FDA advisory committee to review OTC availability of HIV test in May
- there are 4 articles in this report: the first, the news of the FDA hearing, articles 2 & 3 discuss the reality of HIV home-testing & a published study asking people how they would use it casually/with hook-ups etc; and 4th is a CDC report on unusual testing initiatives|
April 5, 2012 | By Michael Johnsen
BETHLEHEM, Pa. - OraSure Technologies on Wednesday announced that the Food and Drug Administration's Blood Products Advisory Committee will consider making its OraQuick Rapid HIV-1/2 test available over the counter on May 15.
At the meeting, OraSure will present its consumer-usage studies - approximately 5,800 subjects were enrolled and tested in this phase across 20 states, the company said, which helped identify more than 100 previously undiagnosed individuals.
"There is an urgent need for additional testing options to identify individuals who are HIV- positive, link them to care and reduce transmission of the virus," OraSure president and CEO Douglas Michels said. "Our belief is that the availability of an easy-to-use, accurate in-home HIV test will enable more people to learn their presumptive HIV status so that they can receive necessary care and support."
According to the Centers for Disease Control and Prevention, there are approximately 1.2 million people in the United States who have HIV and despite current HIV testing options, approximately 240,000 of them are unaware of their status. It is estimated that those undiagnosed are responsible for up to 70% of the approximately 50,000 new HIV infections occurring each year in the United States. The CDC recommends all people ages 13 to 64 years be offered an HIV test in healthcare settings, with more frequent testing for people at higher risk.
Citing clinical studies conducted by OraSure, the CDC noted the OraQuick oral fluid test correctly identified 99.3% of people who were infected with HIV (sensitivity) and 99.8% of people who were not infected with HIV (specificity). The Food and Drug Administration expects clinical laboratories will obtain similar results.
The OraQuick rapid HIV test for use with blood was waived under the Clinical Laboratory Improvements Amendments of 1988 in January 2003, and waived for use with oral fluid in June 2004. A waived test can be used in any facility with a CLIA certificate, rather than only in traditional laboratories. As such, a waived test can be used in many non-clinical settings.
Such was the case last summer when Walgreens teamed with Greater Than AIDS on a national awareness campaign around HIV/AIDS in the United States, to distribute informational resources and specialized HIV-related services at more than 300 Walgreens pharmacies in affected communities.
At these specialized pharmacy locations, Walgreens had pharmacists on hand to offer one-on-one medication counseling and other support services that provide customers living with HIV/AIDS and their families with compassionate, confidential care. Free rapid oral HIV testing was available at select Walgreens with technical support and guidance from the Centers for Disease Control and Prevention and test kits from OraSure Technologies.
State and local health departments and community-based organizations in the local markets conducted the tests and providing pre- and post-test counseling.
That means this could be the first switch application (from Jules: does this refer to switch to opt-out? I dont know) that could significantly benefit from a pharmacist or nurse practitioner intervention in the wake of last month's FDA public meeting on expanding the switch paradigm. One of the concerns associated with an OTC HIV test is the availability of counseling following a positive/false positive result. The OraQuick Rapid HIV point-of-care test produces results in 20 minutes - and if that 20 minutes transpires in a pharmacist or nurse clinician consultation room a person finding out that they are HIV positive would have immediate access to a healthcare professional.
To review the OraQuick Advance package insert, a product presently available to clinicians, click here.
Coming soon: over-the-counter oral AIDS test
FDA weighs retail sales of cheap, quick HIV test by Pennsylvania firm. Easy access could be positive for public health, but researchers at Columbia identify possible negative impacts on behavior.
By Gale Scott
February 1, 2012
Safe sex could get safer.
With HIV infection remaining a major health concern in New York City, many public health researchers are clamoring for an over-the-counter oral test for the virus. The thinking is that a home kit would let people test themselves, or to insist that partners or potential partners take and pass the test as a condition of having unprotected sex.
That test could arrive soon, if the FDA rules favorably on an application from OraSure Technologies. The Bethlehem, Penn., company has asked permission to have its OraQuick rapid HIV test approved for retail sale-much like a home pregnancy test. The product is widely used in clinical settings and is expected to sell for around $20 if approved.
Though many companies sell rapid HIV tests, OraSure is the only one that sells both blood and oral tests. Six others sell blood tests. "Our market share is 70% to 80% in public health and 50% to 60% in hospitals. We are the market leader" said OraSure CEO Douglas Michels.
FDA approval could come this year, ending a process that started when the company approached the FDA in 2004 with market research that showed a $500 million potential U.S. sales-demand for a home test. The company submitted its final module of clinical tests results to the FDA in last month.
Physically, the process would be simple: wipe a swab inside the mouth, dip it into a container, wait 20 minutes. One line means HIV negative, two lines means it is positive. In terms of manners however, it would be anything but simple, according to a study by Columbia University researchers published Wednesday.
Alex Carballo-Dieguez, Timothy Frasca and colleagues at the HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute recruited subjects from a high-risk group, men who have sex with men. Though the HIV test would be marketed to heterosexuals as well, the researchers chose homosexual and bisexual men because the virus is spreading more quickly in that demographic. Of 3,481 new HIV diagnoses in New York City in 2010, 52.1% were among these men, versus 47.4% in 2009, according to the New York City Department of Health and Mental Hygiene.
In the Columbia study, researchers offered these men the OraQuick test in their office and then interviewed them about their attitudes toward using it.
Most-over 80% of the men-said they would use the kit to test sexual partners or themselves if it became available over the counter.
But there was little agreement on how to broach the subject with a partner, how to handle an unexpected positive result, or deal with other situations. "The most surprising thing was how people would use it," said Mr. Carballo-Dieguez, "Some people said they would use it with casual partners, others said they would want there to be familiarity, and would use it only with their main partner."
The study, published in the Journal of Sex Research, included remarks and explanations from the test subjects, identified only by age and ethnicity.
Asked how they would bring up the topic of taking the test, some said they would be blunt and direct. The study quoted a Latino man, age 25, as planning to say, "Well, I'm interested in sexual health, well-being; would you mind taking this, you know, with me?" Another said he would use persuasion, talking up the uniqueness of the test and "how great it is." Others said they would make the test a condition of forgoing condom use or as a sign that a relationship had moved to steady from casual status.
Most saw a common problem in using the test with casual partners in spontaneous situations. "To wait 20 minutes to see what would happen would put the brakes on whatever crescendo you're having," said a 40-year-old white man. "It's a buzz killer."
A more serious concern, one raised by the test's opponents, is how users would react to a positive test. "There's a lot of potential opposition and clinics might not be crazy about direct access in a private setting with no personnel with them if they get a positive result," said Mr. Carballo-Dieguez.
OraSure's Mr. Michels said he had heard those concerns, but felt they were not an obstacle.
"Those objections have been raised and discussed, there has been an opportunity for public comment, but there is broad support for this test."
Mr. Frasca added, "There has been a progressive loosening of restrictions on HIV testing," and that many people feel the FDA will approve the application.
In announcing its latest FDA submission, OraSure cited federal Centers for Disease Control and Prevention statistics on the need to expand testing. There are approximately 1.2 million people in the U.S. who have HIV and about 240,000 are unaware of their status, according to the company.
Meanwhile, the test subjects had different ideas on the best strategy for dealing with a positive test. Some said they would offer deep sympathy and ask how to help. A minority said they'd be out the door. "Man, got to go," said a 21-year-old black man describing his likely reaction.
The researchers are now following up with a second study in which they have distributed tests for home use and will later ask subjects to report on their experiences using them. So far they have not studied the heterosexual population, but said it could have widespread use. They could even see a scenario-remote-in which a person could test a partner surreptitiously. "It's come up; I guess you could swab someone when they were sleeping, but it would very difficult," said Mr. Carballo-Dieguez.
Journal of Sex Research
Will Gay and Bisexually Active Men at High Risk of Infection Use
Over-the-Counter Rapid HIV Tests to Screen Sexual Partners? - pdf attached
The Food and Drug Administration may license OraQuick™, a rapid HIV test, for over-the-counter (OTC) sale. This study investigated whether HIV-uninfected, non-monogamous, gay and bisexual men who never or rarely use condoms would use the test with partners as a harm-reduction approach. Sixty participants responded to two computer-assisted self-interviews, underwent an in-depth interview, and chose whether to test themselves with OraQuick. Over 80% of the men said they would use the kit to test sexual partners or themselves if it became available OTC. Most participants understood that antibody tests have a window period in which the virus is undetectable, yet saw advantages to using the test to screen partners; 74% tested themselves in our offices. Participants offered several possible strategies to introduce the home-test idea to partners, frequently endorsed mutual testing, and highlighted that home testing could stimulate greater honesty in serostatus disclosure. Participants drew distinctions between testing regular versus occasional partners. Non-monogamous men who have sex with men, who never or rarely use condoms, may nevertheless seek to avoid HIV. Technologies that do not interfere with sexual pleasure are likely to be used when available. Studies are needed to evaluate the advantages and disadvantages of using OTC rapid HIV tests as one additional harm-reduction tool.
Early in the AIDS epidemic in the United States, HIV testing was voluntary, conducted in clinics, and required written consent and pre- and posttest counseling (Centers for Disease Control [CDC], 1987). These conditions have progressively changed. In 2006, the CDC recommended routine testing for patients and pregnant women in all health care settings unless they opted out of HIV screening; written consent and prevention counseling were no longer required (Branson et al., 2006). Furthermore, HIV tests became available that allowed specimen collection at home with results provided later at a clinic or over the phone, and these options were no longer as controversial as before (Branson, 1998). Researchers believed that home testing (HT) could be valuable "in empowering individuals to manage their HIV risks; in helping couples to learn their partners' HIV status before the initiation of sexual relations; and in addressing the three principal barriers to wider HIV-test acceptance: stigma, convenience, and privacy" (Walensky & Paltiel, 2006, p. 461). More recently, plans were announced to seek Food and Drug Administration approval for over-the-counter (OTC) sale of an oral fluid HIV test that would allow individuals to self-administer the test at home, obtain the results in about 20 min, and interpret such results following written instructions without the need of external help, phone calls, or clinic attendance (Richmond, 2005; Whellams, 2008; Wright & Katz, 2006).
As soon as the news of a possible OTC HIV test became known, speculation arose that single individuals who were dating or those with multiple partners might avail themselves of this new tool to screen sexual partners and decide, based on the test results, whether to engage in intercourse and whether to use condoms. At the same time, concerns grew that people might overlook the window period of an HIV-antibody test-the period in which the absence of antibodies make an HIV-infected individual appear to be uninfected (Harris, 2005). Although this concern merits attention, mathematical modeling has shown that even taking into account the increased risk posed by the window period, the use of HT can result in lower rates of transmission than inconsistent or no condom use in areas of high prevalence (Ventuneac et al., 2009; also see comments by Leu, Ventuneac, Levin, & Carballo-Dieguez, 2012).
Prior studies have shown that gay and bisexual men at high risk of HIV transmission (i.e., those who never or seldom use condoms) are nevertheless interested in avoiding HIV infection (Carballo-Dieguez & Bauermeister, 2004). This study was designed to investigate whether these men would be interested in testing themselves and their partners prior to sexual intercourse as a harm-reduction approach and the strategies that they would use.
We sought to investigate whether high-risk men who have sex with men (MSM; defined for this study as those with multiple partners, who never or rarely used condoms, and who engaged in RAI at least three times per month, on average) would be interested in using an OTC rapid home test, if it were available, to test themselves and their partners prior to intercourse. The results of our study show that most participants were enthusiastic about the possible availability of an OTC home test, and thought they could use such a test with their sexual partners. Participants expressed a variety of opinions concerning when to bring the issue up, where, and with what kind of partners. Furthermore, they creatively discussed possible strategies they could employ to approach the discussion. Although using the test before having sex could be seen as intrusive, it was also perceived as opening the gates to freedom and enjoyment.
Nevertheless, many participants also pointed out challenges that could be encountered trying to use home tests with a partner, such as testing killing the mood or being impractical in certain environments, with certain partners, and when individuals are under the influence of alcohol or drugs. Although participants anticipated that some prospective sexual partners might refuse to use a rapid home test, for the most part they did not think that they would face violent reactions or be unable to manage the situations that arose.
Although the possibility of an unanticipated positive result was seen as serious and problematic, participants expected both to react with empathy and to receive support from a casual partner in those circumstances. They felt that a positive result would be more complicated to handle in an ongoing partnership if it implied a breach of previously established rules.
Questions may be raised concerning the predictive validity that responses to our hypothetical scenario ("If the test were available, would you use it to screen sexual partners?") may have for actual use of the test. However, the large proportion of participants who chose to test themselves unassisted in front of the interviewer suggests at least that participants experienced no major barriers to testing themselves. This may increase their confidence to propose testing to a sexual partner.
Another concern has to do with the window period. If MSM chose to avail themselves of the rapid home test and used it to screen sexual partners, would that lead them to forget that an individual who tests negative might be infected or might even be in the highly contagious acute phase, thereby posing a higher risk of HIV transmission? This may be the case. Yet, our participants were already having high levels of unprotected intercourse with multiple partners in circumstances of high risk of HIV transmission. It is likely that potential partners who suspected or knew they were HIV infected but denied it might avoid situations in which they could be asked to take the test. Furthermore, as technologies advance, the window period could be significantly reduced (American Association for Clinical Chemistry, 2010; Branson, 2010; Pandori et al., 2009), thus decreasing this risk.
Other anticipated challenges to the use of HT as a partner-screening device are likely to come from the public health establishment. Often, a search for what may be optimum precludes us seeing what may be useful under certain circumstances. Aspiring to find a technology that confers 100% protection may lead us to overlook the potential of HT for high-risk populations like those we tested. Recent developments in biomedical approaches to prevention like vaginal microbicides (Abdool Karim et al., 2010) and pre-exposure prophylaxis (Grant et al., 2010) are only partially effective methods. Yet, they have been rightfully received as important advances in prevention and are being rolled out in demonstration projects ("300 Gay Men in SF," 2011) in community settings. HT to screen sexual partners will also be only partially effective. Nevertheless, it is a strategy that should not be discarded without further research on its acceptability and effectiveness.
Our study had several limitations. First, participants were a small number of self-selected volunteers who most likely were not representative of the MSM population at large. Second, participation in this research may have led the individuals to overestimate their likelihood of implementing HT with their partners. Specifically, having an extensive discussion with the interviewers on pros and cons of testing may have affected participants' reports of likelihood of future use. A second phase of this study is underway in which participants at high risk of contracting HIV are given free test kits to take home with the possibility of choosing to use them with prospective partners during a three-month period, at the end of which an evaluation takes place. Yet, within the aforementioned limitations, our study is the first to explore what issues may be raised by the OTC availability of this technology.
Technologies that do not interfere with sexual pleasure during intercourse are likely to be used when they become available. Studies are needed to evaluate the advantages and disadvantages of using OTC rapid HIV tests as a harm-reduction strategy.
Our study was conducted in New York City, following approval by the institutional review board of the New York State Psychiatric Institute. Recruitment advertisements indicated that researchers were studying possible uses of a rapid HIV home test. Recruitment took place at gay community organizations, testing sites, events such as Gay Pride, and online dating sites. Eligibility criteria included the following: male; 18 years of age or older; who engages in receptive anal intercourse (RAI) with other men at least three times per month, on average; HIV-negative by self-report; not involved in a monogamous relationship at the time of enrollment; who uses condoms on 20% or fewer of the RAI occasions; aware that unprotected RAI may lead to HIV transmission; and fluent in English or Spanish.
Volunteers were invited to come to our research offices. After signing a form consenting to participate in the study, they completed a baseline computer-assisted self-administered interview (CASI), were interviewed in depth by a researcher, were offered the possibility of testing themselves using a rapid HIV test, and, finally, completed a follow-up CASI. Those who elected to test themselves subsequently interpreted their results under the monitoring of the interviewer.
Measures and Tests
This assessment sought to characterize the sample. It included questions on sociodemographic characteristics, sexual practices, substance use, and sexually transmitted infection (STI) history. It also included a structured item requiring ranking of experienced priorities in a sexual encounter ("When I am about to have sex with a guy, the most important issues for me are ...", followed by eight possible answers presented in random order to different participants: "not getting HIV," "sexually satisfying my partner," "having a good time, enjoying sex, and getting sexually satisfied," "making sure we use condoms," "not getting a sexually transmitted disease (STD) or infection (by this we mean STDs other than HIV)," "that my partner will like me," "communicating our thoughts and feelings with each other," and "not passing a sexually transmitted disease (STD) or infection or HIV to my partner").
The purpose of the semi-structured interview was to understand if and how participants might use the OTC test to screen sexual partners. The interview followed a guide that covered the following topics: knowledge of rapid HIV tests; motivations to use it; advantages and disadvantages of rapid HT of sex partners; participants' perceived self-efficacy in utilizing such a test in a variety of scenarios; whether the participant would propose mutual testing to a partner; the effect of substance use on likelihood of using the home test; and their anticipated reactions to partner refusal, hostility, or eventual HIV-positive test results.
To verify whether individuals who expressed interest in testing themselves would actually do it, at the end of the in-depth interview, participants were offered the opportunity to test themselves using the OraQuick™ rapid HIV test (OraSure Technologies, Inc., Bethlehem, PA), which provides a result in less than 20 min. The interviewer observed silently as the participant followed written instructions, and only interrupted in case of error. To mimic the circumstance of OTC acquisition of the test, no training on its use or further explanations were offered.
After the participants had tested themselves for HIV (or declined to do it), we asked them, "When a rapid HIV home test becomes available over-the-counter, how likely is it that you will use it to test yourself at home?" Possible responses were, "There is no way I will use it," "It's unlikely," "It's likely," and "I will definitely use it." The same question was posed regarding testing sexual partners.
Quantitative CASI data were analyzed using Statistical Package for the Social Sciences software (SPSS Inc., Chicago, IL) to calculate frequencies and test for significant differences. Those who took the test in front of the interviewer were compared to those who did not on various demographic and sexual history variables. For continuous variables, t tests or Mann-Whitney tests (for variables with skewed distributions) were used. For categorical variables, chi-square tests were conducted.
To analyze the qualitative data, which constitutes the main data source for this study, audio recordings were transcribed, and transcriptions were checked against the former for accuracy. A first-level codebook was developed following the major topics covered in the interview. Using the software package NVivo (QSR International, Inc., Cambridge, MA), three independent coders reviewed transcripts, identifying data that fell under these codes. Intercoder comparisons were made on the first 10 transcripts until consensus was reached, and the codebook was amended and expanded for clarity. The remaining 47 transcripts were independently coded by two coders, and disagreements were resolved in consultation. Next, four investigators read the coded material and independently developed second-level codes based on the topics discussed by the participants. The independent codes were unified in a single codebook with definitions and examples. These second-level codes focused on aspects of initiation of the invitation to use home tests with a new partner, such as "where and when," "triggers," "verbal style," "challenges," and "partner hesitation or refusal." Finally, code reports for secondary codes were generated, and quotes from respondents were selected by the first author.
Four hundred and sixty-one men telephoned for screening over a nine-month period. The first 60 to meet eligibility criteria were enrolled. Three participants were eliminated, in two cases due to inconsistencies that cast doubt on the honesty of their reporting, and in the other case due to failure to complete study procedures. This resulted in a sample of 57 participants.
Table 1 presents the sociodemographic characteristics of the sample.
By eligibility criteria, all participants had been sexually active with more than one partner in the prior year. Table 2 presents the sexual risk behavior and substance use reported by the participants during the prior three months, as well as their lifetime history of STIs. Seventy-one percent of participants had been tested for HIV within the past two years (not shown in Table 2).
Table 3 presents the rankings that participants gave indicating the most important issue for them when they were about to have sex.
In summary, this was a sample of educated adult men of diverse ethnic backgrounds, who had multiple male sexual partners, frequently engaged in unprotected anal sex, consumed alcohol, and, to a lesser extent, used recreational drugs. The majority had at least one STI in the past. These men valued enjoyment of sex above avoidance of HIV and STIs.
At the onset of the interview, participants were asked if they would consider using a rapid home test to screen sexual partners. Initially, approximately one-half of the participants considered use of a home test to be most appropriate with new partners (i.e., online hookups and one-night stands), whereas the other half mostly considered it appropriate for partners with whom they had ongoing sexual relationships. However, about one-fifth of participants said at the beginning of the interview that they would not use the test with any partner.
Knowledge of rapid HIV tests
Many participants knew about the existence of rapid HIV tests, and some had even been tested for HIV with OraQuick in clinic settings. When informed by the staff that the manufacturer of the test was seeking licensing for OTC sale, most felt enthusiastic about the possibility of easy access to the test, although some expressed concerns about its possible cost:
I think having the option available is a no-brainer. I think, you know, whether or not people use it under different circumstances, that's ultimately going to be up to them anyway. But I think it would be important to have it available. (#018, Latino, age 23)
When, where, and how to discuss rapid home tests with a sexual partner
In response to the interviewer's question, participants discussed the possibility of using home tests to screen sexual partners, particularly in the context of mutual testing. Some participants speculated that it would be easier to do it with one-night stands than with steady partners, and pondered where and when to raise the issue. A few men felt that meeting someone online provided a perfect scenario to discuss rapid HT:
[There is] a wonderful application on iPhone[®] and BlackBerry[®], Grindr, where you have a location of gay people that are near you and their profile or whatever they want to send you. So in that instance, if I were doing that, and I was going specifically for a hookup, then it [the mention of HT] would be at the beginning. It would be, you know, "Are you clean?" "Are you STD free?" "What's going on?" ... Because some of those profiles will say "disease free" and stuff. (#063, White, age 28)
Others felt that a phone conversation or a face-to-face meeting at a public place would be more appropriate to discuss HT. For example, an HIV-counselor said:
I guess before we leave the bar, like, so, Are you a top? Are you a bottom? Oh, you're bottom, great, I'm a top. That's good. HIV negative?
Positive? ... Negative? Cool. You're not going to feel funny about me asking you to take the test, right? Because you know, I got-I went to [name of drugstore] last night and I bought a bunch of them so we've got to put the bitches to use. I test everybody. Like, one, it's my living. You know, I work in the field. And then on top of that, I got it here personally, so I've got to use them. (#017, Black, age 27)
Yet others felt that a public place would not provide sufficient privacy and that a home environment would be the most conducive to discuss HT. Some participants felt that forewarning was required before a face-to-face encounter if one were to ask a potential sexual partner to use the rapid home test.
Interestingly, a few participants thought that the rapid home test could be used after having sex:
So I don't know if it would be when the clothes were coming off. Maybe it would be after we had sex and then like maybe for the next time. (#023, White, age 46)
Different approaches were considered on how to present the idea of rapid HT. Some felt they could be very blunt:
I would just be very direct about saying, "Well, I'm interested in sexual health, well-being; would you mind taking this, you know, with me?" (#019, Latino, age 25)
Others would rather use persuasion:
[I would] say, "As far as I know, I'm negative, but I do have this kit, it's really unique, and it's great. And you know, before we do it, I'd like to get your OK. I'd like to show you my results, it only takes 20 minutes, you just put a Q-tip in your mouth, and you put it in a holder, and we can just talk. And this way, you'll know, and I'll know. And it's very important information." (#058, White, age 50)
I will slowly, slowly talk my way into it, or persuade the person to take an interest in it. I probably would do it first so that somebody could feel comfortable with it. (#024, Black, age 38)
Several participants said they would try to bring the topic up in a very casual way:
[I would] say oh, you know, I read a news article [laughter] or I saw on the Internet [laughter]. You know, that I probably, like, bring it up as casually as I possibly could. (#036, Black, age 33)
Special circumstances could be used to propose the use of rapid home tests:
If it was someone who was cheating on someone else, then you have another card to play in the sense that, you know, if you don't want to get caught and you don't want to get in trouble, then let's do that [use the rapid home test]. (#008, White, age 40)
I have had partners in the past who say, I don't have sex with a condom ... if that was a situation with a new partner ... and I wasn't in a trusting place, or I'm just smart about it and say well, listen, you know that's OK. But if that's the case, then-and you want to have anal sex, then this is what we're going to do. I could see that happening, absolutely. (#018, Latino, age 23)
Well there was one guy, he was like almost obsessively concerned with catching something. And you know, but he was dying to have sex ... I sort of had to stop myself from laughing because I would've said to hell with it. But he was just so-and this might've been something to really calm him down. (#005, White, age 62)
All these examples focused on new potential sex partners. However, participants also felt that a rapid home test could be used as relationships moved from casual to steady:
This kind of feels like we're kind of sexual buddies, so I mean, why not get tested together so we could both feel at ease and we don't have any limitations, we would feel, we'll feel OK? (#053, Latino, age 23)
Finally, some felt that if the rapid home test became a community norm, this would facilitate proposing its use to partners:
Maybe this becomes readily available, and we start doing this with everybody. ... The other is if a friend started to, suddenly started to regale me with his conquests, ... I would be more likely to request this of someone that I knew well. (#056, White, age 31)
The aforementioned examples come from interviews in which participants felt they could propose to use rapid home tests to screen some of their sexual partners. Yet some participants, at times even the same participants who had an optimistic outlook on HT, felt that there would be many challenges to using a rapid home test.
A common objection was that taking the test would kill the mood for sex or be incongruent with a sexual situation:
To wait 20 minutes to see what would happen would-I just couldn't see-that would put the brakes on whatever crescendo you're having with that sexual experience. It's, it's a buzz killer as they say, you know? (#008, White, age 40)
I'd probably freak out if somebody asked me to take a home sex-you know, a home kit. Like, what, who are you? Are you trained to do this? Like, who are you? Like, I'm just coming over to fuck you. (#017, Black, age 27)
The difficulty in using a rapid home test would be compounded by some of the environments in which sex may take place:
Anonymous sex is anonymous sex, and who the hell is going to be walking around with one of those kits on them? If you're at a damn peepshow booth or whatever, you just want to get off and go about [your] business, you know? ... "Oh, what? You know what, let me check this guy out over here. I don't need this shit." (#022, Black, age 52)
In the crack house after someone desperately wants a hit, that you know, they'll clear the room so that these two people can be together so that you can give drugs for sex. And at that point, somebody will let you fuck them, somebody will let you suck them, but you know, whatever. And there's no discussion of a condom, there's no discussion of HIV. In fact, it's the raw degradation of the person that becomes what's valued. It's a very sick, sick thing. Depraved ... . (#002, Black, age 57)
Being under the influence of alcohol or drugs may affect the likelihood of using rapid home tests, the efficiency with which it is used, or the possibility of waiting 20 min to read the results. Pros and cons were expressed by different participants and summarily presented by one:
Man, if I could meet someone who would smoke a joint with me while getting our test results, that's a dream boat [laughter]. But I feel like it could possibly impact, I mean, it could affect whether or not you're doing the test result properly, or it might be even easier to bring up a topic that for some people is hard to talk about if they've had a drink in them and they're a little loosened up and a little more open and understanding. ... Though, on end, getting a positive result while you're not sober, that could be bad. (#009, Latino, age 20)
Most participants who had experience with alcohol or drugs felt that they would be unlikely to use the test if they were high or inebriated:
When I'm high, I don't care about anything, so I don't think I would stop to do it, you know. (#040, Latino, age 36)
I don't think when you're smoking, or rather drinking alcohol, you're, you're going to do it because you're just-there's no time when I've drank where I've asked someone if they're HIV positive or negative. Or if I have, it didn't really faze me. It just sort of, you're in a, you know, in a tipsy trance. (#045, race unknown, age 36)
The type of relationship between the sexual partners may also affect the likelihood of the test being used:
I'm a sex worker, so it's just, they come and go. My customers wouldn't want to hear that. (#040, Latino, age 36)
One participant feared that the invitation to take the rapid home test could be interpreted as racially motivated:
You don't want to be offending anyone ... just because you're African American or you're Hispanic, like myself, doesn't mean you have to get tested. "You want [me] to get tested 'cause I'm black?" (#021, Latino, age 18)
Practical matters were also brought up:
Who pays for it? Do we split the 10/10? Do I pay the 20? You know, you're topping me so you pay for it or I'm topping you so I pay for it? (#021, Latino, age 18)
Partner refusal was seen as another possible challenge, although participants tended to assume refusal would be a warning about the potential partner's positive HIV status or previous sexual risk behavior. This would lead to either not having sex or using condoms:
I would also say that "You know, this is no guarantee because there is that window period, but wouldn't you feel comfortable knowing for sure?" That's how I would phrase it. And if the person said, "No, let's just do it [have sex]," I think that would be like a good break for me to just pull out of the situation. I think this would help me to-because there is that little gray area where sometimes I do take a risk, and I think if the person was really willing and adamant not to do this [use a home test], I think that would scare me. (#058, White, age 50)
Beyond refusal to take the home test, most participants did not anticipate that the invitation to use a rapid home test would generate any violent reactions. Referring to casual partners, many participants stated that they trusted their skills to judge a situation and would not bring up the idea of using home tests if there were a potential for violence. Most participants felt they could handle aggression or violence in the rare event it might occur:
I know this sounds cavalier, but I'm not afraid for my physical-I mean, I feel like I could defend myself and get out of a situation, even if I'm in somebody's apartment. (#058, White, age 50)
What if the test were positive?
When we asked participants what would happen "if a test came up positive," many made distinctions based on who was getting the positive test result and how long they had known each other. In the case of finding out that a prospective sexual partner was unknowingly infected, participants frequently anticipated showing empathy and trying to help the man get connected with the appropriate health services:
I'd probably put my arm around them and say, you know, what can I do to help you? Is this a shock? First I'd ask them. If he said yeah, I'd say, Well, let's see if we can do something. Because I'm sure that's got to be a terrible thing to hit you, to find out about. (#008, White, age 40)
Well, there's a hundred ways a person can react. If they are devastated, I would try to do all I could to help them, comfort them, talk to them and tell them, Look, your life's not over yet. They're doing a lot of great things nowadays. Don't think that I'm going to jump ship just because you turned out positive. (#028, White, age 54)
In very few cases, participants said they would disengage immediately from the situation (I = interviewer, R = respondent):
I: So let's say you propose this test to somebody and they say yes, and they do it, and they get a positive result.
R: Man, got to go. [laughter]
I: Yeah, that's it?
R: That would be it. I mean, people say you can do like condoms and stuff, but I don't really like the feel of them.
I: So that would be no sex. And what if they were distressed?
R: [laughter] What would that have to do with me? Clearly you need to go check into your past. [laughter] (#059, Black, age 21)
Most participants felt that a positive result would kill the mood for sex. Yet, others thought they would still have sex but use protection:
I guess that's when it comes down to the looks or the perfect man versus the average Joe. If it's the perfect man, I believe I would still go forward with having sex. I guess I would definitely be more cautious on what I do, how I do it, and just-it would take away from the enjoyment, but at least now I would know exactly like what I'm getting myself into. If it's just the average Joe ... if I'm not that attracted to the person, I guess I would just be like well, mine says negative, yours says positive, we can't really-opposites don't attract. (#012, Latino, age 25)
Interestingly, participants felt that the most complicated situations would arise not in casual relationships, but in ongoing partnerships. In the latter case, a positive test result could signify a breach of agreement either on exclusivity or on condom use with partners outside the relationship. This, in turn, could lead participants to a variety of reactions ranging from support to aggression and violence. Also, if prior to testing the men had had unprotected sex, participants said that they obviously would worry about their own status:
If it was somebody I've had a fling with, then I would immediately think did I-was he wearing a condom when I went down on him, or was he wearing a condom when he-you know. I would just try to backtrack and try to figure out if there's a possibility that I would be infected. If it was somebody I was close with, then I just, I would ask, "Are you sure?" I guess. But I would worry about my own safety. (#035, Asian, age 35)
If the positive results corresponded to the participant himself, most said they anticipated they would be very distressed and would not proceed with sex:
I would have the devastated look on my face because I wouldn't be expecting that. And I'd be apologizing profusely. ... I wouldn't have sex with someone, that's for sure. That would be a limit that I would, if I was in someone else's place, I'd be putting my clothes on and getting out the door. If they were at my place, I would be encouraging them to do the same thing because I would be in no mood for having sex anymore. (008, White, age 40)
Some were concerned about confidentiality, whereas others felt that they would have other priorities:
I: And how would it be like for you to have this other person know your status?
R: Kind of scary, like I think I would feel kind of violated in a way, too? Like, you know, like, this person has too much information about me. That just met me. 'Cause now they know. (015, Black, age 39)
I: And how concerned would you be about this person now knowing your HIV status?
R: (pause) I guess you would ideally want to tell [the] people that you want to know, that you have HIV; but news spreads fast, you know, in communities or whatever. I mean, I guess I would have less interest in my reputation than my health. (#019, Latino, age 25)
Finally, several participants said that their next step after testing would be to seek confirmatory testing followed by treatment.
Forty-two participants (74%) chose to test themselves in front of the interviewer. Those who decided not to test themselves stated a variety of reasons, such as already having an appointment to do it at a clinic or wanting to do it together with a partner. Most participants who chose to test themselves did so without mistake, although many paid little attention to the written instructions and focused instead on a visual card. The most common mistake observed was the participant touching the pad of the testing wand with their fingers. Other mistakes included swabbing the gums multiple times and eating or drinking just before taking the test. One participant, who appeared very anxious about taking the test, immediately after opening the test vial was bringing the vial to his lips to drink the solution it contained, and was promptly stopped by the interviewer before doing so.
Men who took the test in front of the interviewer (n = 42) were compared to those who did not (n = 15) on all of the demographic and sexual history variables reported in the previous Baseline CASI results section. A few differences were significant at the .05 level. Those who took the test had lower incomes (Mdn = 23,091 vs. 40,000; U = 83.00; p = .037), reported more unprotected insertive anal sex (Mdn = 3 vs. 1; U = 207.00; p = .048), were less likely to have had syphilis (12% vs. 40%; χ2 = 5.60, p = .027), and were less likely to have had gonorrhea (7% vs. 33%; χ2 = 6.28, p = .024).
Of the 57 men in the study, 87% state d that they would be likely to test themselves if the test became available OTC, and 80% said they would be likely to use the kit to test sexual partners at home. Most preferred an oral fluid test over a blood (finger prick) test. Participants reported their likelihood of using each product on a scale from 1 to 10. The mean rating for the oral fluid test was 9.22 compared to 4.55 for a blood test.
Strategy in Action: HIV Testing Innovations Contribute to NHAS Goal
February 1, 2012
By Ronald Valdiserri, M.D., M.P.H., Deputy Assistant Secretary for Health, Infectious Diseases, and Director, Office of HIV/AIDS Policy, U.S. Department of Health and Human Services
With an estimated 20 percent of people living with HIV in the United States unaware of their status, strengthening our HIV testing efforts will be key to achieving the goals of the National HIV/AIDS Strategy (NHAS). Fortunately, many innovative HIV testing efforts are underway in communities across the country.
HIV testing is integral to HIV prevention, treatment, and care. Knowledge of one's HIV status is important for preventing the spread of disease. Studies show that individuals who learn they are infected with HIV take active steps to reduce the likelihood of transmitting the virus to their partners. Early diagnosis of HIV helps to ensure that people living with the virus are linked into care and receive life-saving treatment. And recently we've learned that antiretroviral treatment can also help to prevent the further spread of HIV. Therefore, the NHAS aims to increase, by 2015, from 79 percent to 90 percent the percentage of people living with HIV who know their serostatus (from 948,000 to 1,080,000 people).
From Maine to California, health departments, community-based organizations, substance abuse and mental health programs, health care providers, hospitals, and others are implementing novel and effective approaches to HIV testing to help contribute to this important outcome. Examples we've heard about recently include:
· HIV Screening Offered at the Department of Motor Vehicles - An innovative example of the Strategy's call for greater collaboration among government service providers is underway in Washington, DC, where HIV testing has been offered at the Department of Motor Vehicles for the past year. While waiting to get a driver's license, temporary tags or other services, motorists visiting the Department of Motor Vehicles service center in the nation's capital can get a free HIV test. This innovative collaboration between the DMV and the DC Department of Health (DOH) has tested more than 5,000 people since the program started in a single location in October 2010. According to Family and Medical Counseling Service Inc., the non-profit group that runs the program under a grant from DOH, between 25 and 35 people get tested every day, and anyone who is tested gets $7 off his or her DMV services. If someone tests positive, the nonprofit offers a ride to its office where staff can set up counseling and a doctor's appointment. Building on the success of the DMV effort, officials expanded the program in late 2011 to offer testing at an office where Washington residents register for food stamps, Medicaid, and other government assistance. The same nonprofit will run the program there, offering as an incentive a $5 gift card to a local grocery store.
· Testing at Community Activities - In Pine Ridge, South Dakota, the Oglala Sioux tribe partnered with its local Indian Health Service facility to increase the availability of HIV screening in nonclinical, community-based settings. An experienced and well-regarded public health nurse has taken HIV testing to events and venues where there may not normally be a health-related activity. Over the past year, this locally initiated program has offered confidential HIV testing at community potlucks, rodeos, basketball games and Pow Wows. Bringing HIV testing to nonclinical settings has allowed them to reach community members who may not be in regular health care, including young people, and provide them with HIV education and the opportunity for confidential HIV testing.
· Promoting the HIV-STD Link and Encouraging Screening - Responding to a recent special surveillance report indicating a 23% increase in the number of primary and secondary syphilis cases in Chicago and a documented high rate of HIV-syphilis co-infection especially among MSM, the Chicago Department of Public Health recently launched the "Get Tested Chicago " campaign to encourage individuals to get tested for HIV and other Sexually Transmitted Infections (STI), including syphilis and, if diagnosed, to get into care. The public awareness campaign includes targeted billboards, radio public service announcements (PSAs), and bus advertisements aimed at early detection, testing and awareness. The campaign makes the link between syphilis, as well as other sexually transmitted infections, and HIV. It notes that studies have repeatedly demonstrated that people are more likely to become infected with HIV when other STDs are present. Moreover, it informs Chicagoans that if a person is HIV-positive, or if the immune system is weakened for any reason, syphilis (and other STIs) may progress faster and do more damage to the body.
· "Would you or wouldn't you take an HIV test?" - In San Diego, the "Lead the Way " campaign reflects the Strategy's call to intensify HIV prevention efforts in communities where HIV is most heavily concentrated. The campaign aims to have all adults in the city's 92103 and 92104 ZIP codes answer the question, "Would you or wouldn't you take an HIV test?" Researchers at the University of California, San Diego (UCSD), designed and are implementing "Lead the Way," with support from the National Institutes of Health. "UCSD researchers want to show that we can reduce the spread of HIV now, even without a vaccine. HIV testing is easy, confidential and is the simplest way to help our local community fight the spread of HIV/AIDS," observed Susan Little, MD, professor of medicine in UCSD's Division of Infectious Diseases and lead researcher of "Lead the Way." The campaign operates a drop-in testing center and sets up mobile testing sites at a variety of community events and venues. In addition, trained HIV testers from UCSD's Antiviral Research Center are visiting residential locations in randomly selected areas throughout the two ZIP codes to offer free rapid HIV tests that will provide results in minutes. Those that do not wish to participate in the finger-prick test will have the option of completing a brief survey.
"Volunteering to take the quick finger-prick test or filling out the survey will help us understand why people will or will not take an HIV test. If we can understand the psychology, we can create more effective campaigns to promote testing. The ultimate goal is that everyone gets tested and those who need treatment receive it, so we can significantly curb the spread of HIV," Dr. Little said.
These are just some of the many significant steps taken over past year to help the nation reach the Strategy's goals. What innovative approaches to HIV testing are underway in your community? Share your examples to inspire others in the Comments section below.
For more information, visit CDC's HIV Testing page or read the Kaiser Family Foundation's 2011 fact sheet "HIV Testing in the United States".