This talk was presented at the 10th Annual Canadian Conference on HIV/AIDS Research in Toronto in June 2001.

Young gay and bisexual men's reactions to the introduction and implementation of point-of-care rapid HIV testing in Vancouver

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Mary Lou Miller*, Steve Martindale*, Nancy McLean**, Darrel Cook***, Linda Knowles***, Mike Rekart***, Daphne Spencer***.

* Vanguard Project, BC Centre for Excellence in HIV/AIDS, Vancouver, BC.
** VanVax Vaccine Trial, BC Centre for Excellence in HIV/AIDS, Vancouver, BC.
*** BC Centre for Disease Control, Vancouver, BC.

Hello. My name is Mary Lou Miller and I'm a research nurse for the Vanguard Project. I was involved in both phases of the clinical trial to test the accuracy and implications of BioChem's new rapid HIV test kit. Since the rapid point of care that was approved by Health Canada I have done 575 tests.

My colleague and co-author Steve Martindale and I did some of our own research to solicit feedback from the Vanguard participants on the issue of rapid testing. I'll be presenting the data that we collected directly from the participants, along with some of the data collected by the BC Centre for Disease Control specific to the Vanguard participants.

THE VANGUARD PROJECT:

• Ongoing study of HIV rates and risk factors in MSM
• 15 to 30 years of age at baseline
• No previous HIV-positive test result
• Reside in Greater Vancouver region at baseline
• Recruited through outreach, clinics and physicians
• Annual self-administered questionnaire
• HIV testing & stored blood sample
• Over 900 participants have completed baseline Q

Briefly, let me tell you about the Vanguard Project.

The Vanguard Project is an ongoing study of HIV rates and risk factors among young gay and bisexual men between the ages of 15 and 30 in the Lower Mainland. Participants complete annual self-administered questionnaires and provide blood samples for HIV testing and storage either annually or every 6 months. The study has now been running for six years, and so far nearly over 900 young men have completed baseline questionnaires.

OBJECTIVES:

• To assess the opinions of young gay and bisexual men on point-of-care rapid HIV testing
• To document the experience of young gay and bisexual men in participating in a two-phase clinical trial to test the Fast-Check HIV 1/2 test kits
• To determine if the opinions of young gay and bisexual men about rapid HIV testing have changed over time as a result of participation in the clinical trial

A year before the clinical trial began, Steve and I wanted to find out what young gay and bisexual men thought about the idea of rapid HIV testing.

Gay and bisexual men are primary consumers of HIV testing services, and the developing testing technologies are of particular interest to the gay community.

Once the clinical trial was underway, we wanted to be able to document the experience of our participants in the clinical trial, and had the advantage of being able to follow-up with our participants after the trial was over.

Most recently, we have tried to determine if their involvement with the clinical trial and their consequent familiarity with the rapid testing process has changed the opinions that Vanguard participants hold towards rapid HIV testing.

TIMELINE:

a) Advance e-mail survey:	Dec. 1997
b) Phase One of clinical trial:	1998/99
c) Phase Two of clinical trial:	Late 1999
d) Approved:	March 2000
e) Follow-up e-mail survey:	May 2000

Here's a quick time-line of the stages of the data collection we've done.

ADVANCE SURVEY: RESULTS

• Short survey e-mailed December 1997
• Sent to 159 participants: 66 (42%) responded

Here are the results of the Advance Survey that was done in late '97. This short, three-question survey was e-mailed to all Vanguard participants with active e-mail addresses, which at that time was 159 men. 42% of these responded.

82% of respondents felt that the introduction of rapid HIV testing was generally a good idea. Eight percent felt that it was a bad idea, and a sizeable minority were undecided.

Two-thirds of respondents expressed a willingness to participate in the first phase of the clinical trial, to test the accuracy of the rapid test kits. Note, however, that once the trial actually began a year later, over 90% of those who came into my office agreed to participate.

CLINICAL TRIAL: PHASE ONE

• 1998/99 in 4 cities across the country
• Objective: to test the accuracy of the rapid test
• Rapid test results not given to participants
  
• Vanguard site:
  • 336 participants invited to participate
  • 314 (93.5%) agreed to participate
  • 22 (6.5%) declined

The first phase of the clinical trial began in late 1998, to test the accuracy of the rapid test kits. The results of the clinical trial were presented by Mike Rekart at CAHR 2000. I'll focus instead on the response of the participants.

In this phase of the trial, the results of the rapid tests were not given to participants.

Over 300 Vanguard participants agreed to take part in this phase of the trial, representing over 90% of those invited to take part. The reasons given for declining were:

• 17 didn't like finger pricks
• 3 were too busy
• 1 wanted to be paid
• 1 couldn't be bothered
• 1 wanted the results right away
• 1 was too tired

CLINICAL TRIAL: PHASE TWO

• Late 1999 at 4 sites in Vancouver
• Objectives: to examine impact on patients & care providers and to establish counseling guidelines.
• Rapid test results were given to participants.
• Care providers' & participants' comments recorded.
  
• Vanguard site:
  • 100 participants were offered the rapid test.
  • 98 (98%) agreed to the rapid test
  • 2 (2%) chose the standard testing method

Late last year the second phase of the clinical trial took place, in which rapid results were given to participants, and comments were solicited from participants and health care providers in order to compile recommendations for amendments to pre- and post-test counselling guidelines.

In this phase of the trial, I offered the choice of rapid testing or standard testing to 100 participants, 98 of whom agreed to be tested using the rapid test.

Two Vanguard participants chose to be tested using the standard testing method:

1. Had they known before arriving at the clinic for testing that they could have received a rapid result that day, they would have brought a friend for support, and
2. A dislike of finger sticks.

PHASE TWO: PARTICIPANT RESPONSES

None of the participants who tested negative during the clinical trial requested further testing to confirm their HIV status. Since the rapid test was approved in March, however, I have had two participants who asked to be tested using both methods in order to verify the rapid result.

In this case, the test is confirmed within 24-38 hours from the British Columbia Center for Disease Control lab using Western Blot

In this phase of the clinical trial, 97% of the participants preferred the rapid test over the standard testing method, and 100% of them said they would choose rapid testing again.

Of the three who expressed a preference for the standard testing method:

• One participant found the rapid method scarier as it was more "condensed"
• and one participant thought the waiting period was of benefit as that gave him time to review his sexual practices.
  

FOLLOW-UP SURVEY:

• Short survey e-mailed May 2000 to 334 participants
• 100 (29.9%) responded; 44 (44%) had had a rapid test.

*2 missing values

Here are the results of the follow-up survey we e-mailed to Vanguard participants in May 2000.

60% of participants who'd had a rapid test found rapid testing to be less stressful than standard testing, and over 90% of participants who'd had a rapid test found the single counseling session to be sufficient, and not a single participant found the counseling to be insufficient.

92% of all participants who responded think that the introduction of rapid testing is a good idea.

Nearly 85% of all participants who responded would choose rapid testing in the future. Note that this includes many participants who've never had a rapid test.

FOLLOW-UP SURVEY:

*Fisher's Exact Test

Participants who've had a rapid test were slightly more likely than those who haven't had a rapid test to think that the introduction of rapid testing is a good idea, although the difference is not considered statistically significant.

Participants who've had a rapid test were much more likely than those who haven't had a rapid test to choose rapid testing next time (fully 98% compared to only 75%), and this difference is statistically significant.

POST-APPROVAL RESULTS:

• Out of 575 rapid tests between April 2000 and May 2001, a total of 8 HIV-reactive tests were confirmed by Western Blot.
• There have been a total of 19 HIV-reactive tests overall:
  • 5 HIV-reactives from Vanguard confirmed by Western Blot
  • 6 participants tested at other sites using standard method
  • 5 participants given standard test through testing on site
  • 2 others declined to join the Vanguard Project
  • 1 was ineligible as he had previously tested reactive
  • 1 participant with low risk behaviour tested reactive; whenre-tested was non-reactive and subsequent serum test wasnon-reactive

CONCLUSIONS:

• Rapid testing reduces stress for participants and care providers, and participants consider a single counseling session sufficient.
• Almost all participants who are familiar with the rapid test preferred it and would choose it over standard testing.
• Those who've had a rapid test are significantly more likely to choose it again in the future.

Rapid testing reduced stress for participants and care providers, and participants consider a single counseling session sufficient.

Almost all participants who are familiar with the rapid test preferred it and would choose it over standard testing.

Those who've had a rapid test are significantly more likelyto choose it again in the future.

CONCLUSIONS (cont'd):

• There is high demand among young gay and bisexual men for a reduction in the waiting period and consequently for the introduction of point-of care rapid HIV screening.
• The majority of young gay and bisexual men are supportive of the introduction of rapid HIV testing.

In conclusion:

There is high demand among young gay and bisexual men fora reduction in the waiting period and consequently for the introduction of point-of-care rapid HIV screening.

The majority of young gay and bisexual men in Vancouverare supportive of the introduction of rapid HIV testing

ACKNOWLEDGEMENTS:

• Vanguard participants
• BC Centre for Excellence in HIV/AIDS
• Three Bridges Community Health Centre
• BC Centre for Disease Control
• BioChem ImmunoSystems Inc.