Results of AIDSVAX trials, while disappointing, mark the successful completion of the first large-scale efficacy trials of an HIV vaccine; with 28 trials of 24 different vaccines under way and a new phase 3 trial scheduled for late 2003, the first HIV vaccine may be approved within the next decade.1,2 The advent of a safe and efficacious HIV vaccine, however, does not guarantee adoption. HIV vaccine availability may engender a host of new challenges.
Low adoption rates of existing vaccines, additional obstacles posed by HIV/AIDS stigma and mistrust, and marked ethnic/racial health disparities suggest it is vital to investigate consumer adoption intentions before a U.S. Food and Drug Administration (FDA)–approved vaccine is available for dissemination. The purpose of this study was to assess concerns, motivators, and intentions regarding uptake of hypothetical U.S. FDA–approved HIV vaccines among diverse consumers at elevated risk for HIV.
Without consumer uptake, even the most efficacious HIV vaccines will have little success in controlling the AIDS pandemic. Yet, ∼50,000 U.S. adults die annually of diseases for which safe and efficacious vaccines exist.3,4 Suboptimal vaccine adoption is reflected in immunization rates below Centers for Disease Control and Prevention targets for various at-risk populations: influenza (13%) and pneumococcal (13%) vaccination rates among noninstitutionalized high-risk adults,4 for example, are well below objectives of 60% coverage.5 Among men who have sex with men, hepatitis B vaccine coverage is 9% in contrast to the Centers for Disease Control and Prevention’s goal of 50% coverage.6 Overall immunization rates are up to 50% lower among African Americans and Latinos,3,7,8 populations at disproportionately high risk for HIV.
In contrast to existing vaccines, the dissemination of U.S. FDA–approved HIV vaccines will likely face further formidable obstacles because of the stigma,9,10 fear, and mistrust11–13 associated with HIV. Ethnic/racial and socioeconomic disparities in receiving and adhering to highly active antiretroviral therapy,14,15 including the dissemination of azidothymidine earlier in the epidemic,16 and marked underrepresentation of ethnic minorities in clinical trials of agents against HIV17 also suggest potent obstacles to the dissemination of approved HIV vaccines among communities at highest risk for HIV.
Extensive research has focused on willingness to participate18–29 in HIV vaccine trials. Vaccine preparedness research is vital to planning and launching phase 3 clinical trials.3 Key distinctions warrant caution, however, in extrapolating from vaccine trials and trial preparedness to adoption and dissemination of U.S. FDA–approved vaccines. First, altruism and wanting to contribute to AIDS research, the most frequently cited motivators for HIV vaccine trial participation,22,24,26,27 are unlikely to serve as principal motivators for uptake of a U.S. FDA–approved HIV vaccine. Second, the motivation to be protected against HIV infection is likely to play a much more dominant role in the adoption of a posttrial vaccine with known efficacy, as compared with participation in a double-blinded, placebo-controlled trial with a vaccine of unknown efficacy. Third, individuals who volunteer and are then selected to participate in clinical trials may not be representative of the larger at-risk population indicated for HIV vaccination, raising concerns about the external validity of behavioral studies based on vaccine trials. Behavioral research specific to posttrial HIV vaccine adoption is warranted.
In the nascent field of research on hypothetical U.S. FDA–approved HIV vaccines, factors associated with adoption intentions include cost, vaccine efficacy, and health beliefs.30–36 Among 541 Midwestern college students, HIV vaccine cost above $100 was perceived as a potential barrier to adoption.33 Adolescents from community health clinics indicated that vaccine efficacy was important in their acceptance of a hypothetical HIV vaccine.34,36 Health beliefs such as perceived susceptibility to HIV infection and perceived barriers were also associated with intention to adopt an HIV vaccine among Midwestern adolescents.32,33,37 In 1 study that addressed potential risk behavior change, 77% of adolescents (n = 142) indicated that people would increase HIV risk behaviors after immunization with a 90% efficacious vaccine.36
Although these investigations suggest potential concerns and motivators for uptake of approved HIV vaccines, as well as the possibility of risk behavior increases, findings based on responses of Midwestern adolescents and college students may not be generalizable to populations at high risk for HIV infection. In addition, both HIV vaccine trial and posttrial behavioral investigations largely overlook Latinos, a population with an increasing proportion of overall AIDS diagnoses and a smaller decline in AIDS deaths compared with non-Hispanic whites.38 The present investigation explored concerns, motivators, and intentions regarding adoption of hypothetical post–efficacy trial preventive HIV vaccines among diverse populations at risk for HIV infection in Los Angeles, the second largest AIDS epicenter in the United States.
MATERIALS AND METHODS
Participants were recruited from 7 diverse settings in Los Angeles using purposive venue-based sampling.39–41 Venues were selected based on 3 criteria: 1) having a high proportion of individuals at elevated risk for HIV/AIDS; 2) inclusion of ethnically and sexually diverse communities across Los Angeles; and 3) representing likely settings for future dissemination of HIV vaccines. Participants included the following: 1) men attending a sexually transmitted disease clinic housed in a gay and lesbian services organization; 2) male and female injection drug users at 2 needle exchange programs; 3) Spanish-speaking Latinos (men who have sex with men, women, and heterosexual men) at 2 community-based health care clinics; 4) women at a community health clinic serving predominantly African Americans; and 5) young men and women (aged 18–24 years) attending a social service agency for gay street youth.
All participants were 18 years of age or older at the time of recruitment and provided informed consent. The UCLA Human Subjects Protection Committee and the Institutional Review Board at the University of Toronto reviewed and approved the study protocol. Participants were reimbursed $30 for engaging in the focus group.
Nine focus groups were conducted with 8 to 13 participants per group (n = 99). The median age of focus group participants was 33 years (range, 18–56 years). Just over one half (52%) of participants were male. Most participants (44%) were Latino/a; 28% were white; 22%, African American; and 6%, other race/ethnicity. Of the participants, 43% were heterosexual; 27%, gay; 20%, bisexual; and 3%, lesbian. Over two-thirds (69%) of participants were single. Overall, about one half of participants were unemployed (51%), had no health insurance (51%), and reported income of less than $10,000 (48%), and one third were homeless. Sociodemographic characteristics of participants by focus group are presented in Table 1.
Data were collected using a semistructured open-ended focus group interview guide.42 The interview guide was translated into Spanish, back-translated into English, and then revised in Spanish to create the Spanish-language version. The interview guide elicited participants’ concerns, motivations, and intentions regarding adoption of hypothetical posttrial preventive HIV vaccines. Focus group participants were asked to give their own opinions as well as their perceptions of the opinions and responses of their peers. At the end of each 75- to 90-minute focus group, participants were asked to complete a brief anonymous sociodemographic questionnaire.
The focus group protocol consisted of 7 questions. The first 3 questions addressed general and HIV-specific vaccine knowledge and beliefs, with scripted probes that invoked polio, influenza, and tuberculosis vaccines as examples if they were not first mentioned by participants. The final 4 questions elicited concerns, motivations, and intentions regarding uptake of hypothetical U.S. FDA–approved HIV vaccines and were the focus of the present investigation. The facilitator prefaced the latter 4 questions with the following explanation:
Just to make sure we are all discussing the same thing, the goal of a vaccine is to protect you from a particular disease, to make you immune to the disease. Immunity means that you cannot get the disease even if you are exposed to it. The goal of an ideal HIV/AIDS vaccine would be to protect you against infection with HIV, the virus that causes AIDS. Remember, again, we are talking about an as-if situation; so there are no right or wrong answers to the following questions about possible HIV/AIDS vaccines in the future. Now, we would like to ask a few questions assuming an HIV/AIDS vaccine were available tomorrow and were approved by the U.S. government (ie, the FDA) for use. We ask you to speculate or think about how you and your friends might respond.
The facilitator did not offer set definitions of vaccine efficacy, the composition of the hypothetical vaccine, or prescribed values of other vaccine characteristics, because our goal was to elicit participants’ understanding and beliefs. Facilitators used scripted probes to explore efficacy (50% vs. 95%; we also used the word “effective” or “how well the vaccine works”), duration of protection (10 years vs. a lifetime; “how long the vaccine would work”), and vaccine-induced infection (no risk vs. small risk; “what if the vaccine could not infect you?”) after participants raised these issues. As participants did not raise concerns about vaccine-induced HIV seropositivity, the facilitator used a scripted probe to elicit responses: “What if the vaccine made you test HIV-positive as a normal immune response to the vaccine?” In a follow-up probe, the facilitator asked, “What if there were a special test that could tell if you were HIV-positive due to an immune response to the vaccine or because of actual HIV infection?”
Focus groups were audiotaped and transcribed verbatim. Spanish-language focus groups were transcribed in Spanish and translated into English for data analysis. Transcripts were loaded into Ethnograph (Qualis Research Associates, Denver, CO), a software program for computer-based text search and retrieval. Multiple readings of the transcripts were performed by independent investigators using narrative thematic analysis to identify major themes.43 Next, a line-by-line review of the transcripts was performed, and first-level codes (descriptors of important components of the interviews) were noted in the margins. All codes were entered into Ethnograph tagged to the associated segments of text. Text corresponding to each of the first-level codes was printed and reviewed by at least 2 independent investigators; using a method of constant comparison,43,44 subcodes were established to divide the first-level codes into finer categories. The results correspond to the emergent categories, and all quotations are drawn from the focus groups.
Respondents’ concerns regarding HIV vaccine uptake included the following: 1) vaccine necessity, 2) vaccine efficacy, 3) vaccine-induced HIV infection, 4) vaccine-induced HIV seropositivity, 5) vaccine side effects, 6) duration of protection, 7) cross-clade protection, 8) cost and access, 9) trustworthiness of vaccine manufacturers, scientists, and government, and 10) relationship concerns.
One concern was whether participants needed to be vaccinated against HIV at all: “If you’re going to practice everything safe and not worry about getting AIDS, who cares about the vaccine?” Some respondents who perceived no or minimal risk for HIV infection indicated they would forego vaccination: “A lot of my friends are IV drug users and they don’t share needles and they do things not to get AIDS ... The way I’ve been doing things ... I’m not going to get AIDS so it doesn’t really affect me too much.” Another respondent stated, “I don’t need the vaccine.”
A related line of reasoning was that since one had endured the AIDS epidemic for over a decade without contracting HIV infection, there was no need to adopt a vaccine. One respondent said, “I’ve gone this long not catching it. I’m not really in that big of a hurry to get vaccinated.”
Respondents raised concerns about vaccine efficacy. As 1 respondent stated, “I have to find out if it worked or not.” In general, respondents expected near 100% efficacy. “I would get vaccinated only if they tell me that it is 100% effective,” is a statement characteristic of many respondents. Some respondents indicated willingness to adopt a <100% efficacious vaccine; however, respondents expressed that the lower the efficacy of an HIV vaccine, the less likely they were to get vaccinated.
Participants also expressed divergent understandings about the concept of efficacy. One point of view in response to “70% vaccine efficacy” was, “70% of the people who get this vaccine will then be [100%] immune to the HIV virus.” Another view was, “There’s a 70% chance you won’t get it if you take this.”
Vaccine-Induced HIV Infection
Participants expressed fears that the vaccine might cause HIV infection, AIDS, or death. As 1 respondent noted, “I remember reading pamphlets for diseases much less severe than AIDS. I mean, extreme risk could be fatal from the vaccine.” For some, fear of iatrogenic infection led to strong doubts about adoption: “The possibility of getting the virus through the vaccine ... this makes me doubt if I would do it.”
Related to the fear of vaccine-induced infection, respondents expressed concern that an HIV vaccine would incorporate a small yet potentially infectious dose of live virus. “The bad thing,” as 1 respondent noted, “is that they are injecting some sort of the virus into you.” Alluding to the belief that one might contract a disease from a vaccine, another respondent said, “I don’t know; it would scare me. Like, I got the flu shot once and ended up getting the flu!”
Vaccine-Induced HIV Seropositivity
Participants did not seem cognizant of the fact that testing HIV positive might be an aspect of HIV immunization until the facilitator, as part of a scripted probe, explained vaccine-induced HIV seropositivity. Participants seemed shocked to learn that an HIV vaccine might lead to an HIV-positive test result. As 1 respondent indicated, “I don’t think I would take that chance.” Respondents expressed concern about the ability to discern a vaccine-induced immune response from actual HIV infection: “How could they ever differentiate between a marker and really having HIV in your system?” The perceived ambiguity “would cause a lot of stress to people,” as 1 respondent noted. Another respondent summed it up: “Then I’m living in a constant state of fear.” Another participant expressed concern about infecting others if he were HIV positive in response to immunization: “So, as a technicality, you are HIV-positive? ... And you can give it to somebody?”
Although some respondents tentatively accepted the idea that a “special” test could distinguish between HIV infection and a vaccine-induced immune response, respondents were skeptical about such a test or simply perplexed. As 1 participant stated, “Which test do you trust? They’re telling you two completely different answers at different times. How can you really be sure?” Another respondent stated, “I would be confused.”
Related to concerns about testing HIV positive were the social side effects of an HIV-positive result, including stigma and discrimination. “There are repercussions,” said 1 participant, “in the long-term that would be used against you to be HIV-positive.” Another respondent stated, “And what about the stigma that it creates; I am going to say, ”the result of my HIV tests are positive, but I don’t have HIV?”’
Participants raised concerns about the effects of testing HIV positive on insurance, immigration, and employment. One respondent noted, “Even insurance-wise, if you got tested with your doctor and you didn’t ask for a test, that told the insurance company that you were already too risky.” “I would not be able to apply for legal residency in the U.S.,” reported another respondent, “because my HIV test would test positive if I’m vaccinated. There are also problems with discrimination at work.”
Respondents raised concerns about potential short- and long-term side effects of an HIV vaccine, including minor (pain at the injection site) as well as more serious (“permanent disability”) side effects. Respondents also expressed divergent ideas about what would be considered a minor side effect. As 1 respondent said, “If the side effects were just pain and a scar, that isn’t anything, but if it was the flu ... I don’t like the flu.” Long-term side effects were most worrisome to respondents. As 1 participant said, “If there were long-term side effects like lymph nodes or something ... What if it messes up your insides?” Female participants expressed concern about the long-term effects of the vaccine on fertility. As 1 woman asked, “Would it damage your reproductive system?” Women, in particular, also raised concerns about possible teratogenic effects of the vaccine and, further, about whether they might pass on HIV infection to their unborn children. One woman explained, “As far as ... a vaccine for the disease, as long as your body doesn’t pass the genes to your children.” Finally, unforeseen vaccine side effects or adverse reactions also evoked concerns about culpability and follow-up care. As 1 participant noted, “Are they going to take care of those people that got it [the vaccine]? Is the government going to take care of those people for the rest of their lives? They screwed them up.”
Duration of Protection
Participants expressed concerns regarding the duration of protection an HIV vaccine would confer. As 1 respondent noted, “I think ... that you would need to get another shot every five years.” Respondents suggested that the more that would be required of people to keep their immunization current (eg, booster injections), the less compliance there would be: “I would say that people get tired. Maybe they would get it the first year, but who knows if they would do it in the second year. For example, if we were to get the same vaccines that we got in our childhood every five years, I think we would not do it.” Respondents also expressed concern that the vaccine might “wear off” without their knowing it: “Like the vaccine keeps you inoculated for a year and then they think it’s going to be forever and ... after a year ... it quits working.” Respondents worried that people might increase risk behaviors in response to immunization, thinking that they were protected forever (again, presuming 100% efficacy) and then contract HIV when the vaccine efficacy wanes.
Respondents expressed concerns about the ability of an HIV vaccine to protect against >1 subtype of the virus. As 1 respondent noted, “The virus from the United States is different than the virus from other countries. The virus 1 and the virus 2; here we have more of virus 1. So if people come from other countries, they will infect others with virus 2.”
Respondents also related cross-clade protection to vulnerability due to increased risk behaviors: “One concern that I just thought of is since [there are] different strains in mutation, if people were to get vaccinated would they then assume that they were completely safe when they might actually be able to be exposed to a different strain?”
Cost and Access
Vaccine cost and accessibility was another area of concern. Some participants presumed that if an HIV vaccine existed, the U.S. government along with health insurance companies would cover the cost; thus, they were not concerned about cost. Others worried about ability to pay for vaccines among those at elevated risk for HIV. Concerns ranged from uncertainty—”Is it going to be like you can get it free no matter what?”—to fear of exclusion: “It’s going to cost money ... that’s what I think. If you don’t have money, you are out.” “What is the point of having 10 injections,” another respondent noted, “if people don’t have the money for it?” Willingness to pay for a vaccine was associated with efficacy: “I would spend a lot of money if I was sure that this was a real effective drug,” noted 1 respondent. Willingness to pay was also related to perception of HIV risk: “You have to weigh in the factor of how high at risk are you,” noted another respondent. Paradoxically, a few respondents indicated concern about a free vaccine: “I wouldn’t get it even if I thought they had one especially if they are giving it away free. I wouldn’t put myself at risk.” For some, a free vaccine was associated with greater risk and uncertainties about safety and efficacy.
In addition to cost, participants raised concerns about the accessibility of an HIV vaccine. As 1 respondent asked, “Who will get the vaccine? Is everybody getting it? The health departments? Would doctors or family practitioners get it?” Respondents specifically articulated concerns about vaccine access for individuals of low socioeconomic status and ethnic minorities: “Is it going to be available to people ... even in low income neighborhoods, and the people that are minorities, are they going to be able to get access to it?”
Respondents also raised concerns about how HIV vaccines would be disseminated and the stigma associated with attending an HIV vaccine clinic or distribution site. “Who are giving the vaccines? What clinics? They are going to point and say, ‘Oh, that one, who knows, what she is doing because look she’s going into the AIDS clinic.”’
Trust in vaccine manufacturers, scientists, government, and the U.S. FDA, in particular, emerged as another area of concern. Issues regarding trust fell into 2 domains: concerns about competence (ie, unintentional medical errors) and concerns about conspiracy. Participants suggested that strong concerns about the government or drug manufacturers’ trustworthiness in either domain might result in lower levels of HIV vaccine adoption.
In regard to concerns about competence, a respondent noted, “I don’t trust the government. I’d see what happened, if they would recall it and come out with something else and see how many times they mess up before I tried anything.” Some respondents wanted to know who would do the research to determine if the vaccine were safe and efficacious. One participant noted, “How many years were they in the study? Who did the study?” Another respondent stated, “I want to see their PhD; I want to see their license ... everything!” Other participants stated, “I wouldn’t take the government’s word for it,” and “I wouldn’t believe the statistics I got from the government,” suggesting concerns about the competence and integrity of government-sponsored research.
Concerns about conspiracy were multifaceted. Some respondents had specific conspiratorial fears that the government might be secretly trying to harm certain groups of people by distributing an alleged HIV vaccine (eg, “I don’t trust the government because of the fact that they are not thrilled about gay people in the world”). Alternately, some respondents believed that an HIV vaccine was already available, or could be available, but was being suppressed. Along these lines, respondents expressed suspicions that the U.S. Government wanted the AIDS epidemic to continue as it eliminated “undesirable” people: “junkies, whores and faggots.” “I wonder what they are going to say about the gays,” noted 1 respondent; “they won’t get it.” Respondents also suggested that a vaccine would cut into the profits that pharmaceutical companies reap on AIDS drugs; therefore, these companies were not interested in developing or deploying HIV vaccines.
Overall, respondents did not differentiate between scientists, drug manufacturers, and the government in regard to who would develop and test a vaccine. If they distrusted the government, they were likely to distrust vaccine scientists, manufacturers, and public health officials as well and to reject an HIV vaccine.
Female participants, in particular, expressed concerns about the potential reactions of their family and spouse to their being vaccinated against HIV. As 1 female respondent explained, “Like for example, if there’s a couple that has been together for 15 years, and let’s say we give them the shot, but then why are you getting the vaccine if I have only been with you?” Another female respondent noted, “Many people are already married and will say, ‘Ah, let’s not get the injection because we are meant for each other.”‘ Adopting an HIV vaccine was seen as a signifier of mistrust in a relationship. Female participants also expressed concerns that married women do not perceive themselves to be at risk for HIV: “The men come home and tell the women they love them, desire them, and she doesn’t know, so she is not going to get the vaccine.” In addition, female participants articulated doubts about men’s perception of risk and willingness to adopt an HIV vaccine: “There will be couples that won’t [get the vaccine], the man is macho,” also invoking the power dynamics in heterosexual relationships, which they expressed as a potential barrier to women’s adopting an HIV vaccine.
Respondents indicated several motivators for adopting a U.S. FDA–approved preventive HIV vaccine, including the following: 1) protection against HIV infection, 2) ability to engage in unprotected sex without the risk of HIV, 3) endorsement of the vaccine by trusted authorities, and 4) improving overall health.
Protection Against HIV
Protection against HIV infection was expressed as a motivation for HIV vaccine uptake. As 1 respondent noted, “I would get vaccinated so that I don’t get HIV.” A corollary to this motivation was that perceived risk for HIV was tied to adoption intention. One type of risk, as 1 participant indicated, was “your partner might be positive.” Another respondent suggested that people at high risk of becoming infected with HIV would be more likely to accept vaccination: “Health care workers that are exposed to blood products every day of their lives ... [or] a prostitute.” Respondents also mentioned that teenagers who are sexually active might want to be vaccinated, as would injection drug users. Likewise, participants indicated that the more efficacious an HIV vaccine was, the more motivated respondents would be to be vaccinated. As 1 respondent stated, “If it’s going to do it for the rest of your life and not get it then it would be worth it if it was completely proven.”
The ability to engage in unprotected sex without risk of HIV transmission was raised as another motivation for HIV vaccine adoption: “I’d rather not be safe and not have the risk.” Another respondent stated that she would get vaccinated “to practice sex more free, without protection.” Respondents indicated that renewed sexual freedom included having sex with multiple partners as well as being more adventurous in the sexual activities in which one engaged.
Another benefit of HIV vaccine adoption raised by participants was being able to have unprotected sex with people who were infected with HIV. As 1 participant said, “I have a friend that has a serodiscordant boyfriend; he would get vaccinated to be closer to each other,” suggesting that some HIV-serodiscordant couples may choose to forego condoms if the seronegative partner were vaccinated.
Female respondents noted that being immunized against HIV would enable them to conceive a child without worrying about HIV infection. The vaccine would allow one to “reproduce,” said a female participant. Respondents also suggested that being protected against HIV would yield psychologic benefits, such as reduced fear and anxiety during sexual encounters, which might be a motivator for HIV vaccine adoption. As 1 respondent stated, “Nowadays to have sex scares people, but if we are vaccinated, we would not be that fearful.” Another respondent said, “They wouldn’t have to worry.” Hence, vaccination would bring about “peace of mind.”
Respondents noted that they would be motivated to accept HIV vaccination if people or agencies that they trusted endorsed it, particularly a primary care physician. As 1 participant stated, “If my doctor, who I trust, recommended that I do it, I would do it.” Other participants indicated, “I trust the doctor’s opinion,” and “I prefer a man with a PhD” One youth respondent mentioned that he would trust endorsements of the HIV vaccine on the radio: “I would trust the radio, especially if it was on 92.3—The Beat. I would trust the radio. That’s me.”
Some participants construed vaccines in general as making one healthier. In response to reasons for HIV vaccine uptake, 1 participant answered, “to be healthy.” Along these lines, another respondent stated, “I would take the vaccine because I want to stay alive as long as I can.” Others related HIV vaccines to infant immunizations, which they perceived as health promoting. Some statements revealed confusion about the difference between vaccines and drug therapies, although respondents may have been aware of discussions of therapeutic HIV vaccines: “My friends and I would do it because we are already infected and we want a cure.” Accordingly, making oneself healthier in general, rather than strictly preventing disease, and treating HIV disease were other potential motivators for HIV vaccine adoption.
This study is among the first to explore concerns, motivators, and intentions in regard to adoption of post–efficacy trial HIV vaccines among adults at elevated risk for HIV infection. With insufficient uptake, even highly efficacious vaccines may fail to control the AIDS pandemic. The present findings suggest that HIV vaccine uptake is not guaranteed among high-risk communities. Of particular concern, these adults at elevated risk for HIV infection, 70% of whom were ethnic minorities, indicated reluctance to accept partially efficacious HIV vaccines, compounded by misunderstandings about HIV vaccines, fear of vaccine-induced HIV infection, and mistrust of government-sponsored research. Initial preventive HIV vaccines, however, are likely to be only partially efficacious.45 Because lower efficacy demands proportionately greater uptake to achieve vaccine effectiveness at the population level, it is vital to understand factors associated with vaccine uptake among the most important potential consumers of HIV vaccines.
In addition to concerns about vaccine-induced HIV infection, participants expressed fears about vaccine-induced HIV seropositivity and were confused and skeptical about a test to distinguish a vaccine-induced immune response from actual HIV infection. Social side effects of testing HIV positive, including difficulties in getting medical insurance, employment discrimination, and, particularly among Latinos, immigration problems, were also raised as concerns. Fear of vaccine-induced HIV infection31 and concerns about less than perfect efficacy,31,33,34 have been raised as potential barriers to posttrial HIV vaccine adoption in surveys of Midwestern adolescents. The present study suggests that these concerns may be shared by adults at elevated risk for HIV.
The risks and social side effects of vaccine-induced HIV seropositivity have been noted among trial participants,46,47 up to 44% of whom have tested positive using standard assays,46 along with possible interventions (eg, a laminated National Institutes of Health card indicating vaccine trial participation and a call-in number to verify participants). The scale of the potential HIV testing issues that may ensue in a posttrial HIV vaccine scenario, even given the development of assays that distinguish vaccine-induced seropositivity from actual HIV infection, suggests the importance of interventions to mitigate the potential social risks to adopters of HIV vaccines. Given respondents’ concerns about testing HIV positive, such interventions may increase vaccine uptake.
The present investigation also raises concerns not heretofore addressed in the HIV vaccine acceptability literature. Participants in this largely low socioeconomic status, ethnic minority sample raised concerns about prohibitive costs and lack of access to an HIV vaccine even if it were available. One of the premises of this study was that vaccine availability does not presuppose adoption; participants invoked issues of access, a crucial link between availability and adoption, which may be especially relevant among low socioeconomic status, underinsured, ethnic minority populations. In addition to raising concerns about cost and access among disenfranchised populations, the present study suggests the importance of mirroring the sociodemographics of the HIV epidemic in samples for behavioral investigations of HIV vaccine acceptability and uptake.
Women, in particular, expressed concerns about potential teratogenic effects and reproductive difficulties associated with HIV vaccines as well as fear of passing vaccine-induced HIV infection to their unborn children. An additional domain that emerged among women was relationship concerns: the possible reactions of a male spouse to HIV vaccine availability and to the women’s adopting—or even mentioning—an HIV vaccine. Such interpersonal concerns and gender dynamics have not heretofore been raised in the inchoate literature on posttrial HIV vaccine adoption. Past investigations of condom use suggested that gender dynamics and sexual negotiation skills are vital components in women having their male partners use a condom.48,49 A potentially tremendous advantage of an HIV vaccine over a condom is precisely that it does not require interpersonal negotiation and implementation at each sexual encounter. Nonetheless, findings from our women’s focus groups suggest the importance of just such interpersonal negotiation in the face of their male partners’ possible resistance to either or both of their being vaccinated; the latter may be a barrier to HIV vaccine uptake among some women.
Although this study suggests that adults at risk for HIV infection may adopt a highly efficacious HIV vaccine, it simultaneously raises concerns about potential increases in sexual risk behaviors in response to vaccine uptake. Motivations for HIV vaccine uptake included protection against HIV infection and the ability to safely engage in unprotected sex. Participants also expressed a desire to dissociate sex from anxiety about contracting HIV. Accordingly, the present findings reinforce the need for HIV preventive interventions to be deployed in tandem with vaccine dissemination.36,50 Suboptimal uptake of partial efficacy HIV vaccines accompanied by increases in HIV risk behaviors has the paradoxical potential to exacerbate the epidemic.51,52
Although the motivation of increased sexual freedom was related to vaccine adoption intentions, parallel intentions in terms of dispensing with safer injection guidelines were not as apparent. For one, several injection drug users cited fear of hepatitis C as a motivator to practice safer needle use even after adopting an efficacious HIV vaccine. An important caveat, however, is that all the injection drug users in the present study were attendees at needle exchange programs, who might be more motivated to engage in preventive behaviors than injection drug users in general. It is also noteworthy that some of the same injection drug users who indicated intentions to continue safer needle use nonetheless reported greater likelihood of engaging in unprotected sex after adopting an HIV vaccine. The need to reinforce safer sex, in addition to safer injection guidelines, is evident in tailoring preventive interventions for injection drug users.
Participants’ ambivalence in their adoption intentions regarding hypothetical HIV vaccines was expressed in a “wait and see” approach: refrain from immediate uptake once a vaccine becomes available and see if others adopt the vaccine before deciding whether to be vaccinated oneself. Bandwagoning, a concept in the general vaccine literature,53,54 aptly characterizes the attitudes expressed in the present study: individuals may wait until they perceive acceptance by others, perhaps presuming that others have done the necessary deliberation to make a wise choice, before accepting HIV vaccination.
Ambivalence about HIV vaccine uptake and the variety of consumer concerns raised in the present study, along with the context of suboptimal uptake across immunizations for existing vaccine-preventable diseases, suggest a need for interventions to facilitate the uptake of future U.S. FDA–approved HIV vaccines among communities at elevated risk for HIV infection. Formative research to identify concerns, motivations, and adoption intentions among important potential consumers of HIV vaccines may facilitate the design of successful empirically based interventions.55 Although the present findings suggest that these divergent communities shared in many vaccine concerns, specific issues arose in each community as well. Further research to assess differential motivators and concerns in regard to HIV vaccine uptake among diverse communities at risk may enable the design of population-specific interventions to increase vaccine uptake and prevent risk behavior increases.
Notwithstanding our findings, the present study has several limitations. Intentions to adopt hypothetical HIV vaccines may not translate into actual behavior. The expressed “wait and see” approach to HIV vaccine uptake, for example, is reflective of present intentions rather than future behavior. A related limitation is that lay participants may not be able to understand or reasonably comment on hypothetical HIV vaccines. First, the primary focus of this investigation was not to quantify adoption intentions but to elicit an array of consumer attitudes, concerns, and motivators regarding HIV vaccines and their adoption. Second, we consulted immunologists and HIV vaccine scientists in creating questions on hypothetical vaccines so, to the extent possible, the parameters (eg, efficacy) and values (eg, 50%) we raised map onto projected HIV vaccine products. Third, we began focus groups with discussions of existing vaccines, which all participants had experienced; this helped to foster an understanding of (hypothetical) HIV vaccines, and participants did raise a variety of reasonable concerns and motivators in regard to HIV vaccine uptake. Fourth, suboptimal uptake of existing vaccines, even more so among high-risk and ethnic minority individuals, suggests that suboptimal uptake of HIV vaccines is a likely scenario; thus, our findings of ambivalence and numerous concerns regarding HIV vaccine uptake seem to be well supported. Last, a recent meta-analysis56 reported a modest relationship (r = 0.45) between intentions and behavior in regard to condom use, another HIV preventive measure; the intention–behavior correlation in the case of HIV vaccine uptake may be higher given that condom use invokes 2 persons’ intentions and behavior and interpersonal interaction (although our findings suggest interpersonal concerns may persevere, particularly among women, in regard to HIV vaccine uptake).
Other limitations exist because of the focus group method. Group process may at times be problematic with 1 person dominating the group. In addition, concerns may arise in the group context that individuals otherwise may not have raised themselves. Facilitators were experienced in managing group dynamics, and the study protocol prompted the facilitator at every question to give all participants the opportunity to talk. Still, group process may influence the data, which may not accurately reflect each individual’s concerns. Our purpose was not to rank or quantify individual concerns, however, but to elicit and explore an array of consumer concerns in regard to hypothetical HIV vaccines among relatively homogeneous groups. In addition to its limitations, group process presents a unique opportunity to elicit in-depth reactions and to replicate some of the decision-making processes around actual vaccine adoption. Although in part a private decision, vaccine adoption occurs within the larger social context; research on adoption of existing vaccines suggests that individuals are influenced by the attitudes and behaviors of others.54
Finally, the small sample size as well as the participant selection process limits the ability to generalize our results to others. The purpose of this investigation was to elicit and explore reactions to hypothetical HIV vaccines among select consumers at risk for HIV rather than to quantify and generalize our findings to all persons at risk. We used a venue-based sampling approach targeting high-risk settings, recruited participants across 7 different venues of 3 broad types, and successfully enrolled a diverse sample, however, in an attempt to increase the breadth of our exploration.
This investigation suggests a variety of concerns and fears in regard to potential uptake of U.S. FDA–approved HIV vaccines among diverse communities at elevated risk for HIV infection. Nevertheless, many of the concerns elicited may be amenable to intervention to facilitate uptake of approved HIV vaccines. The likelihood of risk behavior increases subsequent to HIV vaccine availability among communities with high HIV seroprevalence rates, in particular given the prospect that initial vaccines may be only partially efficacious, reinforces the importance of designing tailored preventive interventions to be delivered in tandem with HIV vaccines to render vaccines effective in controlling the AIDS pandemic.
The authors thank the following colleagues for helpful feedback and support: Peter Anton, Ned Bayrd, Sally Blower, William Cunningham, Faith Landsman, Mary Jane Rotheram, David Wood, and Gail Wyatt; Danielle Seiden, and Lisa Kakinami for their assistance in preparing the manuscript; and 2 anonymous reviewers for constructive feedback. The authors also gratefully acknowledge the participation of the study volunteers and sites.
1. Esparza J, Chang ML, Widdus R, et al. Estimation of “needs” and “probable uptake” for HIV
/AIDS preventive vaccines based on possible policies and likely acceptance (a WHO/UNAIDS/IAVI study). Vaccine
2. Johnston MI, Flores J. Progress in HIV vaccine
development. Curr Opin Pharmacol.
3. Institute of Medicine. Calling the Shots: Immunization Finance Policies and Practices. Washington, DC: National Academies Press; 2000.
4. Zimmerman RK, Ball JA. Vaccinations in adults: missed opportunities. Am Fam Physician
. September 15, 1998.
5. U.S. Department of Health and Human Services. Healthy People 2010, McLean, VA: International Medical Publishing, Inc. 2001.
6. National Center for Health Statistics. Healthy People 2000 final review. Hyattsville, MD: Public Health Service. 2001.
7. Centers for Disease Control and Prevention. Vaccination levels among Hispanics and non-Hispanic whites aged ≥65 years—Los Angeles County, California, 1996. MMWR Morb Mortal Wkly Rep
8. Marin MG, Johanson WG Jr, Salas-Lopez D. Influenza vaccination among minority populations in the United States. Prey Med
9. Herek GM, Capitanio JP. AIDS stigma and sexual prejudice. Am Behav Sci
10. Herek GM, Capitanio JP, Widaman KF. HIV
-related stigma and knowledge in the United States: prevalence and trends, 1991–1999. Am J Public Health
11. Gamble VN. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health
12. Guinan ME. Black communities’ belief in “AIDS as genocide”: a barrier to overcome for HIV
prevention. Ann Epidemiol
13. Thomas SB, Quinn SC. The Tuskegee Syphilis Study, 1932 to 1972: implications for HIV
education and AIDS risk education programs in the black community. Am J Public Health
14. Andersen R, Bozzette S, Shapiro M, et al. Access of vulnerable groups to antiretroviral therapy among persons in care for HIV
disease in the United States. HCSUS Consortium. HIV
Cost and Services Utilization Study. Health Serv Res
15. Cunningham WE, Markson LE, Andersen RM, et al. Prevalence and predictors of highly active antiretroviral therapy use in patients with HIV
infection in the United States. HCSUS Consortium. HIV
Cost and Services Utilization. J Acquir Immune Defic Syndr
16. Crystal S, Sambamoorthi U, Merzel C. The diffusion of innovation in AIDS treatment: zidovudine use in two New Jersey cohorts. Health Serv Res
17. Gifford AL, Cunningham WE, Heslin KC, et al. Participation in research and access to experimental treatments by HIV
-infected patients. N Engl J Med
18. Bartholow BN, MacQueen KM, Douglas JM Jr, et al. Assessment of the changing willingness to participate in phase III HIV vaccine
trials among men who have sex with men. J Acquir Immune Defic Syndr Hum Retrovirol
19. Celentano DD, Beyrer C, Natpratan C, et al. Willingness to participate in AIDS vaccine
trials among high-risk populations in northern Thailand. AIDS
20. Gross M, Seage GR, Mayer KH, et al. Interest among gay/bisexual men in greater Boston in participating in clinical trials of preventive HIV
vaccines. J Acquir Immune Defic Syndr Hum Retrovirol
21. Jenkins RA, Temoshok LR, Virochsiri K. Incentives and disincentives to participate in prophylactic HIV vaccine
research. J Acquir Immune Defic Syndr Hum Retrovirol
22. Jenkins RA, Torugsa K, Markowitz LE, et al. Willingness to participate in HIV
trials among young Thai men. Sex Transm Infect
23. Koblin BA, Heagerty P, Sheon A, et al. Readiness of high-risk populations in the HIV
Network for Prevention Trials to participate in HIV vaccine
efficacy trials in the United States. AIDS
24. MacQueen KM, Buchbinder S, Douglas JM, et al. The decision to enroll in HIV vaccine
efficacy trials: concerns elicited from gay men at increased risk for HIV
infection. AIDS Res Hum Retroviruses
. 1994;10(Suppl 2):S261–S264.
25. McGrath JW, George K, Svilar G, et al. Knowledge about vaccine
trials and willingness to participate in an HIV
study in the Ugandan military. J Acquir Immune Defic Syndr
26. Perisse AR, Schechter M, Moreira RI, et al. Willingness to participate in HIV vaccine
trials among men who have sex with men in Rio de Janeiro, Brazil. Projeto Praca Onze Study Group. J Acquir Immune Defic Syndr
27. Strauss RP, Sengupta S, Kegeles S, et al. Willingness to volunteer in future preventive HIV vaccine
trials: issues and perspectives from three U.S. communities. J Acquir Immune Defic Syndr
28. UNAIDS/WHO. AIDS epidemic update: December 2001. Available at: http://www.who.int/hiv/facts/en/isbn9291731323.pdf.
Accessed March 29, 2004.
29. Vlahov D, Astemborski J, Solomon L, et al. Interest in HIV
vaccines among injection drug users in Baltimore, Maryland. AIDS Res Hum Retroviruses
. 1994;10(Suppl 2):S265–S268.
30. Gagnon MP, Godin G. Young adults and HIV vaccine
: determinants of the intention of getting immunized. Can J Public Health
31. Liau A, Zimet GD, Fortenberry JD. Attitudes about human immunodeficiency virus immunization: the influence of health beliefs and vaccine
characteristics. Sex Transm Dis
32. Liau A, Zimet G. Undergraduates’ perception of HIV
immunization: attitudes and behaviours as determining factors. Int J STD AIDS
33. Liau A, Zimet GD. The acceptability of HIV
immunization: examining vaccine
characteristics as determining factors. AIDS Care
34. Zimet GD, Blythe MJ, Fortenberry JD. Vaccine
characteristics and acceptability of HIV
immunization among adolescents. Int J STD AIDS
35. Zimet GD, Liau A, Fortenberry VD. Health beliefs and intention to get immunized for HIV
. J Adolesc Health
36. Webb PM, Zimet GD, Mays R, et al. HIV
immunization: acceptability and anticipated effects on sexual behavior among adolescents. J Adolesc Health
37. Zimet G, Fortenberry J, Blythe M. Adolescents’ attitudes about HIV
immunization. J Pediatr Psychol.
38. Centers for Disease Control and Prevention. HIV
/AIDS among racial/ethnic minority men who have sex with men—United States, 1989–1998. MMWR Morb Mortal Wkly Rep.
39. Diamant AL, Hays RD, Morales LS, et al. Delays and unmet need for health care among adult primary care patients in a restructured urban public health system. Am J Public Health.
40. Frankel MR, Shapiro MF, Duan N, et al. National probability samples in studies of low-prevalence diseases. Part II: designing and implementing the HIV
cost and services utilization study sample. Health Serv Res
41. Singleton R, Straits BC. Approaches to Social Research.
3rd ed. New York: Oxford University Press; 1999.
42. Morgan DL. The Focus Group Guidebook
. Thousand Oaks, CA: Sage Publications; 1998.
43. Strauss A, Corbin C. Basics of Qualitative Research: Grounded Theory Procedures and Techniques
. Newbury Park, CA: Sage Publications; 1990.
44. Glaser B, Strauss A. The Discovery of Grounded Theory.
Chicago, IL: Aldine; 1967.
45. Levy J. What can be achieved with an HIV vaccine
46. Belshe RB, Clements ML, Keefer MC, et al. Interpreting HIV
serodiagnostic test results in the 1990s: social risks of HIV vaccine
studies in uninfected volunteers. NIAID AIDS Vaccine
Clinical Trials Group. Ann Intern Med
47. Haynes BF. Scientific and social issues of human immunodeficiency virus vaccine
48. Crosby RA, DiClemente RJ, Wingood GM, et al. Condom use and correlates of African American adolescent females’ infrequent communication with sex partners about preventing sexually transmitted diseases and pregnancy. Health Educ Behav
49. Wingood GM, DiClemente RJ. Gender-related correlates and predictors of consistent condom use among young adult African-American women: a prospective analysis. Int J STD AIDS
50. Future access to HIV
vaccines. Report from a WHO-UNAIDS Consultation, Geneva, October 2–3, 2000. AIDS
51. Blower SM, McLean AR. Prophylactic vaccines, risk behavior change, and the probability of eradicating HIV
in San Francisco. Science
52. Halloran ME, Longini IM Jr, Haber MJ, et al. Exposure efficacy and change in contact rates in evaluating prophylactic HIV
vaccines in the field. Stat Med
53. Ball LK, Evans G, Bostrom A. Risky business: challenges in vaccine
risk communication. Pediatrics
54. Hershey JC, Asch DA, Thumasathit T, et al. The roles of altruism, free riding, and bandwagoning in vaccination decisions. Organ Behav Hum Decis Process
55. Andreasen AR. Marketing Social Change: Changing Behavior to Promote Health, Social Development, and the Environment
. San Francisco, CA: Jossey-Bass; 1995.
56. Albarracin D, Johnson BT, Fishbein M, et al. Theories of reasoned action and planned behavior as models of condom use: a meta-analysis. Psychol Bull.