am–6pm, Saturday 9am– 1pm
Face-to-face appointments: 08454561310
www.relate.org.uk
Email a counsellor service available through their website
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