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Objective: Genital warts and human papillomavirus (HPV)-associated cancers in men can be substantially reduced through HPV vaccination; yet, globally, HPV vaccine uptake among boys remains low. This meta-ethnography synthesizes qualitative studies to understand, in-depth, HPV vaccine acceptability and decision-making among adolescent boys and/or their parents., Methods: A systematic search identified qualitative studies examining HPV vaccines from the perspectives of boys and/or boys' parents. The Consolidated Criteria for Reporting Qualitative Research (COREQ) 32-item checklist was used to assess quality of reporting. Using meta-ethnographic techniques, we conducted a structured and iterative process of data analysis, coded original studies, and then developed descriptive and analytic themes to synthesize the findings., Results: Review of 15 eligible studies (n = 3362 parents, n = 39 boys) revealed multilevel factors that influence HPV vaccine acceptability and decision-making among adolescent boys and their parents: (1) individual, e.g., low HPV vaccine knowledge/awareness, (2) interpersonal, e.g., key relationships between parents, sons, and healthcare providers (HCP), (3) community/societal, e.g., parental duty to protect, and (4) systemic, e.g., HPV vaccine messaging. Parents generally accepted adolescent boys' sexuality and the need for vaccination, motivated by wanting to protect their sons from HPV and HPV-associated cancers, and valued HCP-initiated discussion and recommendation. Acceptability was mitigated by low awareness/knowledge of HPV vaccines and low perceived benefits for boys, lack of HCP-initiated discussion, out-of-pocket costs, multiple doses, stigma, and mixed messages about HPV., Conclusions: Multilevel factors influence HPV vaccine acceptability and decision-making among parents and their adolescent sons. Providing clear and unambiguous messages about HPV vaccines-for whom (boys and girls), for what (genital warts and cancers in men), and when (before sexual debut)-through increased HCP-initiated discussion and targeted public health campaigns may support HPV vaccine uptake among boys. Future research should consistently disaggregate findings by sex of child and parent, and explore effective messaging tailored for boys and parents., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

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.)

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.)

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.)

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.

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.

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.

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.

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.