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The annual number of new human immunodeficiency virus (HIV) infections in the United Kingdom among men who have sex with men (MSM) has risen, and remains high among heterosexuals. Increasing HIV transmission among MSM is consistent with evidence of ongoing sexual risk behavior in this group, and targeted prevention strategies are needed for those at risk of acquiring HIV.
The Attitudes to and Understanding of Risk of Acquisition of HIV (AURAH) study was designed to collect information on HIV negative adults at risk of HIV infection in the United Kingdom, based on the following parameters: physical and mental health, lifestyle, patterns of sexual behaviour, and attitudes to sexual risk.
Cross-sectional questionnaire study of HIV negative or undiagnosed sexual health clinic attendees in the United Kingdom from 2013-2014.
Of 2630 participants in the AURAH study, 2064 (78%) were in the key subgroups of interest; 580 were black Africans (325 females and 255 males) and 1484 were MSM, with 27 participants belonging to both categories.
The results from AURAH will be a significant resource to understand the attitudes and sexual behaviour of those at risk of acquiring HIV within the United Kingdom. AURAH will inform future prevention efforts and targeted health promotion initiatives in the HIV negative population.
During 2013, 6000 people were newly diagnosed with human immunodeficiency virus (HIV) in the United Kingdom (UK), and the estimated number of people living with HIV in the United Kingdom was 107,800 by the end of that year [
An estimated 38,700 black Africans were living with HIV in the United Kingdom in 2013. Despite a decline in new diagnoses among people born in sub-Saharan Africa, black Africans form the second largest social group affected by HIV in the United Kingdom [
Evidence of ongoing, and likely increasing, HIV transmission among MSM [
Sexual transmission risk arises as a result of perceptions and behaviors which may differ depending on the HIV serostatus of individuals. Strategies aimed at reduction of HIV transmission need to address differences in both HIV positive and negative individuals’ perceptions, choices, and behaviors [
Current data from the United Kingdom that inform on these themes from the perspective of HIV negative MSM and black Africans are limited. In particular, information is needed on HIV testing behavior and preferences, patterns of sexual behavior, prevalence of specific types of condomless sex (to capture potential risk reduction strategies), attitudes to condomless sex with individuals of known and unknown HIV status, and associations with factors such as mental/general health, STI history, and alcohol and drug use. Data from the Attitudes to and Understanding of Risk of Acquisition of HIV (AURAH) study will contribute to an understanding of how knowledge of ART and detectable/undetectable VLs among HIV negative individuals may affect attitudes and perceptions which lead to condomless sex with partners of unknown and/or known HIV status in the United Kingdom.
Uptake and frequency of HIV testing among MSM in the United Kingdom remains inadequate (an estimated 25% never tested [
The AURAH study will allow comparison of HIV negative or undiagnosed MSM and black Africans with HIV positive participants from the Antiretrovirals, Sexual Transmission Risk and Attitudes (ASTRA) study [
This paper describes key aspects underlying the AURAH study, including its rationale, design, methods and response rates. A description of the participant characteristics is also outlined. Details of both response rates and participant characteristics may be of use in the comparison to other studies set in sexual health clinics or outpatient settings, and inform future design and planning of subsequent studies. Further publications will address detailed research questions based on the data collected from the participants in the AURAH study.
The primary aim of the AURAH study was to assess patterns of sexual behavior, and attitudes to sexual risk, among HIV negative adults at risk of HIV infection, and to investigate associations with demographic, socio-economic, health, and lifestyle factors.
The detailed objectives of the AURAH study were to assess the following in HIV negative (not known to be HIV positive) sexual health clinic attendees:
Levels of recent condomless vaginal or anal sex according to demographic groups (sexuality, ethnicity).
Among those who have had condomless sex, the distribution of: number of sexual partners, type of partners, knowledge of HIV status of partners, number of times had condomless sex, type of condomless sex, and reasons for not using condom.
Among those having condomless sex with partners of positive or unknown HIV serostatus, the prevalence of risk-reduction measures such as seropositioning.
The prevalence of psychological and physical symptoms (ie, depression, anxiety) and lifestyle factors (ie, drug and alcohol use), and whether demographic/social factors, psychological and physical symptoms, quality of life, and lifestyle factors are associated with condomless sex.
Beliefs regarding the effect of ART in HIV positive individuals, and undetectable VL, on HIV transmission risk (transmission risk beliefs) and the association of such beliefs with sexual behavior.
History of any HIV testing and attitudes to HIV and HIV medications, including awareness of, and any history of, taking post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP).
Attitudes towards testing for HIV in different settings (ie, sexual health clinic, general practitioner, community based testing), type of testing (ie, self-sampling, self-testing) and preferred sample type for HIV self-testing (ie, saliva based or finger-prick sample of blood).
AURAH was a cross-sectional self-administered questionnaire study in individuals attending 20 sexual health (Genito-Urinary Medicine) clinics, in 15 clinical centers (National Health Service trusts), across the United Kingdom. The recruitment period was 17 months, commencing June 2013.
AURAH was conducted among individuals attending sexual health clinics for routine STI and/or HIV testing. The inclusion criteria were as follows: HIV negative (or undiagnosed) subjects aged 18 years or over, attending for routine STI or HIV testing in sexual health clinics. Individuals not known to be HIV positive at the time of recruitment to AURAH, but testing positive on that (or a subsequent) clinic visit were retained in the AURAH sample.
The 20 clinical centers were situated across England, and details of the locations and clinics are listed in the Acknowledgements section. The sites were selected on the understanding that they could provide access to large numbers of HIV negative patients attending clinics for STI screening and HIV testing, including the key demographic
The AURAH study adopted a recruitment target of 2000 total sample size, of which 1000 would be MSM, and 1000 heterosexuals, of whom 600 would be black African. After calculations the study would have sufficient power to:
Ascertain the proportion of individuals who report that they have had condomless sex in the past 3 months with a partner of unknown or positive HIV status and that one of the reasons for this was “
Ascertain the proportion of individuals who report that they have had condomless sex in the past 3 months with a positive partner who gave a reason as “
Compare the prevalence of depression on the Patient Health Questionnaire (PHQ-9) scale [
For objectives (1) and (2), the planned sample size of 1000 MSM would allow estimation of a 5% prevalence (95% CI 3.65-6.35), a 10% prevalence (95% CI 8.65-11.35), and a 20% prevalence (95% CI 17.52-22.48). For the planned sample size of approximately 300 black African men (or women), prevalences of 5% (95% CI 2.55-7.45), 10% (95% CI 6.60-13.4) and 20% (95% CI 15.47-24.53) would be estimated.
For objective (3), given approximately 2250 MSM, 200 black African men and 450 black African women in the ASTRA sample [
Recruitment to the study took place between June 2013 and November 2014 during different periods at the 20 clinics. A flowchart of recruitment procedures for the study is included (see
Initial recruitment in the clinics was not restricted. Each site identified specific clinics each week, at which subjects were recruited, aiming to ensure a reasonably representative study population. Consecutive subjects attending each clinic were identified, approached, and invited to take part. It was more feasible to initially recruit in this unrestricted way, and the intent was to modify recruitment strategy as necessary to recruit a sufficient number of MSM and black Africans. After 6 months of unrestricted recruiting, targeted recruitment was implemented across all study sites, and clinic staff were asked to identify and recruit only MSM or those of black ethnicity. Once the recruitment target of 1000 MSM had been met (11 months into the study), 15 clinics were asked to concentrate on recruiting only those known to have specifically black African ethnicity before finishing recruitment, and the 5 sites that had recruited the largest number of MSM continued with sole recruitment of MSM to increase the power for some research questions.
Flowchart of AURAH clinic recruitment.
All subjects who were invited to participate were given an information sheet about the study. Those who agreed to complete the questionnaire were asked to sign a consent form. The form included an optional section for participants to provide details to allow contact regarding study reminders and, in the future, to invite participants to join future research studies. Participants were informed that consent to be contacted was optional but that those who provided contact details would be entered into a monthly draw offering a prize of £100 of shopping vouchers. Participants who agreed to be contacted were asked for their preferred contact details (email address and mobile phone number for short message service contact). The consent form noted that participants’ contact details would only be used for these purposes and would be held securely at the study management center as part of the study records, but would be deleted after a period of two years. During the consent process, it was reiterated that the study was for HIV negative or undiagnosed individuals only. Participants were told that the questionnaire would take between 15 and 30 minutes to complete and were given an envelope to seal it in, so that their answers were not available to clinic staff. There was an option for participants to take the questionnaire off-site for completion, and postage paid envelopes were provided to return the questionnaire directly to the study management center if required. The option of taking the questionnaire off-site was aimed at including participants who did not have time to complete the questionnaire before they were called for their clinic appointment. Participants were encouraged to complete the questionnaire on-site if possible, to minimize non-return of questionnaires by consented participants.
Participants were made aware that their participation included supplying information on the results of any STI or HIV tests that took place in the clinic on the day they were enrolled in to the study. The study log was used to record whether any HIV or STI tests were undertaken and to record the result of any HIV test (negative/positive) performed on the day of enrolment.
Completed questionnaires were collected in the clinic and transferred regularly to the study management center. Questionnaires were identified only by a unique study number. Participants were instructed not to write their name or clinic number on the questionnaire to maintain their anonymity.
Details of all clinic attendees approached for the study were collected in a study log maintained securely and updated daily at each clinical site. The study log contained study numbers, clinic identifiers and details of consent status for all patients invited to participate in the study, whether or not HIV and other STI tests had been done, and the result of any HIV test. Contact details of participants were also entered in the log if participants consented to being contacted about future research. Selected information from the study log at each clinical center was securely transferred on a regular basis to the study management center. At the study management center, contact details for future research were kept securely and separately from the questionnaire data.
Regular reports were sent from the study management center to each site during the recruitment period, detailing trends and overall progress in recruitment for each of the study sites. In addition, regular checks were made on the completeness and quality of the study log and its concordance with received questionnaires.
Questionnaires received at the management center were digitized by an external data processing contractor. Each paper questionnaire was checked for legibility, digitally scanned, and the resulting images were used as the source for two manual data entry rounds with subsequent quality checking. The completed data entry batches delivered by the contractor were checked for accuracy at the study management center by fully examining a 5% sample.
The original pseudonymized study datasets, including scanned images of the questionnaires, were stored at the study management center in encrypted digital form. They were preserved by being duplicated and stored on managed servers with regular backup and professional administration. The original paper questionnaires were stored securely in locked cabinets. The study datasets will be made freely and readily available to the research community after a suitable interval in a form that ensures that participant anonymity and confidentiality is maintained.
The questionnaire was based on the design of the ASTRA study questionnaire, a cross sectional study that took place among HIV positive participants attending outpatient HIV clinics across the United Kingdom in 2011-2012 [
The final questionnaire consisted of a printed A5 booklet, with versions for men (24-page questionnaire) and women (20-page questionnaire). The pilot study indicated that the questionnaire took roughly 20-25 minutes to complete. The questionnaire sought detailed information on the following factors:
The research protocol and all versions of the study documents for the AURAH study (information sheet, consent form, questionnaires and insert) were approved by the designated Research Ethics Committees (REC) (National Research Ethics Service committee London-Hampstead, ref: 13/LO/0246). Based on these documents, the study subsequently received permission for clinical research at all participating National Health Service (NHS) sites from local Research & Development (R&D). The REC (NRES committee London-Hampstead) further approved the protocol and study documents for the AURAH2 study in December 2014 (REC ref: 14/LO/1881) and subsequent permission by local R&D for clinical research at the three NHS clinic sites in March 2015.
The study was managed on a day-to-day basis by a core group of five staff at the study management center: the HIV Epidemiology and Biostatistics Group, Research Department of Infection and Population Health, Royal Free Campus, University College London.
An advisory group was also established at the start of the study to provide guidance and support. The advisory group consisted of representatives from University College London, HIV i-Base, the London School of Hygiene and Tropical Medicine and City University London.
Over the 17-month study period a total of 4393 eligible patients were approached and asked to participate in this study. Of those approached, 3340 (76.03%) gave consent to take part in the study. The number of completed questionnaires finally collected was 2630 and thus the response rate was 59.87% (2630/4393) of eligible patients approached, and 78.74% (2630/3340) of those who gave consent. The majority of respondents (1432/2630, 54.44%) agreed to provide their contact details for participation in future research.
Eighteen of the 20 participating clinics were able to provide estimates of the number of outpatients seen in all clinical sessions over the same period, and the numbers of these in the key groups (MSM and black Africans). More than 288,090 patients were found to have attended these 18 clinics at some point during the respective recruitment periods. Of the combined total attending the clinics, it was estimated that approximately 7.6% were black African and 13.6% were MSM.
The mean age (of the 2630 participants who supplied details) at the time of questionnaire completion was 32 years (SD 10, range 18-80 years). Overall, 1954 (74.30%) participants were men and 676 (25.70%) were women. Of the 1939 male participants whose sexuality was known, 1484 (76.53%) self-classified as MSM and 455 (23.47%) as heterosexual. Of the 1484 MSM participants, 965 (65.03%) agreed to provide their contact details for participation in future research, whereas only 36.92% (168/455) of heterosexual males and 43.20% (292/676) of females agreed to provide these details.
In terms of ethnic origin, 1505 of the 2630 (57.22%) participants self-classified as white, 580 participants (22.05%) as black African ethnicity, 249 (9.47%) as other black ethnicity, 264 (10.04%) as other ethnicity, and ethnic status was missing for 32 (1.22%). Of 548 people of black African ethnicity, 323 (58.9%) were female and 225 (41.1%) were male. Of 250 men of black African ethnicity whose sexuality was known, 30 (12.0%) self-classified as MSM and 220 (88.0%) as heterosexual. Of the 580 participants of black African ethnicity, 213 (36.7%) agreed to provide contact details for participation in future research.
Overall, 2535 of the 3340 consenting participants (75.90%) took an HIV test on the day they were approached in clinic. Of those tested, 18 of 2535 (0.71%) received a positive result that they were unaware of at the time. Of these 18 participants, nine returned completed questionnaires (these are retained in the AURAH sample). All nine of these cases were male, of which five were MSM and four were black heterosexuals. Clinics reported that 2624 of the 3340 consenting (78.56%) also tested for STIs on the day, although information on the nature of each test and the results were not collected for this study.
The characteristics of those recruited at the 20 clinical centers in terms of gender, sexual orientation, relevant ethnic status and testing are detailed in
Recruitment results for the 20 AURAH study clinical centers, 2013-2014.
Site | Length of study period in days | Individual patients attending during recruitment period | Eligible patients approached | Patients consenting (as % of approached = consent rate) | Patients responding = completed questionnaires received (as % of approached = response rate) |
Barking | 335 | 3475 | 64 | 59 (92%) | 34 (53%) |
Barts | 31 | a | 16 | 13 (81%) | 11 (69%) |
Birmingham | 127 | a | 53 | 49 (92%) | 33 (62%) |
Brighton | 482 | 13918c | 243 | 240 (99%) | 227 (93%) |
Bristol | 312 | 1021 | 59 | 58 (98%) | 55 (93%) |
Calderdale & Huddersfield | 428 | 13662 | 92 | 82 (89%) | 73 (79%) |
Coventry | 337 | 11218 | 269b | 256 (95%) | 246 (91%) |
Dean Street | 473 | 51882d | 1384 | 895 (65%) | 604 (44%) |
Homerton | 300 | 25312 | 159 | 149 (94%) | 123 (77%) |
John Hunter | 450 | 20236d | 235 | 131 (56%) | 84 (36%) |
Kings | 283 | 15500 | 305 | 204 (67%) | 168 (55%) |
Leicester | 84 | 5173 | 69 | 66 (96%) | 48 (70%) |
Mortimer Market | 332 | 13652e | 382 | 370 (97%) | 313 (82%) |
Newham | 320 | 9203 | 168 | 119 (71%) | 113 (67%) |
Reading | 405 | 14807 | 82 | 75 (91%) | 75 (91%) |
Royal Free | 416 | 33216 | 137 | 126 (92%) | 101 (74%) |
St George's | 333 | 17041 | 110 | 90 (82%) | 81 (74%) |
The London | 247 | 13747 | 40 | 35 (88%) | 33 (83%) |
WLCSH | 463 | 19094d | 462 | 270 (58%) | 164 (35%) |
Whipps Cross | 314 | 5933 | 64 | 53 (83%) | 44 (69%) |
TOTALS | - | 288090 | 4393 | 3340 (76%) | 2630 (60%) |
aClinic unable to supply data on total clinic attendance
bClinic was unable to supply data about those declining to participate – value derived from 95% consent rate estimated by the clinic
cCovers 75% of the recruitment period only
dCovers 90% of the recruitment period only
eCovers 55% of the recruitment period only
Site label | Men (as % of questionnaires received) | MSM (as % of questionnaires received) | Black African men (as % of questionnaires received) | Women (as % of questionnaires received) | Black African women (as % of questionnaires received) | Tested for HIV on the day (as % of consenting) | STI test on the day (as % of consenting) |
Barking | 25 (74%) | 8 (24%) | 16 (47%) | 9 (26%) | 9 (26%) | 43 (73%) | 49 (83%) |
Barts | 11 (100%) | 11 (100%) | 0 (0%) | 0 (0%) | 0 (0%) | 13 (100%) | 13 (100%) |
Birmingham | 11 (33%) | 7 (21%) | 0 (0%) | 22 (67%) | 3 (9%) | 40 (82%) | 49 (100%) |
Brighton | 207 (91%) | 197 (87%) | 5 (2%) | 20 (9%) | 9 (4%) | 170 (71%) | 185 (77%) |
Bristol | 51 (93%) | 44 (80%) | 2 (4%) | 4 (7%) | 3 (5%) | 55 (95%) | 38 (66%) |
Calderdale & Huddersfield | 55 (75%) | 47 (64%) | 6 (8%) | 18 (25%) | 11 (15%) | 69 (84%) | 71 (87%) |
Coventry | 104 (42%) | 34 (14%) | 57 (23%) | 142 (58%) | 105 (43%) | 124 (48%) | 161 (63%) |
Dean Street | 585 (97%) | 528 (87%) | 14 (2%) | 19 (3%) | 7 (1%) | 762 (85%) | 618 (69%) |
Homerton | 70 (57%) | 37 (30%) | 8 (7%) | 53 (43%) | 19 (15%) | 88 (59%) | 122 (82%) |
John Hunter | 69 (82%) | 49 (58%) | 4 (5%) | 15 (18%) | 1 (1%) | 94 (72%) | 98 (75%) |
Kings | 65 (39%) | 31 (18%) | 13 (8%) | 103 (61%) | 25 (15%) | 136 (67%) | 164 (80%) |
Leicester | 14 (30%) | 8 (17%) | 2 (4%) | 34 (71%) | 11 (23%) | 50 (76%) | 54 (82%) |
Mortimer Market | 303 (97%) | 266 (85%) | 28 (9%) | 10 (3%) | 7 (2%) | 323 (87%) | 328 (89%) |
Newham | 61 (54%) | 7 (6%) | 50 (44%) | 52 (46%) | 41 (36%) | 98 (82%) | 113 (95%) |
Reading | 50 (67%) | 35 (47%) | 8 (11%) | 25 (33%) | 16 (21%) | 64 (85%) | 68 (91%) |
Royal Free | 41 (41%) | 29 (29%) | 6 (6%) | 60 (59%) | 16 (16%) | 98 (78%) | 116 (92%) |
St George's | 56 (69%) | 36 (44%) | 10 (12%) | 25 (31%) | 7 (9%) | 65 (72%) | 82 (91%) |
The London | 17 (52%) | 10 (30%) | 5 (15%) | 16 (48%) | 14 (42%) | 26 (74%) | 35 (100%) |
WLCSH | 134 (82%) | 92 (56%) | 7 (4%) | 30 (18%) | 3 (2%) | 169 (63%) | 210 (78%) |
Whipps Cross | 25 (57%) | 8 (18%) | 14 (32%) | 19 (43%) | 18 (41%) | 48 (91%) | 50 (94%) |
TOTALS | 1954 (74%) | 1484 (56%) | 255 (10%) | 676 (26%) | 325 (12%) | 2535 (76%) | 2624 (79%) |
The AURAH study recruited 2630 participants from 20 UK sexual health clinics during 2013-2014. The initial rate for consent (2630/3340, 78.74%) was relatively high in this study, and the overall response rate (questionnaires received) was 59.87% (2630/4393) of eligible patients approached. However, there was considerable variation between the clinics in the response rate achieved (ranging from 35% to 93%). The difference in response rates between the clinics could be due to a number of reasons. When researchers at the sites with low response rates were asked about potential barriers to participation they noted education and literacy levels, level of English fluency, and the perceived amount of time that the study questionnaire would take to complete, among clinic attendees at their sites. It was felt that the monthly prize draw had not had a significant effect as an incentive to participate but potentially a smaller cash sum might have, however the study did not seek ethical approval for this due to time restraints.
The intention of this study was also to recruit large numbers within the key demographic sub-groups most affected by HIV in the United Kingdom, namely MSM and black African men and women. The study succeeded in this aim, and there were 2034 individuals in these groups of interest: 1484 MSM participants and 580 black African participants, with 30 individuals (1.47%) falling into both of these categories.
It is difficult to compare the overall study response rate with other studies of HIV negative MSM, as many Internet or venue-based studies have no records of numbers not agreeing to participate, and therefore response rate cannot be calculated. Our response rate is comparable with other surveys taking place outside the clinical context that have investigated sexual behavior (70% [
The average age of AURAH study participants was 32 years and, as expected, this was much younger than the average (45 years) of the ASTRA (HIV diagnosed) study participants [
The study population was not a random sample of those attending the clinics, as targeted recruitment was implemented after 6 months of recruitment. It should be noted that the target number for MSM recruitment (1000) was exceeded and that the target was reached early in the study. Recruitment was continued because it was desirable to increase power for some research questions. The number of black Africans recruited was 548, however this took a long time to achieve and required selective recruitment in 15 centers. A similar pattern of relative difficulty of recruitment in these two respective populations was observed in the ASTRA study (on HIV diagnosed individuals) [
The number of study participants diagnosed as HIV positive in-clinic during this study was 18 (0.71%, 95% CI 0.38-1.04, of 2535 consenting and tested). The selective nature of our sampling means this is not a meaningful prevalence estimate but, as might be expected in those attending sexual health clinics, this is very much higher than the general UK population HIV estimate for undiagnosed HIV of 0.07% [
In summary, the AURAH study includes a substantive but selective sample of those considered to be at risk of being infected with HIV in the United Kingdom. AURAH will give insights into the relationships between socio-demographic factors, physical and psychological symptoms, lifestyle factors, health-related quality of life, and sexual behavior in this population.
The results of the AURAH study will be relevant for understanding the process of HIV transmission within the United Kingdom, and for targeting of national prevention efforts. The data from AURAH will contribute to understanding the social, psychological and health-related factors that are linked to high risk sexual and HIV-testing behaviors, and therefore to ongoing transmission of HIV in the two most
antiretroviral treatment
Antiretrovirals, Sexual Transmission Risk and Attitudes
Attitudes to and Understanding of Risk of Acquisition of HIV
human immunodeficiency virus
men who have sex with men
National Health Service
National Research Ethics Service
post-exposure prophylaxis
Patient Health Questionnaire
pre-exposure prophylaxis
Research and Development
Research Ethics Committee
sexually transmitted infection
United Kingdom
viral load
We would like to thank all the study participants for their time and effort. We gratefully acknowledge the 20 participating sites and the contributions and efforts of the following at each site:
Design and data collection: JS, AS, AP, FL, RG, DA, NN, CS, SD, MF, AC, JA, R O’C, ML, VA, RD, MG, PF, SA, SM, JD, AT, DI, TS, ST, LS, GH, SC, AJ, AM, JE, AR. Analysis and interpretation: JS, AS, AP, FL, AR. Drafting the manuscript: JS, AS, AP, FL, AR.
AJ is the Governor of the Wellcome Trust.
Funding and support: The AURAH study presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (PGfAR RP-PG-0608-10142). The AURAH Study Group acknowledges the support of the NIHR, through the Comprehensive Clinical Research Network. The views expressed in this presentation are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health.