Browsing by Author "Hosek, Sybil G."

Now showing 1 - 5 of 5
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    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 Nursing
    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.
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    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 Medicine
    BACKGROUND: 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.
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    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 Nursing
    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.
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    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 Nursing
    BACKGROUND: 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.
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    Transmission Risk among Youth Living with HIV in the United States
    (Elsevier, 2020-07) van den Berg, Jacob J.; Gamarel, Kristi E.; Westfall, Andrew O.; Fortenberry, J. Dennis; Hosek, Sybil G.; Wilson, Craig M.; Lally, Michelle A.; Medicine, School of Medicine
    Purpose: HIV treatment as prevention is effective for reducing the risk of HIV transmission and the messaging campaign, undetectable = untransmittable, is gaining recognition. As youth living with HIV (YLWH) who have condomless sex may acquire and potentially transmit other sexually transmitted infections (STIs), the purpose of this study was to assess potential differences in transmission risk of HIV and other STIs among YLWH to inform subsequent HIV and STI prevention efforts. Methods: A cohort of 600 HIV behaviorally infected youth aged 13-24 years who were engaged in medical care completed an audio computer-assisted self-interview including questions about demographics, HIV disclosure, mental health, substance use, and sexual behaviors and beliefs. HIV viral loads and the presence of other STIs were abstracted from medical records. A viral load <200 copies/mL was considered undetectable. Univariate and bivariate analyses were conducted to examine differences by viral load and STIs. Results: Participants were categorized into four groups: (1) undetectable without STIs (55.2%); (2) undetectable with STIs (14.2%); (3) detectable without STIs (22.8%); and (4) detectable with STIs (7.8%). In comparison to the other three groups, youth in the undetectable group with STIs reported more favorable sexual risk reduction attitudes and beliefs, internet use for finding sex partners, anal sex with male partners, and condomless anal sex with male partners. Conclusions: YLWH with undetectable viral loads and other STIs engaged in higher risk behaviors. To realize the promise of the messaging campaign, undetectable = untransmittable, efforts must focus on sustained viral suppression and prevention of STIs among YLWH.