Pilot of non-invasive (oral fluid) testing for HIV within a

community setting

Joseph Debattista* (1), Shaun Staunton (2), Frances Birrell (3), Nicole Roudenko (4), William Rutkin (5), Craig Davis (3)

Brisbane Sexual Health & AIDS Service, Northside Health Service District (1); Queensland Association for Healthy Communities (2),

Communicable Diseases Branch, Queensland Health (3), Division of Immunology, Queensland Health Pathology Services, Royal

Brisbane & Women’s Hospital (4), Toowoomba Health Service District (5), Queensland, Australia.

Background

This study set itself three objectives: • 1) Determine the prevalence of HIV amongst

MSM attending gay saunas and other recreational venues;

• 2) Determine the level of undiagnosed HIV infection within a community setting and;

• 3) Identify sexual risk behaviour associated with HIV positive and negative serostatus and compared with those individuals who unaware of their positive status.

Methods

• 427 MSM were recruited over a period of one week in various sex on premises venues (SOPV) and gay bars within the inner city of Brisbane.

• An additional 37 MSM were recruited over a 3 week period in a smaller, regional centre (Toowoomba).

Methods

• Oral fluid testing for HIV antibodies was undertaken using the Orasure collection system and assay.

• Each participant was invited to complete a brief behaviour questionnaire and submit an oral fluid specimen.

• Participants were also asked their HIV status.

Methods

• Surveys and specimens were linked using an anonymous numerical code.

• Surveys were analysed using Epi-Info. • Oral swabs were tested for the presence of HIV

antibodies and any reactive specimens were confirmed using an Orasure Western Blot.

• Confirmed serology results were linked to reported sexual behaviours, testing patterns and HIV status.

Results

• Of the 464 oral fluid specimens collected, 47 were reactive and 41 were confirmed positive by Western Blot (8.8%).

• Of the 464 men surveyed, 33 identified as HIV positive, and all of these were reactive by the Orasure assay (7.1%).

• Refusal rates amongst patrons varied from 28 to 41%.

Results

• 7 people who identified as negative serostatus and 1 who did not answer the question were confirmed as Orasure reactive ie. 1.9% (8/431) of those MSM who identified as negative or unknown serostatus.

• 19.5% (8/41) of the total confirmed HIV positive individuals were not aware of their true serostatus.

Results

• HIVpp: +ve self report / +ve test (33)

• HIVnn: -ve self report / -ve test (424)

• HIVnp: -ve self report / +ve test (8)

Age & Venue

Risk FactorHIVpp HIVnn HIVnp Total

n N % n N % n N % n N %

Number 33 465 7.1 424 465 91.2 8 465 1.7 465 100.0

median age 43.5 - - 35.0 - - 28.0 - - 36.8 - -

mean age 42.5 - - 36.4 - - 31.7 - - 35.6 - -

age range 22 - 60 - -18 -

84

- -22 -

44

- -17-

84

- -

SOPV 16 33 48.5 135 424 31.8 1 7 14.3 152 464 32.8

pub/club 17 33 51.5 289 424 68.2 6 7 85.7 312 464 67.2

•Attend SOPV: HIVpp > HIVnn > HIVnp

•Median age: HIVpp > HIVnn > HIVnp

Most Recent HIV Test

• HIVpp: 67% tested w/i last 6 months (?other bloods tests, recent Dx)• HIVnn: 50% tested w/i last 6 months• HIVnp all had test w/i last 2 years (86% w/i 6 months) -? recent acquisition

Risk FactorHIVpp HIVnn HIVnp Total

n N % n N % n N % n N %

Number 33 465 7.1 424 465 91.2 8 465 1.7 465   100.0

last test < 1week

2 33 6.1 10 370 2.7 0 7 0.0 12 410 2.9

last test < 1- 4 weeks

9 33 27.3 41 370 11.1 1 7 14.3 51 410 12.4

last test 1 - 6 months

10 33 30.3 142 370 38.4 5 7 71.4 157 410 38.3

last test 7 -12 months

1 33 3.0 64 370 17.3 0 7 0.0 65 410 15.9

last test 1 – 2 years

2 33 6.1 59 370 15.9 1 7 14.3 62 410 15.1

last test 2- 4 years

2 33 6.1 30 370 8.1 0 7 0.0 32 410 7.8

last test > 4 years

7 33 21.2 24 370 6.5 0 7 0.0 31 410 7.6

Number of Partners in last 6 months

• HIVpp: ~40% ≥ 11 partners• HIVnn: ~20% ≥ 11 partners• HIVnp: ~14% ≥ 11 partners

Risk FactorHIVpp HIVnn HIVnp Total

n N % n N % n N % n N %

Number 33 465 7.1 424 465 91.2 8 465 1.7 465   100.0

number ptnrs - none

1 32 3.1 31 414 7.5 0 7 0.0 32 453 7.1

number ptnrs - 1

5 32 15.6 79 414 19.1 1 7 14.3 85 453 18.8

number ptnrs - 2 to 5

7 32 21.9 139 414 33.6 3 7 42.9 149 453 32.9

number ptnrs - 6 to 10

6 32 18.8 77 414 18.6 2 7 28.6 85 453 18.8

number ptnrs - 11 to 50

7 32 21.9 75 414 18.1 1 7 14.3 83 453 18.3

number ptnrs >50

6 32 18.8 11 414 2.7 0 7 0.0 17 453 3.8

Unknown number of ptnrs

0 32 0.0 2 414 0.5 0 7 0.0 2 453 0.4

Unprotected Sex

• Regular partner– HIVpp < HIVnn < HIVnp

• Casual partner– HIVpp > HIVnn > HIVnp

Risk FactorHIVpp HIVnn HIVnp Total

n N % n N % n N % n N %

Number 33 465 7.1 424 465 91.2 8 465 1.7 465   100.0

unprotected sex with regular partner

10 31 32.3 154 383 40.2 3 7 42.9 167 420 39.8

unprotected sex with casual partner

13 32 40.6 97 412 23.5 1 7 14.3 111 451 24.6

Knowledge of Partner Status

• Don’t know status of regular partner – HIVpp < HIVnn < HIVnp

• Don’t’ know status of casual partner– (HIVpp ~HIVnp) < HIVnn

Risk FactorHIVpp HIVnn HIVnp Total

n N % n N % n N % n N %

Number 33 465 7.1 424 465 91.2 8 465 1.7 465   100.0

know ptnr status (reg) +ve

11 25 44.0 10 334 3.0 0 6 0.0 21 365 5.8

know ptnr status (reg) -ve

5 25 20.0 193 334 57.8 3 6 50.0 201 365 55.1

know ptnr status (reg) -unknown

9 25 36.0 131 334 39.2 3 6 50.0 143 365 39.2

know ptnr status (cas) +ve

8 27 29.6 9 286 3.1 0 5 0.0 17 318 5.3

know ptnr status (cas) -ve

3 27 11.1 92 286 32.2 2 5 40.0 97 318 30.5

know ptnr status (cas) - unknown

16 27 59.3 185 286 64.7 3 5 60.0 204 318 64.2

Informed Partner of Status

• Informed none of regular partners– HIVpp < HIVnn < HIVnp

• Informed none of casual partners– HIVpp < (HIVnn ~ HIVnp)

Risk FactorHIVpp HIVnn HIVnp Total

n N % n N % n N % n N %

Number 33 465 7.1 424 465 91.2 8 465 1.7 465   100.0

inform ptnr (reg)-all

15 30 50.0 133 390 34.1 3 7 42.9 151 427 35.4

inform ptnr (reg) - some

10 30 33.3 114 390 29.2 1 7 14.3 125 427 29.3

inform ptnr (reg) - none

5 30 16.7 143 390 36.7 3 7 42.9 151 427 35.4

inform ptnr (cas) - all

8 31 25.8 85 383 22.2 0 7 0.0 93 421 22.1

inform ptnr (cas) - some

17 31 54.8 127 383 33.2 4 7 57.1 148 421 35.2

inform ptnr (cas) - none

6 31 19.4 171 383 44.6 3 7 42.9 180 421 42.8

Risk Factors – HIVpp (vs HIVnn+HIVnp)

Risk Factor Odds Ratio 95% Confidence Intervals

p value

Attends SOPV 2.04 0.93 to 4.43 0.06

Unprotected sex with regular partner 0.71 0.29 to 1.62 0.38

Unprotected sex with casual partner 2.24 0.98 to 5.00 0.03

Knew HIV status of regular partner 25.93 8.28 to 79.70 0.00

Knew HIV status of casual partner 13.19 3.88 to 43.00 0.00

Informed regular partner of HIV status 2.91 1.06 to 9.92 0.03

Informed casual partner of HIV status 3.36 1.30 to 10.20 0.01

Had more than 11 partners in last six months

2.55 1.11 to 5.68 0.01

Results

• 11% of SOPV patrons were HIV+

• 5.5% of bar patrons were HIV+

• All unknown HIV+ were detected in bars (except respondent who didn’t answer).

• No variation across SOPVs

Results

• Outreach staff reported patrons to be very receptive to the study.

• The majority of refusals were from younger patrons (identified as late 20's to early 30's) and those who were present as "couples".

• The latter were conjectured to be reluctant to complete the survey/discuss sexual histories in front of a current partner.

• A large number of people reportedly declined to participate on the basis that they already knew they were positive, or stated that they already knew their status.

The Orasure collection system for oral fluid has been applied in other

community-based surveillance studies similar to ours.

• 1718 persons screened via urine samples in outreach settings. 12% (210) of the group were found to be HIV positive, of whom 80% (169) had never previously tested for HIV.

• One Orasure study of 1206 men recruited from gay venues in London detected 132 (10.9%) HIV infections. Of these, 32.5% had been previously undiagnosed and another 4.1% of participants reported an incorrect diagnosis.

• Another study of 1744 msm in gay bars in Glasgow and Edinburgh, Scotland found a HIV prevalence of 4.4%. 41.7% of positive men were undiagnosed- more than half had had a negative HIV result and thought they were negative.

ACKNOWLEDGEMENTS

We gratefully acknowledge the support of the laboratory staff of the Division of Immunology, QHPS who performed the assays, the staff and management of the participating clubs and Sex on Premises Venues, the outreach workers from the Queensland Association for Healthy Communities (QAHC) who collected the specimens and patron surveys (Greg Jenner, Ben Wilcock, Michael King, Angela Yin, Susan Gobbart, Jasmine Linton, Mark Herriman, David Deloso, Scott Norman), Gary Boddy of the Communicable Diseases Branch, and most importantly, patrons who generously participated. This study was funded by the Communicable Diseases Branch, Queensland Health.