Karine Dubé1, John Kanazawa1, Lynda Dee2,3,4, Jeff Taylor3,4,5,6, Danielle M Campbell3,4,7, Brandon Brown8, Mallory O Johnson9, Parya Saberi9, John A Sauceda9, Jeremy Sugarman10, Michael J Peluso11. 1. Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. 2. AIDS Action Baltimore, Baltimore, MD, USA. 3. Delaney AIDS Research Enterprise (DARE) CAB, San Francisco, CA, USA. 4. Martin Delaney Collaboratory Community Advisory Board, Nationwide, Baltimore, MD, USA. 5. HIV + Aging Research Project - Palm Springs (HARP-PS), Palm Springs, CA, USA. 6. AntiViral Research Center (AVRC) CAB, University of California San Diego, San Diego, CA, USA. 7. Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA. 8. Department of Social Medicine, Population and Public Health, Center for Healthy Communities, University of California, Riverside, Riverside, CA, USA. 9. Center for AIDS Prevention Studies (CAPS), Division of Prevention Sciences, UCSF, San Francisco, CA, USA. 10. Johns Hopkins Berman Institute for Bioethics, Baltimore, MD, USA. 11. Division of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, CA, USA.
Abstract
BACKGROUND: Background: Analytical treatment interruptions (ATIs) in HIV cure-related research can result in trial participants becoming viremic with HIV, placing HIV-negative sexual partners at elevated risk of acquiring HIV. OBJECTIVE: Objective:Our study aimed to generate ethical and practical considerations for designing and implementing appropriate risk mitigation strategies to reduce unintended HIV transmission events during ATIs. METHODS: Methods: We conducted 21 in-depth interviews with five types of informants: bioethicists, community members, biomedical HIV cure researchers, socio-behavioral scientists/epidemiologists, and HIV care providers. We used conventional content analysis to analyze the data and generate considerations. RESULTS: Results: Key findings include: 1) Ethical permissibility of ATI trials depends on due diligence and informed consent to mitigate risks to participants and their sexual partners; 2) Participants should receive adequate support and/or counseling if they choose to disclose ATI participation to their partners; 3) Measures to protect sexual partners of trial participants from HIV transmission during ATIs should include referral to and/or provision of pre-exposure prophylaxis, as well as other available means of preventing HIV transmission; 4) There is uncertainty regarding the appropriate management of emerging sexually transmitted infections during ATI trials and possible protection measures for multiple and/or anonymous partners of ATI trial participants. CONCLUSION: Conclusion: While there is no way to completely eliminate the risk of HIV transmission to sexual partners during ATIs, HIV cure trialists and sponsors should consider the ethical concerns related to the sexual partners of ATI participants. Doing so is essential to ensuring the welfare of participants, their partners and the trustworthiness of research.
BACKGROUND: Background: Analytical treatment interruptions (ATIs) in HIV cure-related research can result in trial participants becoming viremic with HIV, placing HIV-negative sexual partners at elevated risk of acquiring HIV. OBJECTIVE: Objective:Our study aimed to generate ethical and practical considerations for designing and implementing appropriate risk mitigation strategies to reduce unintended HIV transmission events during ATIs. METHODS: Methods: We conducted 21 in-depth interviews with five types of informants: bioethicists, community members, biomedical HIV cure researchers, socio-behavioral scientists/epidemiologists, and HIV care providers. We used conventional content analysis to analyze the data and generate considerations. RESULTS: Results: Key findings include: 1) Ethical permissibility of ATI trials depends on due diligence and informed consent to mitigate risks to participants and their sexual partners; 2) Participants should receive adequate support and/or counseling if they choose to disclose ATI participation to their partners; 3) Measures to protect sexual partners of trial participants from HIV transmission during ATIs should include referral to and/or provision of pre-exposure prophylaxis, as well as other available means of preventing HIV transmission; 4) There is uncertainty regarding the appropriate management of emerging sexually transmitted infections during ATI trials and possible protection measures for multiple and/or anonymous partners of ATI trial participants. CONCLUSION: Conclusion: While there is no way to completely eliminate the risk of HIV transmission to sexual partners during ATIs, HIV cure trialists and sponsors should consider the ethical concerns related to the sexual partners of ATI participants. Doing so is essential to ensuring the welfare of participants, their partners and the trustworthiness of research.
Entities:
Keywords:
HIV; HIV cure research; analytical treatment interruptions; partner protection; people living with HIV; risk mitigation
Authors: Boris Julg; Lynda Dee; Jintanat Ananworanich; Dan H Barouch; Katharine Bar; Marina Caskey; Donn J Colby; Liza Dawson; Krista L Dong; Karine Dubé; Joseph Eron; John Frater; Rajesh T Gandhi; Romas Geleziunas; Philip Goulder; George J Hanna; Richard Jefferys; Rowena Johnston; Daniel Kuritzkes; Jonathan Z Li; Udom Likhitwonnawut; Jan van Lunzen; Javier Martinez-Picado; Veronica Miller; Luis J Montaner; Douglas F Nixon; David Palm; Giuseppe Pantaleo; Holly Peay; Deborah Persaud; Jessica Salzwedel; Karl Salzwedel; Timothy Schacker; Virginia Sheikh; Ole S Søgaard; Serena Spudich; Kathryn Stephenson; Jeremy Sugarman; Jeff Taylor; Pablo Tebas; Caroline T Tiemessen; Randall Tressler; Carol D Weiss; Lu Zheng; Merlin L Robb; Nelson L Michael; John W Mellors; Steven G Deeks; Bruce D Walker Journal: Lancet HIV Date: 2019-03-15 Impact factor: 12.767
Authors: Mariya V Sivay; Philip J Palumbo; Yinfeng Zhang; Vanessa Cummings; Xu Guo; Erica L Hamilton; Laura McKinstry; Arthur Ogendo; Noel Kayange; Ravindre Panchia; Karen Dominguez; Ying Q Chen; Theodorus G M Sandfort; Susan H Eshleman Journal: Clin Infect Dis Date: 2021-07-01 Impact factor: 9.079
Authors: Karine Dubé; John Kanazawa; Christopher Roebuck; Steven Johnson; William B Carter; Lynda Dee; Beth Peterson; Kenneth M Lynn; Linden Lalley-Chareczko; Emily Hiserodt; Sukyung Kim; Daniel Rosenbloom; Brad R Evans; Melanie Anderson; Daria J Hazuda; Lisa Shipley; Kevin Bateman; Bonnie J Howell; Karam Mounzer; Pablo Tebas; Luis J Montaner Journal: HIV Res Clin Pract Date: 2022-03-29
Authors: Karine Dubé; Shadi Eskaf; Liz Barr; David Palm; Evelyn Hogg; Jane M Simoni; Jeremy Sugarman; Brandon Brown; John A Sauceda; Laney Henley; Steven Deeks; Lawrence Fox; Rajesh T Gandhi; Davey Smith; Jonathan Z Li Journal: AIDS Res Hum Retroviruses Date: 2022-04-21 Impact factor: 1.723
Authors: Karine Dubé; Shadi Eskaf; Elizabeth Hastie; Harsh Agarwal; Laney Henley; Christopher Roebuck; William B Carter; Lynda Dee; Jeff Taylor; Derrick Mapp; Danielle M Campbell; Thomas J Villa; Beth Peterson; Kenneth M Lynn; Linden Lalley-Chareczko; Emily Hiserodt; Sukyung Kim; Daniel Rosenbloom; Brad R Evans; Melanie Anderson; Daria J Hazuda; Lisa Shipley; Kevin Bateman; Bonnie J Howell; Karam Mounzer; Pablo Tebas; Luis J Montaner Journal: J Pers Med Date: 2022-02-07
Authors: Karine Dubé; John Kanazawa; Hursch Patel; Michael Louella; Laurie Sylla; Jeff Sheehy; Lynda Dee; Jeff Taylor; Jen Adair; Kim Anthony-Gonda; Boro Dropulić; John A Sauceda; Michael J Peluso; Steven G Deeks; Jane Simoni Journal: BMC Med Ethics Date: 2022-04-09 Impact factor: 2.834
Authors: Danielle M Campbell; Karine Dubé; Portia D Cowlings; Patricia Dionicio; Rowena M Tam; Harsh Agarwal; Jamila K Stockman; Judith D Auerbach; John A Sauceda; Amy A Conroy; Mallory O Johnson Journal: BMC Public Health Date: 2022-07-09 Impact factor: 4.135
Authors: Karine Dubé; John Kanazawa; Jeff Taylor; Lynda Dee; Nora Jones; Christopher Roebuck; Laurie Sylla; Michael Louella; Jan Kosmyna; David Kelly; Orbit Clanton; David Palm; Danielle M Campbell; Morénike Giwa Onaiwu; Hursch Patel; Samuel Ndukwe; Laney Henley; Mallory O Johnson; Parya Saberi; Brandon Brown; John A Sauceda; Jeremy Sugarman Journal: BMC Med Ethics Date: 2021-06-30 Impact factor: 2.834