353 research outputs found

    Extending and validating a human papillomavirus (HPV) knowledge measure in a national sample of Canadian parents of boys

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    As the human papillomavirus (HPV) vaccine is now recommended for males, a reliable, comprehensive HPV knowledge measurement tool which addresses issues relevant to males is needed. We aimed to replicate, validate and test the comprehensiveness of an existing general HPV and an HPV vaccination knowledge scale in English and French. We also measured parental HPV knowledge and changes over time. An online questionnaire was administered in February (Time 1; T1) and November 2014 (Time 2; T2) to a nationally representative sample of Canadian parents of boys. Dimensionality, internal consistency and model fit were evaluated at both time points and separately in English and French sub-samples. Differences in knowledge scores were measured. Analyses were performed on 3117 participants at T1 and 1427 at T2. The 25-item HPV general knowledge and an 11-item HPV vaccination scale were unidimensional, showed high internal consistency (α>0.87, α>0.73) and had good model fit. Both general HPV and vaccine-specific knowledge significantly increased over time in both languages, but remained low at T2, with only about half of the items being answered correctly. Correct responses at T2 are best explained by correct responses at T1, with some small changes from 'Don't know' at T1 to correct at T2. The extended general and vaccine-specific knowledge scales are valid, reliable and comprehensive, and could be used among parents of boys, in both English and French. Educational interventions could target specific knowledge gaps and focus on providing information rather than correcting misconceptions

    Adolescent Self-Consent for Biomedical HIV Prevention Research: Implications for Institutional Review Board Approval and Implementation

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    Purpose The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. Methods Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. Results A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. Conclusions The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations

    Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV

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    PURPOSE: There is a persistent HIV epidemic among sexual and gender minority adolescents in the U.S. Oral pre-exposure prophylaxis (PrEP) is an efficacious prevention strategy, but not yet approved for minors. Minors' access to biomedical HIV prevention technologies is impeded by the ethical and legal complexities of consent to research participation. We explore autonomous consent and study experiences among minor and adult participants in Project PrEPare, a Phase II safety study of PrEP for HIV prevention. METHODS: Data for this mixed-methods descriptive study were collected via self-administered web-survey and in-depth telephone interviews in early 2016. Eligible participants were previously enrolled in Project PrEPare. We attempted to contact 191 participants; 74 were reached and expressed interest in participating and 58 enrolled. RESULTS: Participants nearly universally felt well informed, understood the study, and freely volunteered with the clear understanding they could withdraw any time. All felt supported by study staff, but a small minority wished for more support during enrollment. Minors were more likely than adults to indicate a wish for more support in decision-making, and adults expressed higher satisfaction with their decision compared to minors. There was no association between elements of consent and Project PrEPare study outcomes. CONCLUSIONS: Participants had an overwhelmingly positive experience in a Phase II safety study of PrEP for HIV prevention. Some minors wished for more support during the decision-making process, but none consulted their parents about the decision. Our results support the inclusion of decisional supports in consent processes for adolescents, while also protecting their privacy

    Human Papilloma Virus vaccine and cervical cancer screening acceptability among adults in Quebec, Canada

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    <p>Abstract</p> <p>Background</p> <p>The Pap test has been used for cervical cancer screening for more than four decades. A human papillomavirus (HPV) vaccine has been approved for use in Canada and is commercially available now. These two preventive interventions should be considered simultaneously. General population support is an important factor for the successful combination of these interventions. The study had two objectives: 1) To assess practices, beliefs, and attitudes regarding Pap test screening and HPV immunization; 2) To identify socio-demographic factors for Pap screening and vaccine acceptability.</p> <p>Methods</p> <p>In 2006, 500 adults were invited to participate in a telephone survey in the region of Quebec City (urban and rural population, 600 000), Canada. Some neutral and standardized information on Pap test and HPV was provided before soliciting opinions.</p> <p>Results</p> <p>471 adults (18–69 year-olds) answered the questionnaire, the mean age was 45 years, 67% were female, and 65% had college or university degree. Eighty-six percent of women had undergone at least one Pap-test in their life, 55% in the last year, and 15% from 1 to 3 years ago. Among screened women, the test had been performed in the last three years in 100% of 18–30 year-olds, but only in 67% of 60–69 year-olds (P < 0.0001). Only 15% of respondents had heard of HPV. Eighty-seven percent agreed that HPV vaccines could prevent cervical cancer, 73% that the vaccine has to be administered before the onset of sexual activity, 89% would recommend vaccination to their daughters and nieces. Among respondents < 25 years, 91% would agree to receive the vaccine if it is publicly funded, but only 72% would agree to pay $100/dose.</p> <p>Conclusion</p> <p>There is an important heterogeneity in cervical cancer screening frequency and coverage. Despite low awareness of HPV infection, the majority of respondents would recommend or are ready to receive the HPV vaccine, but the cost could prevent its acceptability.</p

    Vaginal microbicide preferences among midwestern urban adolescent women

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    Abstract: Purpose The purpose of this study was to assess adolescent women&apos;s preferences for specific microbicide characteristics including pregnancy prevention, timing of application, potential for side effects, and whether it targeted human immunodeficiency virus (HIV) or other sexually transmitted infections (STI). Potential differences in microbicide preferences by adolescent age group and behavioral patterns including engaging in sexual intercourse and use of hormonal contraception were examined, as it was hypothesized that as adolescents progress into adulthood and gain sexual experience their preferences in microbicide characteristics may shift. Method Adolescent and young women (N = 405, 56.0% African American; 24.0% Euro-American) between the ages of 14 and 20 (mean = 17.0, SD = 1.8) were recruited from urban communitybased clinics. Video-Audio Computer-Assisted Self-Interviews were conducted with the young women, during which they were asked about their preferences regarding the characteristics of hypothetical vaginal microbicides. Conjoint analysis was utilized to determine adolescent women&apos;s relative preferences for each microbicide characteristic and intent-to-purchase microbicides based upon a combination of the selected properties. Results Overall, the results suggest adolescent and young women had an ordered preference for a microbicide with (1) no side effects, (2) pregnancy prevention, (3) postcoital application, and (4) protection against HIV. Age and behavioral group conjoint analyses resulted in the same pattern of preferences as those reported for the entire group. However, women having sex and not using hormonal contraception had a stronger preference for postcoital application. Conclusion The findings suggest that young women&apos;s ratings of microbicides were sensitive to characteristics such as side effects, pregnancy prevention, and timing of application and should be considered in microbicide development. The conjoint analysis approach is useful in understanding microbicide preferences, and should be utilized with other populations to assess preferences for specific microbicide characteristics. microbicides | adolescent women | sexuality | conjoint analysis | adolescent health | Keywords: sexual health Article: The search for a woman-initiated prevention method has led to focus on topical microbicides for sexually transmitted infection (STI)/ human immunodeficiency virus (HIV) prevention. Microbicides are substances that may substantially reduce transmission of STI when applied in the vagina or rectum [1]. Some microbicides may also prevent pregnancy, although not all microbicides will be contraceptive [2]. Microbicides are not currently commercially available; products are in various phases of clinical trials [1]. Most microbicides under development are coitus dependent, requiring women to recognize and prepare for sexual situations and be willing to use a product that requires some comfort with touching their genitals [3]. The process of inserting a microbicide into the vagina may be challenging, as the dialogue around young women&apos;s sexuality and their bodies is often lacking [4]. Acceptability research, therefore, remains crucial to anticipate and prospectively address the kinds of obstacles previously associated with other female-initiated products, such as the female condom [5] and [6]. For instance, although women enjoyed having more control in using the female condom, they often did not like the size and discomfort associated with use or the inability to use it covertly [6]. Extant microbicide acceptability research with young women has suggested that contraceptive and disease prevention properties, timing of use, and associated side effects are important characteristics [7]. The findings suggest that young women generally prefer both pregnancy and disease prevention in a single product and insertion with an applicator up to 8 hours in advance [8]. In addition, there is a preference for lubricating products [9] and [10] with low amounts of messiness [9] and leakage [8]. Previous research also indicated that relevant potential side effects may impact microbicide use, including yeast infections, vaginal itching, and allergic reactions [7] and [11]. Furthermore, access was an important gauge of acceptability in a group of adolescent women. Women indicated that microbicides should be promoted through &quot;adolescentspecific and girl-specific venues,&quot; including women&apos;s magazines [7]. There was also a reported desire for microbicides that would be small enough to carry in their pocket, bra, or within cell phone or palm pilot cases, and should be distributed through schools and sexuality education classes [7]. Most young women preferred over-the-counter availability of microbicides, yet stated they would be embarrassed if purchasing the product in the presence of others [7] and [8]. Thus far, microbicide acceptability research with adolescents has been conducted primarily with older adolescents, using individual interview and focus group methodologies [7] [16]. These qualitative methodologies allow for an in-depth assessment of individual as well as relational and age-related issues that may influence microbicide use [13] and [17]. However, social desirability is often a concern when studying stigmatized or socially sensitive issues associated with sexuality [18] and [19]. Past research has shown that using a video-audio computer-assisted self-interview (VACASI) format (participants privately responding to questions on a computer) for presenting survey questions alleviates the tendency for individuals to present themselves positively and answer questions in a socially desirable fashion [20]. In addition, women and adolescents report sensitive behaviors more frequently when questions are asked using computer interviewing techniques than when participating in a face-to-face interview [20], [21] and [22]. Existing microbicide acceptability research with adolescents also often lacks detailed attention to the multiple dimensions that must be considered simultaneously in a decision to try a product such as a microbicide. The addition of quantitative biopsychosocial studies addressing these issues thus complements the existing qualitative microbicide acceptability research [8], [23] and [24]. The purpose of this study was to quantitatively assess, using full-profile ratings based conjoint analysis, preferences for specific microbicide characteristics among a young, urban population of women. Building on the existing literature we chose to assess young women&apos;s preferences for pregnancy and STI (including HIV) prevention as well as timing of application and side effect potential. It was hypothesized that as women progress through the adolescent years, their relative preferences for specific microbicide characteristics may change as a function of their age and sexual experience. Methods Study participants Participants were 405 adolescent and young women between the ages of 14 and 20 (mean = 17, SD = 1.8) recruited from community-based urban health clinics in the Midwestern United States in an area with relatively low rates of HIV [25]. See Study procedure After informed consent was received, the young women were given a computer and headphones in a private exam room to begin the questionnaire. The VACASI began with participants being asked to choose one of four possible &quot;guides&quot; whose face and voice were used throughout the VACASI. Guides were young women (approximately 18-20 years old) who were professional actors of varied ethnic appearance and voice. The guides were used to increase young women&apos;s level of comfort with the interview [27]. Following the choice of a guide, more information was given about the microbicide and a product sample was shown. The participant was then asked multiple demographic and sexual behaviors questions and presented with microbicide vignettes that asked her to rate the likelihood of buying each microbicide. The self-interviews were completed in English and lasted 25-45 minutes. Participants received $20 compensation for the time and effort involved in completing the questionnaire. The protocols for the entire project were approved by the University&apos;s institutional review board

    Young women's use of a microbicide surrogate: The complex influence of relationship characteristics and perceived male partners' evaluations

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    This is the post-print version of the article. The official published version can be found at the link below.Currently in clinical trials, vaginal microbicides are proposed as a female-initiated method of sexually transmitted infection prevention. Much of microbicide acceptability research has been conducted outside of the United States and frequently without consideration of the social interaction between sex partners, ignoring the complex gender and power structures often inherent in young women’s (heterosexual) relationships. Accordingly, the purpose of this study was to build on existing microbicide research by exploring the role of male partners and relationship characteristics on young women’s use of a microbicide surrogate, an inert vaginal moisturizer (VM), in a large city in the United States. Individual semi-structured interviews were conducted with 40 young women (18–23 years old; 85% African American; 47.5% mothers) following use of the VM during coital events for a 4 week period. Overall, the results indicated that relationship dynamics and perceptions of male partners influenced VM evaluation. These two factors suggest that relationship context will need to be considered in the promotion of vaginal microbicides. The findings offer insights into how future acceptability and use of microbicides will be influenced by gendered power dynamics. The results also underscore the importance of incorporating men into microbicide promotion efforts while encouraging a dialogue that focuses attention on power inequities that can exist in heterosexual relationships. Detailed understanding of these issues is essential for successful microbicide acceptability, social marketing, education, and use.This study was funded by a grant from National Institutes of Health (NIHU19AI 31494) as well as research awards to the first author: Friends of the Kinsey Institute Research Grant Award, Indiana University’s School of HPER Graduate Student Grant-in-Aid of Research Award, William L. Yarber Sexual Health Fellowship, and the Indiana University Graduate and Professional Student Organization Research Grant

    Complex intervention to promote human papillomavirus (HPV) vaccine uptake in school settings: A cluster-randomized trial

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    Using a cluster-randomized trial design, we aimed to evaluate a complex intervention to increase uptake of human papillomavirus (HPV) vaccination in schools. The study was undertaken in high schools in Western Australia and South Australia between 2013 and 2015 with adolescents aged 12–13 years. Interventions included education, shared decision-making, and logistical strategies. The main outcome was school vaccine uptake. Secondary outcomes included consent forms returned and mean time to vaccinate 50 students. We hypothesised that a complex intervention would increase 3-dose HPV vaccine uptake. We recruited 40 schools (21 intervention, 19 control) with 6, 967 adolescents. There was no difference between intervention and control (3-dose mean 75.7% and 78.9%, respectively). Following adjustment for baseline covariates, absolute differences in coverage in favour of the intervention group were: dose 1, 0.8% (95% CI, − 1.4,3.0); dose 2, 0.2% (95% CI, − 2.7, 3.1); dose 3, 0.5% (95% CI, − 2.6, 3.7). The percentage of returned consent forms in intervention schools (91.4%) was higher than in control schools (difference: 6%, 95% CI, 1.4, 10.7). There was a shorter mean time to vaccinate 50 students at dose 3. The difference for dose 3 was 110 min (95% CI, 42, 177); for dose 2, 90 min (95% CI, − 15, 196); and dose 1, 28 min (95% CI, − 71, 127). Logs revealed the inconsistent implementation of logistical strategies. The intervention had no impact on uptake. Inadequate resourcing for logistical strategies and advisory board reluctance toward strategies with potential financial implications impacted the implementation of logistical components.Cristyn Davies, Helen S. Marshall, Julia M.L. Brotherton, Kirsten McCaffery, Melissa Kang, Kristine Macartney, Suzanne M. Garland, John Kaldorl, Gregory Zimet, S. Rachel Skinner, The HPV.edu Study Grou

    Acceptability of multipurpose human papillomavirus vaccines among providers and mothers of adolescent girls: A mixed-methods study in five countries

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    Introduction Multipurpose vaccines (MPVs) could be formulated to prevent multiple sexually transmitted infections simultaneously. Little is known about acceptability of MPVs among vaccine health care providers (HCPs) or mothers of adolescent girls. Methods 151 adolescent vaccine providers and 118 mothers of adolescent girls aged 9–14 were recruited from five geographically-diverse countries: Argentina, Malaysia, South Africa, South Korea, and Spain. We assessed providers’ preferences for single-purpose human papillomavirus (HPV) vaccine versus MPVs (including HPV+herpes simplex virus (HSV)−2, HPV+HIV, or HPV+HSV-2+HIV) via quantitative surveys. Maternal MPV attitudes were assessed in four focus group discussions (FGDs) in each country. Results Most providers preferred MPVs over single-purpose HPV vaccination, with preference ranging from 61% in Malaysia to 96% in South Africa. HPV+HSV-2+HIV was the most preferred MPV formulation (56–82%). Overall, 53% of the mothers preferred MPVs over single-purpose HPV vaccines, with strongest support in South Africa (90%) and lowest support in South Korea (29%). Convenience and trust in the health care system were commonly-cited reasons for MPV acceptability. Safety and efficacy concerns were common barriers to accepting MPVs, though specific concerns differed by country. Across FGDs, additional safety and efficacy information on MPVs were requested, particularly from trusted sources like HCPs. Conclusions Though maternal acceptability of MPVs varied by country, MPV acceptability would be enhanced by having HCPs provide parents with additional MPV vaccine safety and efficacy information. While most providers preferred MPVs, future health behavior research should identify acceptability barriers, and targeted provider interventions should equip providers to improve vaccination discussions with parents
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