DOCSLIB.ORG

Copyright and Use of This Thesis This Thesis Must Be Used in Accordance with the Provisions of the Copyright Act 1968

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Copyright and Use of This Thesis This Thesis Must Be Used in Accordance with the Provisions of the Copyright Act 1968 COPYRIGHT AND USE OF THIS THESIS This thesis must be used in accordance with the provisions of the Copyright Act 1968. Reproduction of material protected by copyright may be an infringement of copyright and copyright owners may be entitled to take legal action against persons who infringe their copyright. Section 51 (2) of the Copyright Act permits an authorized officer of a university library or archives to provide a copy (by communication or otherwise) of an unpublished thesis kept in the library or archives, to a person who satisfies the authorized officer that he or she requires the reproduction for the purposes of research or study. The Copyright Act grants the creator of a work a number of moral rights, specifically the right of attribution, the right against false attribution and the right of integrity. You may infringe the author’s moral rights if you: - fail to acknowledge the author of this thesis if you quote sections from the work - attribute this thesis to another author - subject this thesis to derogatory treatment which may prejudice the author’s reputation For further information contact the University’s Director of Copyright Services sydney.edu.au/copyright Good, better or best: A study of standards of prevention and care in HIV prevention trials Bridget Haire A thesis submitted in fulfilment of the requirements for the degree of DOCTOR OF PHILOSOPHY at the University of Sydney, Sydney, New South Wales, Australia. 2013 Supervisor’s Certification I, Dr Christopher Jordens, certify that the PhD thesis entitled ‘Good, better or best: A study of standards of prevention and care in HIV prevention trials’ by Bridget Haire is in a suitable form for examination. ……………………. Christopher Jordens ……………………. Date ii Candidate’s Declaration I, Bridget Haire, hereby declare that the work described in this thesis is my own. I am the principal researcher of all work contained in this thesis, including work conducted in association with my PhD supervisors and other co-authors. This thesis does not contain written or published materials prepared by others except where acknowledged within the text and has not been submitted to any other university or institution as a part or whole requirement for any higher degree. I, Bridget Haire, understand that if I am awarded a higher degree for my thesis entitled ‘Good, better or best: Standards of prevention and care in HIV prevention research’, being lodged for examination, the thesis will be lodged in the University Library and be available immediately for use. I agree that the University Librarian (or in the case of a department, the Head of Department) may supply a photocopy or microform of the thesis to an individual for research or study or to a library. ……………………. Bridget Haire Date: 27/03/2013 iii Abstract Introduction This is a study of the negotiation of benefits in HIV biomedical prevention trials. It took place at a very dynamic period in HIV prevention research, 2009-2012, during which there were positive efficacy results from six large, randomised controlled trials of HIV prevention interventions. This study presents evidence on how benefits to participants are negotiated in efficacy trials of biomedical HIV prevention technologies. It re-considers debates about obligations to trial participants in the light of the positive trial results and asks how partially effective HIV prevention modalities impact on these debates. Methods Empirical The empirical components of the study comprise: • a survey of principal investigators who conducted HIV prevention trials • 14 in-depth interviews with principal investigators; and • additional data collection from document analysis and personal communications. Descriptive statistics were calculated for survey responses, and interview data were analysed thematically from a symbolic interactionist perspective. iv Normative The normative component focuses on four big-picture issues: Whether there is ethical justification for antiretroviral (ARV)-based prevention in HIV endemic areas; How the positive HIV prevention trial results – which demonstrate partial efficacy – affect (or should affect) future HIV prevention research; The implications of incorporating newly validated technologies into the standard of prevention; and Whether PrEP should become the comparator arm in HIV prevention trials from now on. Results Procedural norms have developed regarding some aspects of standard of prevention. There are differences however regarding whether standards of prevention should be basic or optimal, and whether or when new interventions should be added. Access to ARV for seroconverters, usually through partnerships, has also become a norm, and some principal investigators also reported a strong obligation towards those ‘screened out’ of trials – volunteers with pre-existing HIV infection. The importance of various forms of ancillary care provision was recognised and negotiation of this care helped establish the research project as part of a healthcare continuum. Post-trial access provisions were in place for all the interventions that had successful efficacy results. There were significant differences in both the duration and the timeliness of actual post-trial provision, however. v Conclusion Partially effective interventions pose problems for enduring post-trial access as by definition, they raise questions about ‘how good is good enough’ for implementation within particular epidemic settings. A similar dilemma is faced with regard to standard of prevention. The key question facing HIV prevention research is how to test new experimental interventions in the context of partially effective interventions. Ongoing research into new intervention is crucial, but reducing HIV incidence in trial populations is a legitimate goal. Hence, it is time to include a proven biologically effective intervention as an active comparator in HIV prevention trials. The goals of HIV prevention research must be to find the most effective ways of using existing tools and to establish the effectiveness of new tools. An active comparator balances the need to protect participants with the need to develop new interventions. vi For Marion and Lucy, whose manifold perfections inspire me ever to strive. vii Acknowledgements Thank you to all the participants who donated their time to this research. Without you, this thesis could not have happened. The completion of this research and thesis owes much to the generous support of many others too. I would like to thank my primary supervisor, Dr Chris Jordens, who has been a great champion of this project from its inception – by turns an enthusiastic supporter or stern critic as required. Thank you for all your work, and for your faith. My associate supervisors have also provided invaluable advice and support. A/Professor Ian Kerridge gave thoughtful feedback on many of the articles published herein and, as importantly, has made the Centre for Values, Ethics and the Law in Medicine (VELiM) a rich and harmonious environment for working and learning. Thanks too to A/Professor Bebe Loff for her advice on the survey questions, ethics submission and for posing challenging questions. Professor John Kaldor had no formal supervisory role in this research, but his gregarious collegiality led to him playing a significant role in many aspects. John persuaded several elusive principal investigators to talk to me. He also (rightly) insisted on my principal investigator survey being redesigned, provided a sounding board for many of the key ideas in this thesis, and acted as a co-author on two articles. I am immensely grateful for his input. I thank the students and staff at VELiM who have provided great camaraderie and taught me innumerable lessons. Particular thanks is due to Aric, Bronwyn, Camilla, viii Chris, David, Denise, Estelle, Henry, Jacqueline, Jane, Jenn, Julie, Lindy, Lucie, Peter, Pippa, Rowena, Sascha, Scott, Stacy, Vincy, Wendy and Emeritus Professor Miles Little. Dr Jeanne Ellard and Dean Murphy have enabled me to work by looking after my daughter, and also enriched my frames of reference through invigorating conversations and the sharing of papers and research plans. It has been great to have family around who speak AIDS. I also thank Chris Murphy for taking care of my family so well for all those weekends. Finally, thank you to Marion and Lucy and your patience and understanding, your cheerful reading of drafts, incisive commentary, and enthusiastic use of tracked changes. Next week it will be proper meals and folded laundry all the way. ix List of publications and presentations Peer reviewed articles included in this thesis Haire B., and C. Jordens. 2013. Standard of prevention in the real world: A qualitative study of principal investigators in HIV biomedical prevention trials. AJOB Primary Research. Accepted Feb 26, 2013 Haire B., and J. Kaldor. 2013. Ethics of ARV-based prevention: PrEP and treatment- as-prevention. Developing World Bioethics. Accepted Jan 10, 2013. Haire, B., M. Folayan, C. Hankins, J. Sugarman, S. McCormack, G. Ramjee and M. Warren. 2013. Ethical considerations in determining standard of prevention packages for HIV prevention trials: Examining PrEP. Developing World Bioethics. Accepted Jan 10, 2013. Haire, B. 2013. Ethics of medical care and clinical research. Journal of Medical Ethics. 2013;39:231-235. Published Online First: 22 November 2012 doi:10.1136/medethics-2012-100936 Haire, B. J. Kaldor, C.F.C. Jordens. 2012. How good is ‘good enough’: When should new HIV technologies should become standard of care? American Journal of Bioethics 2012, 12(6):21-30. x Haire, B. 2011. Because we can: Clashes of perspective over obligation in the failed PrEP trials. Developing World Bioethics, 11 (2):63-74.| DOI: 10.1111/j.1471- 8847.2010.00292.x Relevant peer-reviewed articles not included in this thesis (available in Appendix C) McGregor, S., G. Tachedjian, B.G. Haire, J.M. Kaldor. 2013.The Seventh and last international microbicides conference: From discovery to delivery. Sexual Health. Accepted January 16, 2013. Haire, B. 2011.Treatment-as-prevention needs to be considered in the just allocation of HIV drugs. American Journal of Bioethics 11(12):48-50 Haire, B.
Load more

Recommended publications
  • Communications Handbook for Clinical Trials
    Communications Handbook for Clinical Trials Strategies, tips, and tools to manage controversy, convey your message, and disseminate results By Elizabeth T. Robinson Deborah Baron Lori L. Heise Jill Moffett Sarah V. Harlan Preface by Archbishop Desmond M. Tutu Communications Handbook for Clinical Trials Strategies, tips, and tools to manage controversy, convey your message, and disseminate results By Elizabeth T. Robinson Deborah Baron Lori L. Heise Jill Moffett Sarah V. Harlan Preface by Archbishop Desmond M. Tutu Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your Message, and Disseminate Results Authors: Elizabeth T. Robinson, Deborah Baron, Lori L. Heise, Jill Moffett, Sarah V. Harlan © FHI 360 ISBN: 1-933702-57-5 The handbook is co-published by the Microbicides Media and Communications Initiative, a multi-partner collaboration housed at the Global Campaign for Microbicides at PATH in Washington, DC, and by Family Health International in Research Triangle Park, NC, USA. In July 2011, FHI became FHI 360. The Microbicides Media and Communica- tions Initiative is now housed at AVAC. AVAC: Global Advocacy for HIV Prevention 423 West 127th Street, 4th Floor New York, NY 10027 USA Tel: +1.212.796.6243 Email: [email protected] Web: www.avac.org FHI 360 P.O. Box 13950 Research Triangle Park, NC 27709 USA Tel: +1.919.544.7040 E-mail: [email protected] Web: www.fhi360.org This work was made possible by the generous support of the American people through the U.S. Agency for International Development (USAID) through dual grants to the Microbicides Media and Communications Initiative (MMCI), a project of the Global Campaign for Microbicides at PATH, and to FHI 360.
    [Show full text]
  • Drugs, Data, Deliberations
    JANUARY 2016 Issue 5 [email protected] www.facebook.com/linkagesproject @LINKAGESproject DRUGS, DATA, DELIBERATIONS: PUTTING IT INTO PERSPECTIVE People who inject drugs continue to be disproportionately affected by HIV because of limited investment in — and access to — proven interventions. Even when effective services are available, severe stigma and punitive laws create barriers to their use, compounding people’s risk of acquiring HIV and hepatitis infection through unsterile injection equipment. Discrimination against drug users and criminalization of drug use also make it difficult to collect accurate data about people who inject drugs. Estimates of HIV prevalence among people who inject drugs; the size of drug-using populations; and their use of HIV prevention, care, and treatment services are incomplete, as is understanding of their needs and risk behaviors, because many people are unwilling to identify themselves as users of illicit drugs. All over the world, successful responses Photo Credit: © Malaysian AIDS Council / International HIV/AIDS Alliance to the HIV epidemic have been driven in large part by two key factors: Personal experiences inspired Amran Ismail to establish the first community- political commitment and agency of the based organization in Kuala on the east coast of Malaysia, CAKNA, which constituency group. For people who supports people who inject drugs. inject drugs, neither of these pillars has been given sufficient attention The Link, our guest authors write about of people who inject drugs are often and dedicated focus. In this issue of innovative efforts to strengthen both. gender-neutral or heavily skewed toward the men. Although women who IN THIS ISSUE On page 4, Judy Chang writes about inject drugs are even more hidden than Afghani women who use drugs—a 1 | DRUGS, DATA, DELIBERATIONS their male counterparts, they account 3 | HISTORIES OF COMMUNITY ACTION group who, traditionally, has had about for about one-third of all people who 4 | OUT OF THE SHADOWS as little agency as it’s possible to have.
    [Show full text]
  • Fhi-360-Impact-Report-2019.Pdf
    2019 Contents Impact Stories � � � � � � � � � � � � � � � � � � � � � � � � � � � � 2 Financial Summary � � � � � � � � � � � � � � � � � � � � � � � 14 Funders � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 17 Global Reach � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 19 Contact Us � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 20 FHI 360 2019 IMPACT REPORT 1 CRISIS RESPONSE Responding in real time to Ebola PROJECT Rapid response and building trust with DRC Ebola Rapid Response communities are critical when stopping the spread of infectious disease� During the 2018 FUNDER Ebola outbreak in the Democratic Republic of U�S� Agency for the Congo, we worked with hundreds of International Development, Office of U�S� Foreign community leaders who mobilized their Disaster Assistance communities in prevention, surveillance and control of the disease� Local teams were trained to conduct safe and dignified burials for Ebola victims with the consent of families and communities and responded to 672 community death alerts in North Kivu and Ituri provinces� Our Ebola community engagement activities reached more than 9,000 people, including 679 community leaders in provinces most 9,000+ affected by the outbreak� people reached through community engagement activities in the Democratic Republic of the Congo FHI 360 2019 IMPACT REPORT 2 EDUCATION Building community among Native American tribes PROJECT Across the United States, less than 2 percent Head Start of the 46,000 Native American and Alaskan Native children
    [Show full text]
  • Vitalconnections
    2012 annuAL REPORT vitalconnections www.fhi360.org LETTER FROM THE CEO Adolescent girls in Kenya are paired with In FHI 360’s 2012 annual report, you will older mentors who encourage them to read about just a few of the connections that further their education. distinguish our unique ability to bring a 360° perspective to some of the world’s most Mothers in Vietnam are supported to give complex human development challenges. infants the best start in life through landmark And you will see how we translate this legislation and promotion of breastfeeding perspective into customized solutions that best practices. are making a real difference in people’s lives around the world. Researchers from around the world bring “Making the right together experience and skills to develop Ensuring our work is relevant and leads to the next generation of family planning sustainable results guides our every step. technologies. Informed by sound evidence and decades of connections can collaborative in-country experience, we design Making the right connections can our programs and initiatives to strengthen the transform lives. capacity of communities and nations to solve transform lives.” problems and drive progress for years to come. This past year, we connected as never before. Our reach was global; our impact, lasting. Ours is a journey of collaboration where our Our experts in health, education, nutrition, funders and partners are at the heart of all environment, economic development, we do. Through these most vital connections civil society, gender equality, youth, we can see farther, dream bigger and achieve research, technology, communication and far more than we ever could alone.
    [Show full text]
  • Biobehavioural Survey Guidelines for Populations at Risk for HIV © World Health Organization 2017
    Global HIV Strategic Information Working Group Biobehavioural Survey Guidelines For Populations At Risk For HIV © World Health Organization 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). The mark “CDC” is owned by the US Dept. of Health and Human Services and is used with permission. Use of this logo is not an endorsement by HHS or CDC of any particular product, service, or enterprise. Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation WHO, CDC, UNAIDS, FHI 360. Biobehavioral survey guidelines for Populations at Risk for HIV.
    [Show full text]
  • Programme INTEREST 2020
    PROGRAMME BOOK www.interestconference.org Table of Contents Welcome 3 Objectives 4 Practical Information 5 Time Zones 6 Committees 8 Programme 13 Acknowledgement 24 2 INTEREST 2020 - Programme Book Welcome Dear Colleagues, Welcome to the 14th INTEREST Conference November 30-December 4, 2020 and the conference pre-week November 23-27! Since 2014, we have dedicated the annual INTEREST Conference to the memory of Professor Joep Lange and Jacqueline van Tongeren of the Amsterdam Institute for Global Health and Development. Pivotal in establishing the INTEREST conference as a leading African and international forum for the dissemination of HIV science and practice, they died tragically when Malaysian Airlines flight MH17 was shot down over Ukraine on July 17, 2014. The INTEREST Conference is now a recognised fixture in the HIV conference calendar. It focuses on HIV treatment, pathogenesis, and prevention in resource-limited settings, particularly in Africa. Young researchers and established international HIV experts share original research and state-of-the-art reviews on a wide range of HIV and related topics. In light of the SARS-CoV-2 pandemic, the 14th INTEREST conference was initially postponed from the face-to-face conference that had been planned for Windhoek, Namibia in May to the first week of December. A decision was made in late August 2020 to move to a virtual format, which has proven to be a wise move, given that the pandemic is continuing to expand as INTEREST pre-week activities are about to start. The 14th INTEREST conference offers lectures, abstract-driven oral and poster sessions, and symposia but this year there will be no debates or meet-the-expert lunches.
    [Show full text]
  • Strategic Considerations for Strengthening the Linkages Between Family Planning and HIV/AIDS Policies, Programs, and Services
    Family Planning HIV/AIDS Strategic Considerations for Strengthening the Linkages between Family Planning and HIV/AIDS Policies, Programs, and Services In July 2011, FHI became FHI 360. FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research and technology – creating a unique mix of capabilities to address today’s interrelated development challenges. FHI 360 serves more than 60 countries, all 50 U.S. states and all U.S. territories. Visit us at www.fhi360.org. Family Planning HIV/AIDS Strategic Considerations for Strengthening the Linkages between Family Planning and HIV/AIDS Policies, Programs, and Services Strategic Considerations for Strengthening the Linkages between Family Planning and HIV/AIDS Policies, Programs, and Services © 2009 by World Health Organization All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications—whether for sale or for noncommercial distribution—should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.
    [Show full text]
  • Health System Rapid Diagnostic Tool
    VersION 1 Health System Rapid Diagnostic Tool FRAMEWORK, OPERATIONAL GUIDE, AND METRICS TO MEASURE THE STRENGTH OF PRIORITY HEALTH SYSTEM FUNCTIONS By David Wendt With contributions from Bruno Bouchet, Ya-Shin Lin, Lipika Nanda, Shanthi Noriega, Nilufar Rakhmanova, and Sarah Searle PREPARING FOR THE RAPID DIAGNOSTIC I TABLE OF CONTENTS Foreword.......................................................................................................... 2 Annex 1: Selected References ................................... 39 Abbreviations ................................................................................................. 3 Annex 2: FHI 360 Health System Framework ....... 41 Annex 3: Rapid Diagnostic Project Participants . 42 1. Introduction ................................................................................................ 4 Annex 4: Self-Assessment Form .............................. 43 2. Detailed Guidance on the Steps ........................................................... 8 Annex 5: Common Sources for Data ....................... 44 PHASE I: PREPARING FOR THE RAPID DIAGNOSTIC ................ 9 Annex 6: Performance Metrics Table Template .. 48 Step 1) Draft the purpose and scope of the diagnostic .... 9 Annex 7: Kenya’s Indicator Dashboard ................... 49 Step 2) Gain buy-in and recruit partners ............................. 10 Annex 8: Methods for Prioritizing Ideas ................. 51 Step 3) Recruit a core team ..................................................... 10 Annex 9: Illustrative Collection
    [Show full text]