Ethical and practical considerations for mitigating risks to sexual partners during analytical treatment interruptions in HIV cure-related research

References

• Prevention Access Campaign. U = U. https://www.preventionaccess.org/
   Google Scholar
• Julg B, Dee L, Ananworanich J, et al. Recommendations for analytical antiretroviral treatment interruptions in HIV research trials—report of a consensus meeting. Lancet Hiv. 2019;6(4):e259–e268.
   PubMed Web of Science ®Google Scholar
• Peluso MJ, Dee L, Campbell D, et al. Collaborative, multidisciplinary approach to HIV transmission risk mitigation during analytic treatment interruption. J Virus Erad. 2020;6(1):34–37.
   PubMed Web of Science ®Google Scholar
• Hardy DW. Analytical treatment interruptions and human immunodeficiency virus cure research: seizing the opportunity while maintaining safety and respect. Clin Infect Dis. 2020;70(7):1418–1420.
   Web of Science ®Google Scholar
• Sivay M, Palumbo P, Zhang Y, et al. HIV drug resistance, phylogenetic analysis, and superinfection among men who have sex with men and transgender women in Sub-Saharan Africa: HPTN 075. Clin Infect Dis. 2020.
   Google Scholar
• Eyal N, Deeks SG. Risk to nonparticipants in HIV remission studies with treatment interruption: a symposium. J Infect Dis. 2019;220:1–4.
   Web of Science ®Google Scholar
• Eyal N, Lipsitch M, Bärnighausen T, Wikler D. Opinion: risk to study nonparticipants: a procedural approach. Proc Natl Acad Sci USA. 2018;115(32):8051–8053.
   Web of Science ®Google Scholar
• Dawson L. Human immunodeficiency virus transmission risk in analytical treatment interruption studies: relational factors and moral responsibility. J Infect Dis. 2019;220(Suppl 1):S12–S15.
   PubMedGoogle Scholar
• Lelièvre JD, Hocqueloux L. Unintended HIV-1 transmission to a sex partner in a study of a therapeutic vaccine candidate. J Infect Dis. 2019;
   Google Scholar
• Palich R, Ghosn J, Chaillon A, et al. Viral rebound in semen after antiretroviral treatment interruption in an HIV therapeutic vaccine double-blind trial. Aids. 2019;33(2):279–284.
   Web of Science ®Google Scholar
• Lelièvre J-D. Preexposure prophylaxis for mitigating risk of HIV transmission during HIV cure – related clinical trials with a treatment interruption. J Infect Dis. 2019;12:1–3.
   Google Scholar
• Ugarte A, Romero Y, Tricas A, Casado C, Garcia F, Leal L. Unintended HIV-1 infection during analytical treatment interruption. J Infect Dis. 2019.
   Web of Science ®Google Scholar
• Eyal N. How to address the risk of HIV transmission in remission studies with treatment interruption: the low-hanging fruit approach. J Infect Dis. 2019;220(Suppl 1):S7–S11.
   PubMedGoogle Scholar
• Eyal N, Magalhaes M. Is it ethical to isolate study participants to prevent HIV transmission during trials with an analytical treatment interruption? J Infect Dis. 2019;220(Suppl 1):S19–S21.
   Google Scholar
• Eyal N. Removing one barrier to protecting sex partners in HIV remission studies with a treatment interruption. J Infect Dis. 2019;220(Suppl 1):S22–S3.
   Google Scholar
• TAG. Research toward a cure trials [Internet]. 2019. http://www.treatmentactiongroup.org/cure/trials
   Google Scholar
• Cresswell J. Research Design. Qualitative, Quantitative, and Mixed Methods Approaches. 4th ed. Thousand Oaks, CA: SAGE Publications; 2013.
   Google Scholar
• Grace D, Chown SA, Kwag M, Steinberg M, Lim E, Gilbert M. Becoming “undetectable”: longitudinal narratives of gay men's sex lives after a recent HIV diagnosis. AIDS Educ Prev. 2015;27(4):333–349.
   PubMed Web of Science ®Google Scholar
• Garner SA, Rennie S, Ananworanich J, Dubé K, et al. Interrupting antiretroviral treatment in HIV cure research: scientific and ethical considerations. J Virus Erad. 2017;3(2):82–84.
   PubMed Web of Science ®Google Scholar
• Sullivan PS, Mena L, Elopre L, Siegler AJ. Implementation strategies to increase PrEP uptake in the South. Curr HIV/AIDS Rep. 2019;16(4):259–269.
   Web of Science ®Google Scholar
• Dee L, Boone CA, Palm D, Campbell D, Dubé K. Secondary HIV infection and mitigation in cure-related HIV trials during analytical treatment interruptions. J Infect Dis. 2019;220:34–37.
   Web of Science ®Google Scholar
• UNAIDS. Ethical considerations in biomedical HIV prevention trials [Internet]. 2012. https://www.unaids.org/en/resources/documents/2012/20120701_jc1399_ethical_considerations
   Google Scholar
• Haire B, Folayan MO, Hankins C, et al. Ethical considerations in determining standard of prevention packages for HIV prevention trials: examining PrEP. Dev World Bioethic. 2013;13(2):87–94.
   PubMed Web of Science ®Google Scholar
• Sugarman J, Celum C, Donnell D, Mayer K. Ethical considerations for new HIV prevention trials. Lancet. 2019;6(8):e489-91–e491.
   Web of Science ®Google Scholar
• Sugarman J. Ethical considerations regarding oral preexposure prophylaxis in HIV prevention trials. Curr Opin HIV Aids. 2016;11(1):109–115.
   Web of Science ®Google Scholar
• Brown BJ, Sugarman J. Why ethics guidance needs to be updated for contemporary HIV prevention research. J Int AIDS Soc. 2020;23(5):e25500
   PubMed Web of Science ®Google Scholar
• Dawson L, Zwerski S. Clinical trial design for HIV prevention research: determining standards of prevention. Bioethics. 2015;29(5):316–323.
   Web of Science ®Google Scholar
• Kanazawa JT, Saberi P, Sauceda JA, Dubé K. The LAIs are coming! Implementation science considerations for long-acting injectable antiretroviral therapy in the United States: a scoping review. AIDS Res Hum Retroviruses. 2021;37(2):75–88.
   Web of Science ®Google Scholar
• Guest G, Bunce A, Johnson L. How many interviews are enough?: An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82.
   Web of Science ®Google Scholar
• Eyal N, Kuritzkes DR. Challenges in clinical trial design for HIV-1 cure research. Lancet. 2013;382(9903):1464–1465.
   PubMed Web of Science ®Google Scholar
• O'Dell BL, Rosser BRS, Miner MH, Jacoby SM. HIV prevention altruism and sexual risk behavior in HIV-positive men who have sex with men. AIDS Behav. 2008;12(5):713–720.
   PubMed Web of Science ®Google Scholar