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Browsing by Author "Knopf, Amelia S."
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Item Adolescent Self-Consent for Biomedical HIV Prevention Research: Implications for Institutional Review Board Approval and Implementation(Elsevier, 2015-07) Gilbert, Amy Lewis; Knopf, Amelia S.; Fortenberry, J. Dennis; Hosek, Sybil G.; Kapogiannis, Bill G.; Zimet, Gregory D.; IU School of NursingPurpose 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.Item Avoiding a Tyranny of the Majority: Public Deliberation as Citizen Science, Sensitive Issues, and Vulnerable Populations(Taylor & Francis, 2019) Ott, Mary A.; Knopf, Amelia S.; Pediatrics, School of MedicineItem By Default: How Mothers in Different-Sex Dual-Earner Couples Account for Inequalities in Pandemic Parenting(Sage, 2021) McCrory Calarco, Jessica; Meanwell, Emily; Anderson, Elizabeth M.; Knopf, Amelia S.; School of NursingMothers did a disproportionate share of the child care during the COVID-19 pandemic—an arrangement that negatively impacted their careers, relationships, and well-being. How did mothers account for these unequal roles? Through interviews and surveys with 55 mothers (and 14 fathers) in different-sex, prepandemic dual-earner couples, we found that mothers (and fathers) justified unequal parenting arrangements based on gendered structural and cultural conditions that made mothers’ disproportionate labor seem “practical” and “natural.” These justifications allowed couples to rely on mothers by default rather than through active negotiation. As a result, many mothers did not feel entitled to seek support with child care from fathers or nonparental caregivers and experienced guilt if they did so. These findings help explain why many mothers have not reentered the workforce, why fathers’ involvement at home waned as the pandemic progressed, and why the pandemic led to growing preferences for inegalitarian divisions of domestic and paid labor.Item Case 27-2021: A 16-Year-Old Boy Seeking Human Immunodeficiency Virus Prophylaxis(NEJM Group, 2021-09) Neilan, Anne M.; Salvant Valentine, Sheila; Knopf, Amelia S.; School of NursingItem Ethical Approaches to Vaccine Allocation and Administration in Carceral Settings, With a Focus on Youth(Mary Ann Liebert, Inc., 2022-10) Enujioke, Sharon C.; Knopf, Amelia S.; Aalsma, Matthew C.; School of NursingCOVID-19 has disproportionately impacted Americans in carceral settings and secure facilities. A disproportionate number of persons who are confined to carceral settings and secure facilities are members of racial, ethnic, and socioeconomic groups who experience a significant burden of COVID-19 morbidity and mortality. The pandemic-related disparities experienced by minoritized and detained adult populations have received national attention, but the burden of COVID-19 risk among justice-involved youth has been largely absent from these national conversations. With more than 40,000 youth in carceral settings, their COVID-19 risks and prevention needs warrant specific consideration, especially as vaccine distribution programs expand. Youth have been assigned a lower priority status in most state vaccine allocation plans, but youth in carceral settings are at increased risk compared with their peers, raising important questions about how to ethically allocate and administer vaccines to them. In this article we examine ethical issues that arise in the health care of minors in carceral settings and identify an ethical model that could be used to reconsider the allocation of COVID-19 vaccines.Item Measuring research mistrust in adolescents and adults: Validity and reliability of an adapted version of the Group-Based Medical Mistrust Scale(PLOS, 2021-01-22) Knopf, Amelia S.; Krombach, Peter; Katz, Amy J.; Baker, Rebecca; Zimet, Gregory; School of NursingMistrust of health care providers among persons of color is a significant barrier to engaging them in research studies. Underrepresentation of persons of color is particularly problematic when the health problem under study disproportionately affects minoritized communities. The purpose of this study was to test the validity and reliability of an abbreviated and adapted version of the Group Based Medical Mistrust Scale. The GBMMS is a 12-item scale with three subscales that assess suspicion, experiences of discrimination, and lack of support in the health care setting. To adapt for use in the research setting, we shortened the scale to six items, and replaced "health care workers" and "health care" with "medical researchers" and "medical research," respectively. Using panelists from a market research firm, we recruited and enrolled a racially and ethnically diverse sample of American adults (N = 365) and adolescents aged 14-17 (N = 250). We administered the adapted scale in a web-based survey. We used Cronbach's alpha to evaluate measure internal reliability of the scale and external factor analysis to evaluate the relationships between the revised scale items. Five of the six items loaded onto a single factor, with (α = 0.917) for adolescents and (α = 0.912) for adults. Mean scores for each item ranged from 2.5-2.9, and the mean summary score (range 6-25) was 13.3 for adults and 13.1 for adolescents. Among adults, Black respondents had significantly higher mean summary scores compared to whites and those in other racia/ethnic groups (p<0.001). There was a trend toward significance for Black adolescents as compared to white respondents and those in other racial/ethnic groups (p = 0.09). This five-item modified version of the GBMMS is reliable and valid for measuring research mistrust with American adults and adolescents of diverse racial and ethnic identities.Item Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV(Elsevier, 2017-12) Knopf, Amelia S.; Ott, Mary A.; Liu, Nancy; Kapogiannis, Bill G.; Zimet, Gregory D.; Fortenberry, J. Dennis; Hosek, Sybil G.; School of NursingPURPOSE: 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.Item Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents(Taylor & Francis, 2017-07) Knopf, Amelia S.; Gilbert, Amy Lewis; Zimet, Gregory D.; Kapogiannis, Bill G.; Hosek, Sybil G.; Fortenberry, J. Dennis; Ott, Mary A.; The Adolescent Medicine Trials Network for HIV/AIDS Interventions; School of NursingBACKGROUND: Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. METHODS: We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. RESULTS: Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties-protective and scientific-previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. CONCLUSIONS: Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.Item Sexual learning among East African adolescents in the context of generalized HIV epidemics: A systematic qualitative meta-synthesis(PLOS, 2017-03-09) Knopf, Amelia S.; McNealy, Kim R.; Al-Khattab, Halima; Carter-Harris, Lisa; Oruche, Ukamaka M.; Naanyu, Violet; Burke Draucker, Claire; IU School of NursingBackground AIDS-related illness is the leading cause of mortality for adolescents in sub-Saharan Africa. Together, Kenya, Tanzania, and Uganda account for 21% of HIV-infected adolescents in sub-Saharan Africa. The United Nations framework for addressing the epidemic among adolescents calls for comprehensive sexual and reproductive health education. These HIV prevention efforts could be informed by a synthesis of existing research about the formal and informal sexual education of adolescents in countries experiencing generalized epidemics. The purpose of this study was to describe the process of sexual learning among East African adolescents living in the context of generalized HIV epidemics. Methods Qualitative metasynthesis, a systematic procedure for integrating the results of multiple qualitative studies addressing a similar phenomenon, was used. Thirty-two research reports met study inclusion criteria. The reports were assessed in a four-step analytic process: appraisal, classification of findings, synthesis of findings, and construction of a framework depicting the process of sexual learning in this population. Results The framework includes three phases of sexual learning: 1) being primed for sex, 2) making sense of sex, and 3) having sexual experiences. Adolescents were primed for sex through gender norms, cultural practices, and economic structures as well as through conversations and formal instruction. They made sense of sex by acquiring information about sexual intercourse, reproduction and pregnancy, sexually transmitted infections, and relationships and by developing a variety of beliefs and attitudes about these topics. Some adolescents described having sexual experiences that met wants or needs, but many experienced sex that was coerced or violent. Whether sex was wanted, coerced, or violent, adolescents experienced worry about sexually transmitted infections or premarital pregnancy. Conclusions The three phases of sexual learning interact to shape adolescents’ sexual lives and their risk for HIV infection. This framework will contribute to the development of sexual education programs that address HIV risk within the broader context of sexual learning.Item Synthesizing Adaptive Digital Bioethics to Guide the Use of Interactive Communication Technologies in Adolescent Behavioral Medicine: A Systematic Configurative Review(Elsevier, 2022-08-01) Skeen, Simone J.; Shaw Green, Sara K.; Knopf, Amelia S.; School of NursingDespite the continuing integration of digital outreach tools into adolescent preventive services, adaptive guidance for their ethical use remains limited. In this configurative review, we synthesize the ad hoc, applied digital bioethics developed in adolescent human immunodeficiency virus prevention science. By focusing on generalizable technological affordances, while balancing privacy and autonomy, we offer strategies for identifying potential technologically mediated harms that can transcend specific platforms, tools, or the knowledge levels of individual clinicians. Clinical vignettes illustrate the application of these strategies.