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Browsing by Author "Kapogiannis, Bill G."
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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 Evaluating Testing Strategies for Identifying Youths With HIV Infection and Linking Youths to Biomedical and Other Prevention Services(American Medical Association, 2017-06-01) Miller, Robin Lin; Boyer, Cherrie B.; Chiaramonte, Danielle; Lindeman, Peter; Chutuape, Kate; Cooper-Walker, Bendu; Kapogiannis, Bill G.; Wilson, Craig M.; Fortenberry, J. Dennis; Pediatrics, School of MedicineImportance: Most human immunodeficiency virus (HIV)-infected youths are unaware of their serostatus (approximately 60%) and therefore not linked to HIV medical or prevention services. The need to identify promising and scalable approaches to promote uptake of HIV testing among youths at risk is critical. Objective: To evaluate a multisite HIV testing program designed to encourage localized HIV testing programs focused on self-identified sexual minority males and to link youths to appropriate prevention services after receipt of their test results. Design, Setting, and Participants: Testing strategies were evaluated using an observational design during a 9-month period (June 1, 2015, through February 28, 2016). Testing strategies were implemented by 12 adolescent medicine HIV primary care programs and included targeted testing, universal testing, or a combination. Data were collected from local youth at high risk of HIV infection and, specifically, sexual minority males of color. Main Outcomes and Measures: Proportion of sexual minority males and sexual minority males of color tested, proportion of previously undiagnosed HIV-positive youths identified, and rates of linkage to prevention services. Results: A total of 3301 youths underwent HIV testing. Overall, 35 (3.6%) of those who underwent universal testing in primary care clinical settings, such as emergency departments and community health centers, were sexual minority males (35 [3.6%] were males of color) compared with 236 (46.7%) (201 [39.8%] were males of color) who were tested through targeted testing and 693 (37.8%) (503 [27.4%] were males of color) through combination efforts. Identification of new HIV-positive cases varied by strategy: 1 (0.1%) via universal testing, 39 (2.1%) through combination testing, and 16 (3.2%) through targeted testing. However, when targeted tests were separated from universal testing results for sites using a combined strategy, the rate of newly identified HIV-positive cases identified through universal testing decreased to 1 (0.1%). Rates of new HIV-positive cases identified through targeted testing increased to 49 (6.3%). Youths who tested through targeted testing (416 [85.1%]) were more likely to link successfully to local HIV prevention services, including preexposure prophylaxis, compared with those who underwent universal testing (328 [34.1%]). Conclusions and Relevance: The findings suggest that community-based targeted approaches to HIV testing are more effective than universal screening for reaching young sexual minority males (especially males of color), identifying previously undiagnosed HIV-positive youths, and linking HIV-negative youths to relevant prevention services. Targeted, community-based HIV testing strategies hold promise as a scalable and effective means to identify high-risk youths who are unaware of their HIV status.Item HIV Continuum of Care for Youth in the United States(Wolters Kluwer, 2018-01-01) Lally, Michelle A.; van den Berg, Jacob J.; Westfall, Andrew O.; Rudy, Bret J.; Hosek, Sybil G.; Fortenberry, J. Dennis; Monte, Dina; Tanney, Mary R.; McFarland, Elizabeth J.; Xu, Jiahong; Kapogiannis, Bill G.; Wilson, Craig M.; Pediatrics, School of MedicineBACKGROUND: Beneficial HIV treatment outcomes require success at multiple steps along the HIV Continuum of Care. Youth living with HIV are a key population, and sites in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) are known for modeling optimum HIV adolescent care. METHODS: A longitudinal cohort study conducted at 14 network sites across the United States assessed how the later steps of the Continuum of Care were achieved among the youth: engagement, treatment, and viral load (VL) suppression. Youth aged 13-24 who were behaviorally infected with HIV and linked to care at an ATN-affiliated site were eligible to participate. RESULTS: A total of 467 youth were enrolled and had 1 year of available data. Most were aged 22-24 (57%), male (79%), and black/non-Hispanic (71%). Most used alcohol (81%) and marijuana (61%) in the 3 months before enrollment, and 40% had a history of incarceration. Among this cohort of youth, 86% met criteria for care engagement; among these, 98% were prescribed antiretroviral therapy and 89% achieved VL suppression. Sustained VL suppression at all measured time points was found among 59% with initial suppression. Site characteristics were notable for the prevalence of adherence counseling (100%), case management (100%), clinic-based mental health (93%), and substance use (64%) treatment. CONCLUSIONS: Youth living with HIV in the United States can be successfully treated at health care sites with experience, excellence, and important resources and services. Sustained VL suppression may be an important step to add to the Continuum of Care for youth.Item Implementation of an Integrated Approach to the National HIV/AIDS Strategy for Improving Human Immunodeficiency Virus Care for Youths(AMA, 2017-07) Fortenberry, J. Dennis; Koenig, Linda J.; Kapogiannis, Bill G.; Ellen, Jonathan M.; Wilson, Craig M.; Pediatrics, School of MedicineImportance Youths aged 13 to 24 years old living with human immunodeficiency virus (HIV) are less likely than adults to receive the health and prevention benefits of HIV treatments, with only a small proportion having achieved sustained viral suppression. These age-related disparities in HIV continuum of care are owing in part to the unique developmental issues of adolescents and young adults as well as the complexity and fragmentation of HIV care and related services. This article summarizes a national, multiagency, and multilevel approach to HIV care for newly diagnosed youths designed to bridge some of these fragmentations by addressing National HIV/AIDS Strategy goals for people living with HIV. Design, Setting, and Participants Three federal agencies developed memoranda of understanding to sequentially implement 3 protocols addressing key National HIV/AIDS Strategy goals. The goals were addressed in the Adolescent Trials Network, with protocols implemented in 12 to 15 sites across the United States. Outcome data were collected from recently diagnosed youth referred to the program. Main Outcomes and Measures Cross-agency collaboration, youth-friendly linkage to care services, community mobilization to address structural barriers to care, cooperation among services, proportion of all men who have sex with men who tested, and rates of linkage to prevention services. Results The program addressed National HIV/AIDS Strategy goals 2 through 4 including steps within each goal. A total of 3986 HIV-positive youths were referred for care, with more than 75% linked to care within 6 weeks of referral, with almost 90% of those youths engaged in subsequent HIV care. Community mobilization efforts implemented and completed structural change objectives to address local barriers to care. Age and racial/ethnic group disparities were addressed through targeted training for culturally competent, youth-friendly care, and intensive motivational interviewing training. Conclusions and Relevance A national program to address the National HIV/AIDS Strategy specifically for youths can improve coordination of federal resources as well as implement best-practice models that are adapted to decrease service fragmentation and systemic barriers at local jurisdictions.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.