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HIV vaccine efficacy trials require the enrolment of large numbers of HIV-negative individuals and thus it is necessary to engage with communities where HIV incidence is high. We identify some of the caveats and pitfalls associated with researching community engagement in the context of HIV vaccine trials. These are as follows: the lack of consensus of what community engagement is and how it is practiced, the sometimes paradoxical role of community advisory boards as community representatives and challenges associated with information dissemination in communities. We identify a set of considerations for community engagement practitioners, trial investigators and social scientists when conducting community engagement.

In Taiwan, men who have sex with men (MSM) are at disproportionate risk of HIV infection. We examined awareness and acceptability of future HIV vaccines. From July to August 2014, we conducted a cross-sectional survey with MSM recruited through community-based organizations (CBOs) in 2 cities. Among 200 participants (mean age, 27.6 years), half reported multiple partners and one-third condomless anal sex (past 3 months); 12% were HIV-positive. Traditional Chinese medicine (TCM) use was reported by 42.7%. Over two-thirds (69.0%) were aware of HIV vaccine research, but less than half (43.8%) would accept an HIV vaccine if available. In multivariable analysis, higher educational attainment, >5 sex partners, and TCM use were positively associated with HIV vaccine awareness. Culturally informed HIV vaccine preparedness in Taiwan may be supported by a complementary approach to TCM and HIV prevention technologies, tailoring information for MSM with lower education and targeting those at high risk through gay-identified CBOs.

Trust is a key element of high-quality stakeholder relations, which are themselves essential for the success of HIV vaccine trials. Where trust is absent, community stakeholders might not volunteer to become involved in key trial activities, and potential participants might not volunteer for enrollment. We explored site staff and Community Advisory Board (CAB) members' experiences of trust/mistrust among community members and potential participants. We analyzed 10 focus group discussions with site staff and CAB members at two active South African HIV vaccine trial sites. We report on key characteristics perceived to contribute to the trustworthiness of communicators, as well as factors associated with mistrust. Attributes associated with trustworthy communicators included shared racial identity, competence, and independence (not being "captured"). Key foci for mistrust included explanations about site selection, stored samples, vaccination, and Vaccine Induced Sero-Positivity (VISP). Our findings suggest that community members' trust is not necessarily global, in which trials are trusted or not; rather, it appears fairly nuanced and is impacted by various perceived attributes of communicators and the information they provide. We make recommendations for clinical trial site stakeholders invested in building trust and for future research into trust at these sites.

There has not been enough study of the processes by which site staff help participating community members and potential participants to understand complicated concepts for HIV vaccine trials. This article describes strategies reported in six focus group discussions with Community Advisory Board members, educators, and consent counselors at an active HIV vaccine trial site in South Africa. Thematic analysis identified a considerable range of strategies, and findings suggest that such staff do not only try to promote understanding of critical information but also try to build trust in communicated information, to respect cultural differences, and to promote voluntariness. Findings also suggest occasional tensions between these implicit goals. Actual engagement and consent encounters at HIV vaccine trial sites should be observed, recorded, and analyzed; and the relationship between practices and valued outcomes should be assessed. These efforts may help to make consent-related encounters as "potent" as possible given finite resources.

A substantial gap exists between widespread acknowledgement of the importance of incorporating cultural sensitivity in biomedical HIV prevention trials and empirical evidence to guide the operationalization of cultural sensitivity in these trials. We conducted a systematic literature search and qualitative meta-synthesis to explore how culture is conceptualized and operationalized in global biomedical HIV prevention trials. Across 29 studies, the majority (n = 17) were conducted in resource-limited settings. We identified four overarching themes: (1) semantic cultural sensitivity - challenges in communicating scientific terminology into local vernaculars; (2) instrumental cultural sensitivity - understanding historical experiences to guide tailoring of trial activities; (3) budgetary, logistical, and personnel implications of operationalizing cultural sensitivity; and (4) culture as an asset. Future investigations should address how sociocultural considerations are operationalized across the spectrum of trial preparedness, implementation, and dissemination in particular sociocultural contexts, including intervention studies and evaluations of the effectiveness of methods used to operationalize culturally sensitive practices.

Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical engagement of community stakeholders in HIV vaccine trials and early terminations of several international pre-exposure prophylaxis trials have fueled the development of international guidelines, such as UNAIDS' good participatory practice (GPP). GPP aims to ensure that stakeholders are effectively involved in all phases of biomedical HIV prevention trials. We provide an overview of the six guiding principles in the GPP and critically examine them in relation to existing social and behavioral science research. In particular, we highlight the challenges involved in operationalizing these principles on the ground in various global contexts, with a focus on low-income country settings. Increasing integration of social science in biomedical HIV prevention trials will provide evidence to advance a science of community stakeholder engagement to support ethical and effective practices informed by local realities and sociocultural differences.

Introduction: Men who have sex with men (MSM) are at disproportionately high risk for HIV in India and would benefit greatly from a safe and effective HIV vaccine. We assessed willingness to participate (WTP) in HIV vaccine trials and the impact of various trial characteristics on WTP among MSM in Mumbai and Chennai., Methods: We used venue-based time-space sampling to recruit MSM at cruising sites and drop-in centers at community-based organizations. Structured survey interviews assessed sociodemographics, WTP and the impact of 10 trial characteristics on WTP. We tested for differences in WTP by sociodemographics and trial characteristics, and sociodemographic differences in the impact of trial characteristics on WTP., Results: Among 400 participants (median age=25 years), 46.9% identified as kothi, 40.0% panthi/double-decker, 13.0% gay/bisexual; 29.0% had primary school education or less; and 40.0% had monthly income <=5000 INR (∼3USD/day). Overall, 48.1% reported being definitely willing to participate. Posttrial availability of an efficacious vaccine was the highest rated (90.98 on 100-point scale) trial characteristic, followed by availability of free medical treatment (90.79), life insurance (89.84) and side effects (79.81). Distance to the trial site, side effects, financial incentive, life insurance and free medical care had significant impacts on WTP, with differential importance of trial characteristics by sexual identity, education, income and living arrangement., Conclusion: The prioritization of trial-related financial and healthcare provisions, including access to an efficacious vaccine posttrial, among MSM in India indicates the importance of trials providing such services, as well as the value of formative research in identifying key concerns among participating communities in resource-limited settings. The significant impact of trial characteristics on WTP suggests that providing trial benefits deemed fair and important, addressing logistical concerns, and supporting educational interventions to mitigate vaccine fears may support recruitment of MSM in India in fairly and ethically conducted HIV vaccine trials., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Decade-long delays in successful implementation of Hepatitis B vaccines and ongoing obstacles in HPV vaccine roll-out suggest the importance of an implementation science approach to prepare for the effective translation of future HIV vaccines from clinical trials into routine practice. The objective of this study was to test HIV vaccine attitude items to develop reliable scales and to examine their association with HIV vaccine acceptability., Methods: HIV vaccine attitude items were assessed as part of the L.A. VOICES survey, a large-scale study conducted among underserved residents of Los Angeles, to identify factors that may influence HIV vaccine acceptability. Participants (n=1225) were randomly selected from public STD clinics, needle exchange sites and Latino community clinics using three-stage, venue-based time space sampling., Results: Exploratory factor analysis across 20 items revealed four distinct factors - mistrust, HIV vaccine social concerns, risk compensation, and altruistic vaccination - with acceptable reliability coefficients for each subscale (Cronbach's α range 0.61-0.84). We found no significant differences in reliability by gender or by vaccine acceptability. Risk compensation (odds ratio (OR)=1.49; 95% CI=[1.18, 1.89]; p=0.001) and altruistic vaccination (OR=1.40; 95% CI=[1.14, 1.71]; p=0.001) were significantly and positively associated with HIV vaccine acceptability., Conclusions: We identified four HIV vaccine attitude scales with sound internal reliability parameters. In the aftermath of the first candidate vaccine to demonstrate efficacy against HIV infection, these scales may be helpful in bridging expectable research-to-practice gaps in future HIV vaccine dissemination among populations at risk. As HIV vaccine trials progress in the United States and globally, these measures also may be useful as a tool to assess and facilitate effective responses to community concerns about HIV vaccine trials and to target interventions to support recruitment and mitigate risk compensation., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Compulsory vaccination is a frequently implemented policy option for ensuring comprehensive vaccine coverage. Ongoing controversies around human papillomavirus vaccine dissemination, and suboptimal coverage, suggest the value of assessing acceptability of compulsory vaccinations-particularly among likely target populations-in advance of their public availability to support evidence-informed interventions. With the first HIV vaccine to demonstrate partial efficacy in a large-scale clinical trial, we examined individual characteristics and attitudes associated with support for compulsory HIV vaccination policy among a diverse, representative sample of adults attending probable HIV vaccine dissemination venues in a large urban county. Participants were recruited using three-stage probability sampling from likely venues for future HIV vaccine dissemination. We used Audio-CASI to administer a 60-min structured questionnaire. Items included endorsement of compulsory HIV vaccination policy, sociodemographic characteristics, injecting drug use, vaccine attitudes and perceived HIV risk. Among 1,225 participants (mean age = 36.8 years; 55.6 % males, 37.6 % non-English speaking Hispanic, 78.8 % heterosexual, 25.7 % injection drug users), almost half (48.2 %) endorsed a compulsory HIV vaccination policy. Non-English speaking Hispanics compared to whites, participants with less than high school education, higher positive vaccine attitude scores and higher perceived HIV risk were significantly more likely, and people who inject drugs significantly less likely to endorse compulsory HIV vaccination. Public health interventions to promote positive vaccine attitudes and accurate perceptions of HIV risk among vulnerable populations, and strategies tailored for people who inject drugs, may build support for compulsory HIV vaccination policy and promote broad HIV vaccine coverage.

Objectives: Black women in Canada are at disproportionately high risk for HIV. We assessed HIV vaccine acceptability and correlates of acceptability among Black women from African and Caribbean communities in Toronto., Methods: "Sisters, Daughters, Mothers, and Aunties" was a community-based research project. Black women of African and Caribbean descent were recruited using venue-based sampling across diverse community organizations in Toronto. We used a structured questionnaire to collect data on socio-demographic characteristics and acceptability of 8 future HIV vaccines, each defined by a set of 7 dichotomous attributes. Conjoint analysis was used to quantify the relative impact of vaccine attributes on acceptability, with multiple regression to adjust for socio-demographic characteristics associated with overall acceptability., Results: Mean vaccine acceptability was 58.8 (SD=17.2) on the 100-point scale. Efficacy had the greatest impact on acceptability, followed by side effects, cost, duration of protection, and number of doses. Acceptability of a high (99%) efficacy vaccine (70.1/100) was significantly greater than for a 50% efficacy vaccine (47.6/100). Vaccine acceptability was significantly higher among women of Caribbean versus African descent, ever married versus single women, and women with full-time versus part-time employment., Conclusions: Black women in Toronto indicated a modest level of acceptability for future HIV vaccines. Educational interventions that address the benefits of partially efficacious vaccines and clearly explain potential side effects, as well as vaccine cost subsidies may promote HIV vaccine uptake. Differences in acceptability within Black communities suggest that tailored multi-level interventions may mitigate barriers to uptake.

This paper estimates the marginal willingness-to-pay for attributes of a hypothetical HIV vaccine using discrete choice modeling. We use primary data from 326 respondents from Bangkok and Chiang Mai, Thailand, in 2008-2009, selected using purposive, venue-based sampling across two strata. Participants completed a structured questionnaire and full rank discrete choice modeling task administered using computer-assisted personal interviewing. The choice experiment was used to rank eight hypothetical HIV vaccine scenarios, with each scenario comprising seven attributes (including cost) each of which had two levels. The data were analyzed in two alternative specifications: (1) best-worst; and (2) full-rank, using logit likelihood functions estimated with custom routines in Gauss matrix programming language. In the full-rank specification, all vaccine attributes are significant predictors of probability of vaccine choice. The biomedical attributes of the hypothetical HIV vaccine (efficacy, absence of VISP, absence of side effects, and duration of effect) are the most important attributes for HIV vaccine choice. On average respondents are more than twice as likely to accept a vaccine with 99% efficacy, than a vaccine with 50% efficacy. This translates to a willingness to pay US$383 more for a high efficacy vaccine compared with the low efficacy vaccine. Knowledge of the relative importance of determinants of HIV vaccine acceptability is important to ensure the success of future vaccination programs. Future acceptability studies of hypothetical HIV vaccines should use more finely grained biomedical attributes, and could also improve the external validity of results by including more levels of the cost attribute., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: Informed consent based on comprehension of potential risks and benefits is fundamental to the ethical conduct of clinical research. We explored mental models of candidate HIV vaccines and clinical trials that may impact on the feasibility and ethics of biomedical HIV prevention trials among men who have sex with men (MSM) in India., Methods: A community-based research project was designed and implemented in partnership with community-based organizations serving MSM in Chennai and Mumbai. We conducted 12 focus groups (n=68) with diverse MSM and 14 key informant interviews with MSM community leaders/service providers using a semi-structured interview guide to explore knowledge and beliefs about HIV vaccines and clinical trials. Focus groups (60-90 minutes) and interviews (45-60 minutes) were conducted in participants' native language (Tamil in Chennai; Marathi or Hindi in Mumbai), audio-taped, transcribed and translated into English. We explored focus group and interview data using thematic analysis and a constant comparative method, with a focus on mental models of HIV vaccines and clinical trials., Results: A mental model of HIV vaccine-induced seropositivity as "having HIV" resulted in fears of vaccine-induced infection and HIV stigma. Some participants feared inactivated vaccines might "drink blood" and "come alive". Pervasive preventive misconception was based on a mental model of prevention trials as interventions, overestimation of likely efficacy of candidate vaccines and likelihood of being assigned to the experimental group, with expectations of protective benefits and decreased condom use. Widespread misunderstanding and lack of acceptance of placebo and random assignment supported perceptions of clinical trials as "cheating". Key informants expressed concerns that volunteers from vulnerable Indian communities were being used as "experimental rats" to benefit high-income countries., Conclusions: Evidence-informed interventions that engage with shared mental models among potential trial volunteers, along with policies and funding mechanisms that ensure local access to products that demonstrate efficacy in trials, may support the safe and ethical implementation of HIV vaccine trials in India.

Concerns about the impact of risk compensation on advances in biomedical human immunodeficiency virus (HIV) prevention technologies have been documented. We conducted an exploratory qualitative study using focus group discussions with young South African men and women (aged 18 to 24 years) to explore perceptions of risk compensation with regard to a hypothetical posttrial HIV vaccine. During the discussions, participants expressed their disquiet about the potential for risk compensation and the manner in which this might manifest among young people. Discussions specifically focused on reductions in condom use, an increase in multiple partners, and increased frequency of sex. The discussions also revealed contradictory feelings about HIV vaccines: appreciation for their development tempered by concerns about loss of control and undermining morality. Women were particularly concerned with the possibility of increased partner concurrency and infidelity. We suggest that concerns in HIV vaccine target populations about the impact of possible risk compensation be incorporated into strategies for vaccine introduction once vaccines move from the hypothetical to reality.

Engaging consumers in prospectively shaping strategies for dissemination of health-care innovations may help to ensure acceptability. We examined the feasibility of using conjoint analysis to assess future HIV vaccine acceptability among three diverse communities: a multiethnic sample in Los Angeles, CA, USA (n = 143); a Thai resident sample in Los Angeles (three groups; n = 27) and an Aboriginal peoples sample in Toronto (n = 13). Efficacy had the greatest impact on acceptability for all three groups, followed by cross-clade protection, side-effects and duration of protection in the Los Angeles sample; side-effects and duration of protection in the Thai-Los Angeles sample; and number of doses and duration of protection in the Aboriginal peoples-Toronto sample. Conjoint analysis provided insights into universal and population-specific preferences among diverse end users of future HIV vaccines, with implications for evidence-informed targeting of dissemination efforts to optimize vaccine uptake.

A safe and efficacious preventive HIV vaccine would be a tremendous asset for low- and middle-income country (LMIC) settings, which bear the greatest global impact of AIDS. Nevertheless, substantial gaps between clinical trial efficacy and real-world effectiveness of already licensed vaccines demonstrate that availability does not guarantee uptake. In order to advance an implementation science of HIV vaccines centred on LMIC settings, we explored sociocultural and structural contexts of HIV vaccine acceptability among most-at-risk populations in Thailand, the site of the largest HIV vaccine trial ever conducted. Cross-cutting challenges for HIV vaccine uptake - social stigma, discrimination in healthcare settings and out-of-pocket vaccine cost - emerged in addition to population-specific barriers and opportunities. A 'social vaccine' describes broad sociocultural and structural interventions - culturally relevant vaccine promotion galvanised by communitarian norms, mitigating anti-gay, anti-injecting drug user and HIV-related stigma, combating discrimination in healthcare, decriminalising adult sex work and injecting drug use and providing vaccine cost subsidies - that create an enabling environment for HIV vaccine uptake among most-at-risk populations. By approaching culturally relevant social and structural interventions as integral mechanisms to the success of new HIV prevention technologies, biomedical advances may be leveraged in renewed opportunities to promote and optimise combination prevention.

Background: Recruitment of low- and middle-income country volunteers from most-at-risk populations in HIV vaccine trials is essential to vaccine development. In India, men who have sex with men (MSM) are at disproportionately high risk for HIV infection and an important population for trial recruitment. Investigations of willingness to participate (WTP) in HIV vaccine trials have focused predominantly on individual-level determinants. We explored multi-level factors associated with WTP among MSM in India., Methods: We conducted 12 focus groups (n = 68) with low socioeconomic MSM in Chennai and Mumbai, and 14 key informant interviews with MSM community leaders and service providers. Focus groups/interviews were recorded, transcribed and translated into English. Two bilingual investigators conducted thematic analysis using line-by-line coding and a constant comparative method, with member-checking by community representatives., Results: Factors associated with WTP were evidenced across the social ecology of MSM-social-structural: poverty, HIV-, sexual- and gender non-conformity stigma, institutionalized discrimination and government sponsorship of trials; community-level: endorsement by MSM community leaders and organizations, and fear of within-group discrimination; interpersonal: anticipated family discord, partner rejection, having financially-dependent family members and disclosure of same-sex sexuality; and individual-level: HIV vaccine trial knowledge and misconceptions, safety concerns, altruism and preventive misconception., Conclusion: Pervasive familial, community and social-structural factors characteristic of the Indian sociocultural context may complicate individual-focused approaches to WTP and thereby constrain the effectiveness of interventions to support recruitment and retention in HIV vaccine trials. Interventions to reduce stigma and discrimination against MSM and people living with HIV, capacity-building of MSM community organizations and transparent communications tailored to the knowledge and educational level of local communities may support meaningful engagement of MSM in HIV vaccine trials. Vigilance in providing fair but not excessive compensation and healthcare benefits and in mitigating preventive misconception are warranted to support ethical conduct of trials among MSM in India.

Community engagement is crucial to ongoing development and testing of sorely needed new biomedical HIV prevention technologies. Yet, negative trial results raise significant challenges for community engagement in HIV prevention trials, including the early termination of the Cellulose Sulfate microbicide trial and two Phase IIb HIV vaccine trials (STEP and Phambili). The present study aimed to explore the perspectives and experiences of civil society organization (CSO) representatives regarding negative HIV prevention trial results and perceived implications for future trials. We conducted in-depth interviews with 14 respondents from a broad range of South African and international CSOs, and analyzed data using thematic analysis. CSO representatives reported disappointment in response to negative trial results, but acknowledged such outcomes as inherent to clinical research. Respondents indicated that in theory negative trial results seem likely to impact on willingness to participate in future trials, but that in practice people in South Africa have continued to volunteer. Negative trial results were described as having contributed to improving ethical standards, and to a re-evaluation of the scientific agenda. Such negative results were identified as potentially impacting on funding for trials and engagement activities. Our findings indicate that trial closures may be used constructively to support opportunities for reflection and renewed vigilance in strategies for stakeholder engagement, communicating trial outcomes, and building research literacy among communities; however, these strategies require sustained resources for community engagement and capacity-building.

This study explored HIV vaccine acceptability and strategies for culturally appropriate dissemination among sexually diverse Aboriginal peoples in Canada, among those at highest HIV risk. We conducted four focus groups (n=23) with Aboriginal male (1) and female (1) service users, peer educators (1) and service providers (1) in Ontario, Canada. Transcripts were analysed with narrative thematic techniques from grounded theory, using NVivo. Participants' mean age was 37 years; about half (52%) were female, half (48%) Two-spirit or lesbian, gay or bisexual (LGB)-identified, 48% had a high-school education or less and 57% were unemployed. Vaccine uptake was motivated by community survival; however, negative HIV vaccine perceptions, historically based mistrust of government and healthcare institutions, perceived conflict between western and traditional medicine, sexual prejudice and AIDS stigma within and outside of Aboriginal communities, and vaccine cost may present formidable obstacles to HIV vaccine acceptability. Culturally appropriate processes of engagement emerged on individual levels (i.e., respect for self-determination, explanations in Native languages, use of modelling and traditional healing concepts) and community levels (i.e., leadership by Aboriginal HIV advocates and political representatives, identification of gatekeepers, and procuring Elders' endorsements). Building on cultural strengths and acknowledging the history and context of mistrust and social exclusion are fundamental to effective HIV vaccine dissemination.

Objectives: We investigated how persons from key populations at higher risk of HIV exposure interpreted the process and outcomes of the Step Study HIV-1 vaccine trial, which was terminated early, and implications for willingness to participate in and community support for HIV vaccine research., Methods: We used qualitative methods and a community-based approach in 9 focus groups (n = 72) among ethnically and sexually diverse populations and 6 semistructured key informant interviews in Ontario, Canada, in 2007 to 2008., Results: Participants construed social meaning from complex clinical and biomedical phenomena. Social representations and mental models emerged in fears of vaccine-induced infection, conceptualizations of unfair recruitment practices and increased risk behaviors among trial participants, and questioning of informed consent. Narratives of altruism and the common good demonstrated support for future trials., Conclusions: Public discourse on HIV vaccine trials is a productive means of interpreting complex clinical trial processes and outcomes in the context of existing beliefs and experiences regarding HIV vaccines, medical research, and historical disenfranchisement. Strategic engagement with social representations and mental models may promote meaningful community involvement in biomedical HIV prevention research.

The Step Study phase IIb HIV-1 vaccine trial was terminated early due to futility; subsequent analyses revealed increased susceptibility to HIV infection among a subset of test vaccine recipients. We conducted a mixed methods investigation, including a brief, self-administered baseline questionnaire and in-depth, semi-structured, 1-h interviews after unblinding, to explore experiences and perspectives among trial participants and key informants. Interviews were digitally recorded, transcribed, and analyzed using NVivo and thematic techniques. Forty-eight trial participants (46 gay/bisexual men) completed baseline surveys; 15 (14 gay/bisexual men) engaged in post-trial interviews. Participants indicated surprise and disappointment about the early trial termination and unexpected risks. Some articulated understanding the uncertainties of clinical trials, steadfast support and willingness to participate in the future; others reported greater risks than they deemed acceptable and unlikelihood of volunteering again. A few indicated mistrust of trial sponsors and ethics. Participants' most profound criticism was not about unexpected results, but perceived delays in unblinding and gaps in post-trial dissemination of information. Future HIV vaccine trials may benefit from increased emphasis on: (1) communication mechanisms among participants, investigators and trial sponsors, and (2) post-trial dissemination of information and psychosocial support., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Objective: To conduct a systematic review of the literature to examine HIV vaccine acceptability and factors impacting acceptability of future HIV vaccines., Design: Systematic review and meta-analysis of peer-reviewed articles that assessed HIV vaccine acceptability., Methods: We used a comprehensive search strategy across multiple electronic databases to locate original quantitative or qualitative studies that examined rates or correlates of HIV vaccine acceptability. We conducted meta-analysis on studies reporting correlates or predictors of HIV vaccine acceptability., Results: Twenty studies (n=7576) reported HIV vaccine acceptability ranging from 37.2 to 94.0 on a 100-point scale; weighted mean acceptability =65.6 (SD=21.1). Eleven studies compared HIV vaccine acceptability at high (80-95%) efficacy (mean =73.8; SD=9.2) versus moderate (50%) efficacy (mean =40.4; SD=20.2). Among 13 studies (n=5023) included in meta-analysis, efficacy and non 'risk group' membership had medium effect sizes, and pragmatic obstacles, cost, perceived susceptibility to HIV infection, side effects/safety concerns, fear of vaccines, perceived vaccine benefits, duration of protection, and ethnicity had small effect sizes on HIV vaccine acceptability., Conclusion: Public health strategies to promote the benefits of partial efficacy HIV vaccines and accurate HIV risk perceptions, and to dispel vaccine fears, along with structural interventions to subsidize vaccine costs and facilitate access, may increase future HIV vaccine uptake and, in turn, the effectiveness of HIV vaccines in controlling the epidemic.

Developing and disseminating a preventive HIV vaccine is a primary scientific and public health objective. However, little is known about HIV vaccine acceptability in the high-prevalence setting of South Africa- where young adults are likely to be targeted in early dissemination efforts. This study reports on six focus groups ( n = 42) conducted in 2007 with South Africans aged 18 to 24 years. A deductive framework approach is used to identify key motivators and barriers to future HIV vaccine uptake. Participants identify HIV testing, HIV stigma, mistrust of the health care system, and concerns about sexual disinhibition as barriers to vaccine uptake. For women, family members and friends are strong motivators for vaccine uptake, whereas men are more likely to see vaccines as an opportunity to stop using HIV prevention strategies such as condoms and partner reduction. Implications of these findings for developing HIV vaccine dissemination strategies and policy in South Africa are discussed.

Thailand, with the highest number of volunteers to have participated in preventive HIV-1 vaccine trials globally, may be an early adopter of HIV vaccines. We conducted a mixed methods investigation, including 30 in-depth interviews and a venue-based survey. We used a structured questionnaire including conjoint analysis and a fractional factorial experimental design to assess preventive HIV vaccine acceptability and risk compensation among 255 high-risk men who have sex with men (MSM) and transgenders (mean age=26.6 years). HIV vaccine acceptability ranged from 31.6 to 73.8 on a 100-point scale; mean=58.3 (SD=17.1). Vaccine-induced seropositivity (VISP) had the greatest impact on acceptability, followed by efficacy, side effects, duration of protection, out-of-pocket cost and social saturation. Over one-third (34.6%) reported intentions to increase post-vaccination risk behaviors in response to a highly efficacious HIV vaccine. Social and structural interventions to promote HIV vaccine uptake as a prosocial behavior, provide accessible assays to detect VISP, and subsidize vaccine costs, and support for uptake of partially efficacious vaccines in the context of combination prevention, will facilitate HIV vaccine dissemination in Thailand.

Objective: To assess HIV vaccine acceptability among high-risk adults in Los Angeles., Study Setting: Sexually transmitted disease clinics, needle/syringe exchange programs, Latino community health/HIV prevention programs., Study Design: Cross-sectional survey using conjoint analysis. Participants were randomly selected using three-stage probability sampling., Data Collection: Sixty-minute structured interviews. Participants rated acceptability of eight hypothetical vaccines, each with seven dichotomous attributes, and reported post-vaccination risk behavior intentions., Principal Findings: Participants (n=1164; 55.7 percent male, 82.4 percent ethnic minority, mean age=37.4 years) rated HIV vaccine acceptability from 28.4 to 88.6; mean=54.5 (SD=18.8; 100-point scale). Efficacy had the greatest impact on acceptability, followed by side effects and out-of-pocket cost. Ten percent would decrease condom use after vaccination., Conclusions: Findings support development of social marketing interventions to increase acceptability of "partial efficacy" vaccines, behavioral interventions to mitigate risk compensation, and targeted cost subsidies.

Existing knowledge and beliefs related to HIV vaccines provide an important basis for the development of risk communication messages to support future HIV vaccine dissemination. This study explored HIV vaccine mental models among adults from segments of the population disproportionately affected by HIV/AIDS. Nine focus groups were conducted with participants (N = 99; median age = 33 years; 48% female; 22% African American, 44% Latino, and 28% white) recruited from needle exchange sites, public clinics, and gay community centers in Los Angeles. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software. Mental models of HIV vaccines included live virus, side effects, complete protection (100% efficacy, lifetime protection, reduced anxiety about HIV/AIDS), and "high-risk groups." HIV vaccine risk communication to counter undue fears of vaccine-induced infection and side effects and to mitigate exaggerated expectations of a "magic bullet" may be vital to the effectiveness of first-generation HIV vaccines in controlling the AIDS epidemic.

This study examined HIV vaccine acceptability among immigrant Thai residents in Los Angeles, California. We combined a qualitative research method (focus groups) with an innovative market research method (conjoint analysis). Focus groups explored social issues, concerns, barriers and motivators associated with HIV vaccine acceptability. Conjoint analysis was used to assess preferences among eight hypothetical HIV vaccines with varying attribute profiles and the impact of various attributes on acceptability. Five main themes were identified in the focus groups regarding acceptance and utilization of preventive HIV vaccines: (1) vaccine characteristics, such as efficacy, physical side-effects and cost, (2) fear of a vaccine, (3) vaccine acceptability and optimism, (4) social and family responses and (5) behavioral disinhibition. Conjoint analysis revealed HIV vaccine acceptability ranging from 7.4 (SD = 19.4) to 85.2 (SD = 24.3) across eight hypothetical vaccines. The vaccine with the highest acceptability had the following attributes: 99% efficacy, no side-effects, 10 years of protection, protects against one sub-type, free, one dose and given by injection. Vaccine efficacy had the greatest impact on acceptability (51.4, p=.005), followed by side-effects (11.1, p=.005) and duration of protection (8.3, p=.005). Despite some apprehensions and concerns, Thai residents perceived an HIV vaccine as making an important contribution to society and to protecting oneself and one's family from HIV infection. Nevertheless, acceptability of a partially efficacious vaccine may be low, suggesting the need for tailored social marketing interventions that might emphasize a collectivistic rather than an individualistic focus. Assessing HIV vaccine acceptability using a mixed-method approach is feasible with Thai residents and should lend itself to HIV vaccine research with other Asian Pacific Islander populations in the US.

This investigation explored commonalities and differences in barriers and motivators to HIV vaccine trial participation and acceptability of future U.S. Food and Drug Administration (FDA)-approved HIV vaccines in order to identify implications of clinical trials for future HIV vaccine dissemination. Fifteen focus groups were conducted with 157 predominately ethnic minority and low income participants recruited using venue-based sampling in Los Angeles. Data were analyzed using narrative thematic analysis. Barriers and motivators in common across willingness to participate (WTP) in HIV vaccine trials and future HIV vaccine acceptability (e.g., concerns about vaccine-induced infection, false-positives, side effects, efficacy, mistrust and stigma) suggest clinical trials present significant opportunities to develop and evaluate empirically based interventions to support future HIV vaccine dissemination. Barriers specific to HIV vaccine acceptability (e.g., concerns about duration of protection, cross-clade protection, cost and access) also indicate the need for formative research focused specifically on future dissemination. Protection motivation, common to WTP and acceptability, highlights the need to provide and evaluate prevention counseling and education in clinical trials, which may form the basis of evidence-informed preventive interventions to be launched in tandem with dissemination of partial efficacy HIV vaccines.

The development of safe and efficacious preventive HIV vaccines offers the best long-term hope of controlling the AIDS pandemic. Nevertheless, suboptimal uptake of safe and efficacious vaccines that already exist suggest that HIV vaccine acceptability cannot be assumed, particularly among communities most vulnerable to HIV. The present study aimed to identify barriers and motivators to future HIV vaccine acceptability among low socioeconomic, ethnically diverse men and women in Los Angeles County. Participants completed a cross-sectional survey assessing their attitudes and beliefs regarding future HIV vaccines. Hypothetical HIV vaccine scenarios were administered to determine HIV vaccine acceptability. Two-sided t-tests were performed, stratified by gender, to examine the association between vaccine acceptability and potential barriers and motivators. Barriers to HIV vaccine acceptability differed between men and women. For women, barriers to HIV vaccine acceptability were related to their intimate relationships (p<0.05), negative experiences with health care providers (p<0.05) and anticipated difficulties procuring insurance (p<0.01). Men were concerned that the vaccine would weaken the immune system (p<0.005) or would affect their HIV test results (p<0.05). Motivators for women included the ability to conceive a child without worrying about contracting HIV (p<0.10) and support from their spouse/significant other for being vaccinated (p<0.10). Motivators for men included feeling safer with sex partners (p<0.05) and social influence from friends to get vaccinated (p<0.005). Family support for HIV immunization was a motivator for both men and women (p<0.10). Gender-specific interventions may increase vaccine acceptability among men and women at elevated risk for HIV infection. Among women, interventions need to focus on addressing barriers due to gendered power dynamics in relationships and discrimination in health care. Among men, education that addresses fears and misconceptions about adverse effects of HIV vaccination on health and the importance of vaccination as one component of integrated HIV prevention may increase vaccine acceptability.

Sustained recruitment over time of tens of thousands of clinical trial volunteers is essential to the development of safe and efficacious HIV vaccines. This study explored, in depth, reasons for declining to enroll among persons screened in as eligible for a Phase IIb prophylactic HIV vaccine trial. Thirteen non-enrollees completed a self-administered questionnaire; of those, 11 completed a 1-h follow-up interview. Interviews were transcribed verbatim and themes derived using narrative thematic analysis and NVivo software. Concerns about negative social consequences of false HIV-positive tests, trial uncertainties, side effects, double-blind assignment, trial duration, uncertain efficacy, behavioral disinhibition and stigma emerged as reasons for declining to enroll. Social, psychological and emotional dimensions of HIV vaccine trial participation--including false-positives and anticipated stigma and discrimination, possible impact on intimate relationships, and concerns about behavioral disinhibition--suggest that provision of voluntary trial-related psychosocial counseling, a trial ombudsperson, alternate trial sites, and systematic community engagement in trial planning, recruitment and evaluation may facilitate informed participation in safe and ethically conducted HIV vaccine trials.

Objectives: To assess willingness to participate (WTP) in hypothetical Phase III preventive HIV vaccine trials, and the impact of trial attributes on WTP, among low socioeconomic, ethnically diverse adults from communities at elevated risk for HIV infection., Method: Participants (n=123; median age=38; 69% male; 37% Latino; 14% African-American) were recruited in Los Angeles in 2003 using multi-site, venue-based sampling. WTP was assessed for eight hypothetical HIV vaccine trials that varied across seven dichotomous attributes, using a 2(7-4) fractional factorial experimental design. Individual-specific impact of vaccine trial attributes on WTP was estimated using within-individual ANOVA and then meta-analyzed across individuals., Results: Mean WTP for eight hypothetical vaccine trials ranged from 1.74 to 3.81 (1=highly unlikely, 5=highly likely). Lower WTP was associated with vaccine-induced infection risk (impact=0.88, p<0.0001), false HIV-positives (0.53, p<0.0001), no provision of free HIV medications (0.52, p<0.0001), and longer trial duration (0.27; p=0.0002)., Conclusion: HIV vaccine trial attributes may strongly influence WTP. Although existing candidate vaccines cannot cause HIV infection, perceptions of risk may impede WTP. Eliciting trial preferences and concerns prior to trial implementation may enable accommodation of participant preferences and support tailored interventions to address concerns and misconceptions to facilitate enrollment in safe and ethical trials among vulnerable communities.

Latinos are under-represented in HIV/AIDS medical research in the US. Although they are disproportionately impacted by HIV/AIDS, Latinos may be reluctant to participate in HIV vaccine trials. Three focus groups were conducted with 32 Spanish-speaking Latinos recruited from two community-based healthcare organizations in Los Angeles, California. A qualitative focus group interview guide was developed to explore concerns, motivators and intentions in regard to participation in HIV vaccine trials. Mistrust and fear of government emerged as important themes related to reluctance to participate in an HIV vaccine trial. Specific concerns regarding trial participation included: (1) fear of vaccine-induced HIV infection, (2) physical side effects, (3) stigma and (4) false-induced HIV-positive test results and their social repercussions. Motivators for enrolling in an HIV vaccine trial included: (1) incentives, (2) convenience of participating in a study, (3) sufficient and appropriate study information, (4) personal benefits and (5) altruism. Interventions to facilitate participation by Latinos in HIV vaccine trials should address mistrust and fear of government-sponsored HIV/AIDS medical research, increase access to and convenience of clinical trials, address fear of vaccine-induced infection, combat HIV/AIDS stigma and raise awareness of the relevance of HIV/AIDS to Latino communities.

HIV vaccines offer the best long-term hope of controlling the AIDS pandemic; yet, the advent of HIV vaccines will not ensure their acceptability. We conducted a cross-sectional survey (n=143), incorporating conjoint analysis, to assess HIV vaccine acceptability among participants recruited using multi-site (n=9), venue-based sampling in Los Angeles. We used a fractional factorial experimental design to construct eight hypothetical HIV vaccines, each with seven dichotomous attributes. The acceptability of each vaccine was assessed individually and then averaged across participants. Next, the impact of each attribute on vaccine acceptability was estimated for each participant using ANOVA and then analyzed across participants. Acceptability of the eight hypothetical HIV vaccines ranged from 33.2 (S.D. 34.9) to 82.2 (S.D. 31.3) on a 0-100 scale; mean=60.0 (S.D. 21.9). Efficacy had the greatest impact on acceptability (22.7; CI: 18.5-27.1; p<0.0001), followed by cross-clade protection (12.5; CI: 8.7-16.3, p<0.0001), side effects (11.5; CI: 7.4-15.5; p<0.0001), and duration of protection (6.1; CI: 3.2-9.0; p<.0001). Route of administration, number of doses and cost were not significant. Low acceptability of "partial efficacy" vaccines may present obstacles to future HIV vaccine dissemination. Educational and social marketing interventions may be necessary to ensure broad HIV vaccine uptake.

Background: Underrepresentation of ethnic minority communities limits the generalizability of HIV vaccine trial results. We explored perceived barriers and motivators regarding HIV vaccine trial participation among low-socioeconomic ethnic minority respondents at risk for HIV., Methods: Six focus group interviews were conducted using a semistructured interview guide. Participants (N = 58, mean age = 36 years, 37% female, and 56% Latino/a and 35% African American) were recruited using venue-based sampling in Los Angeles. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software., Results: Perceived barriers to HIV vaccine trial participation, in rank order, were (1) vaccine-induced HIV infection, (2) physical side effects, (3) uncertainty about vaccine efficacy, (4) uncertainty about other vaccine characteristics, (5) mistrust, (6) low perceived HIV risk, (7) study demands, (8) stigma, and (9) vaccine-induced HIV seropositivity. Motivators were (1) protection against HIV infection, (2) free insurance and/or medical care, (3) altruism, and (4) monetary incentives., Conclusions: Population-specific HIV vaccine trial recruitment and implementation strategies should address trial risks from a family perspective, cultural gender norms, mistrust, low perceived HIV risk, the importance of African-American and Latino/a community participation in HIV vaccine trials, and misconceptions about gaining protection against HIV infection. Increasing the cultural relevance of trial recruitment and implementation should facilitate the participation of Latinos/as and African Americans in HIV vaccine trials.

HIV vaccines offer the best long-term hope of controlling the AIDS pandemic. We explored HIV vaccine knowledge and beliefs among communities at elevated risk for HIV/AIDS. Participants (N=99; median age=33 years; 48% female; 22% African-American; 44% Latino; 28% white; 6% other) were recruited from seven high-risk venues in Los Angeles, California, using purposive, venue-based sampling. Results from nine focus groups revealed: 1) mixed beliefs and conspiracy theories about the existence of HIV vaccines; 2) hopefulness and doubts about future HIV vaccine availability; 3) lack of information about HIV vaccines; and 4) confusion about vaccines and how they work. Tailored HIV vaccine education that addresses the current status of HIV vaccine development and key vaccine concepts is warranted among communities at risk. Ongoing dialogue among researchers, public health practitioners and communities at risk may provide a vital opportunity to dispel misinformation and rumors and to cultivate trust, which may facilitate HIV vaccine trial participation and uptake of future HIV vaccines.

The purpose of this study is to explore perceived barriers and facilitators to the uptake of future U.S. Food and Drug Administration-approved HIV vaccines among women at elevated risk for HIV. We conducted four client focus groups (N = 41) and one focus group of women's health care professionals (N =9). Participants were recruited from diverse community agencies and health care clinics in Los Angeles using purposive, venue-based sampling. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software. Barriers to HIV vaccine uptake included fear of vaccine-induced HIV infection, reproductive side effects, injection concerns, gendered roles and power dynamics, HIV stigma, discrimination, affordability, and mistrust. The provision of affordable and accessible HIV vaccines, ideally through routine care, along with culturally tailored, gender-specific HIV vaccine intervention and policy, can ensure the full potential of HIV vaccines to empower women to protect themselves against HIV infection.

HIV vaccine availability does not guarantee uptake. Given suboptimal uptake of highly efficacious and already accessible vaccines in the United States, low vaccine coverage in the developing world, and the expectation that initial HIV vaccines will be only partially efficacious, the public health community will face formidable challenges in disseminating U.S. Food and Drug Administration (FDA)-approved HIV vaccines. HIV/AIDS stigma, fear of vaccine- induced HIV infection, social side effects of testing HIV-positive, and mistrust of government and research present additional obstacles to HIV vaccine dissemination. Increased risk behaviors because of HIV vaccine availability can undermine the effectiveness of partially efficacious vaccines in reducing HIV incidence. HIV vaccine efficacy trials also face significant challenges in recruitment of sufficient volunteers and possible increases in risk behaviors due to trial participation. Planning and designing interventions to facilitate successful recruitment for large-scale phase 3 efficacy trials is a vital step towards U.S. FDA-approved HIV vaccines. Rather than despair in the face of momentous HIV vaccine dissemination challenges, or presume unrealistically that vaccine uptake will ensue automatically and that risk behavior increases will not occur, let us deem the estimated 10-year window to an approved HIV vaccine as an opportunity to investigate and confront these challenges. A consumer research agenda founded on social marketing principles is needed to facilitate the design of empirically-based interventions tailored to the unique needs and preferences of specific segments of consumers. Social marketing interventions may increase future HIV vaccine uptake and clinical trial participation, and mitigate increases in HIV risk behaviors.

Background: Suboptimal uptake of existing vaccines, potential obstacles specific to HIV/AIDS stigma and mistrust, and marked health disparities suggest that it is vital to investigate consumer concerns, motivations, and adoption intentions regarding posttrial HIV vaccines before a vaccine is publicly available., Method: Nine focus groups were conducted with participants (n = 99; median age, 33 years; 48% female; 22% African American, 44% Latino, and 28% white) recruited from 7 high-risk venues in Los Angeles using purposive venue-based sampling. A semistructured interview guide elicited concerns, motivators, and adoption intentions regarding hypothetical U.S. Food and Drug Administration-approved HIV vaccines. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software., Results: Concerns included vaccine efficacy, vaccine-induced infection, vaccine-induced HIV seropositivity, side effects, cost/access, trustworthiness, and relationship issues. Motivators included protection against HIV infection and the ability to safely engage in unprotected sex. Participants expressed reluctance to adopt partial efficacy vaccines and likelihood of increased sexual risk behaviors in response to vaccine availability., Conclusion: Tailored interventions to facilitate uptake of future U.S. Food and Drug Administration-approved HIV vaccines and to prevent risk behavior increases may be vital to the effectiveness of vaccines in controlling the AIDS pandemic.

Initial HIV vaccines are likely to be only partially efficacious; increased risk behaviors in response to future HIV vaccine availability have the potential to subvert the effectiveness of vaccines in controlling the AIDS epidemic. To assess attitudes, beliefs and behavioral intentions in response to hypothetical availability of FDA-approved HIV vaccines, we conducted 9 focus groups among participants (N = 99; median age = 33 years; 48% female; 22% African American, 44% Latino, 28% White) recruited from STD clinics, needle exchange programs, and Latino community based health organizations, using purposive, venue-based sampling, and interviewed 9 key informant service providers. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software. Participants predicted a "lightening up" of safer sex behaviors among at least half of their peers and, to a lesser extent, a relaxing of safer needle use practices in response to HIV vaccine availability. Both participants and providers urged HIV preventive interventions that: (1) provide education and awareness regarding partial efficacy vaccines, (2) combat the belief in an HIV vaccine as a "magic bullet," and (3) stressed the need for sustained behavioral risk reduction interventions in the face of continued HIV risk and other STDs.