Key stakeholders’ perspectives on providing oral pre-exposure prophylaxis as HIV-prevention standard of care in clinical trials in South Africa

References

• Beesham, I., Welch, J. D., Heffron, R., Pleaner, M., Kidoguchi, L., Palanee-Phillips, T., Ahmed, K., Baron, D., Bukusi, E. A., Louw, C., Mastro, T. D., Smit, J., Batting, J. R., Malahleha, M., Bailey, V. C., Beksinska, M., Donnell, D., Baeten, J. M., & ECHO Trial Consortium. (2020). Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial. Journal of the International AIDS Society, 23(5), e25491. https://doi.org/10.1002/jia2.25491
   PubMed Web of Science ®Google Scholar
• Brown, B., Sugarman, J., & the HPTN Ethics Working Group. (2020). HPTN Ethics Guidance for Research – Revised February 2020. https://www.hptn.org/sites/default/files/inline-files/HPTNEthicsGuidanceDocument_2.26.20.pdf
   Google Scholar
• Celum, C. L., Delany-Moretlwe, S., Baeten, J. M., van der Straten, A., Hosek, S., Bukusi, E. A., McConnell, M., Barnabas, R. V., & Bekker, L. G. (2019). HIV pre-exposure prophylaxis for adolescent girls and young women in Africa: from efficacy trials to delivery. Journal of the International AIDS Society, 22(S4), e25298. https://doi.org/10.1002/jia2.25298
   PubMed Web of Science ®Google Scholar
• Department of Health. (2022). myPrEP. Republic of South Africa. https://myprep.co.za/
   Google Scholar
• Gray, G. E., Bekker, L. G., Laher, F., Malahleha, M., Allen, M., Moodie, Z., Grunenberg, N., Huang, Y., Grove, D., Prigmore, B., Kee, J. J., Benkeser, D., Hural, J., Innes, C., Lazarus, E., Meintjes, G., Naicker, N., Kalonji, D., Nchabeleng, M., Sebe, M., & HVTN 702 Study Team. (2021). Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120-MF59 in adults. The New England Journal of Medicine, 384(12), 1089–1100. https://doi.org/10.1056/NEJMoa2031499
   PubMed Web of Science ®Google Scholar
• Janes, H., Donnell, D., Gilbert, P. B., Brown, E. R., & Nason, M. (2019). Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials. The Lancet HIV, 6(7), e475–e482. https://doi.org/10.1016/S2352-3018(19)30133-X
   PubMed Web of Science ®Google Scholar
• Joint United Nations Programme on HIV/AIDS and the World Health Organization (UNAIDS & WHO). (2021). Ethical considerations in HIV prevention trials. https://www.unaids.org/en/resources/documents/2021/ethical-considerations-in-hiv-prevention-trials
   Google Scholar
• Joseph Davey, D. L., Daniels, J., Beard, C., Mashele, N., Bekker, L. G., Dovel, K., Ncayiyana, J., Coates, T. J., & Myer, L. (2020). Healthcare provider knowledge and attitudes about pre-exposure prophylaxis (PrEP) in pregnancy in Cape Town, South Africa. AIDS Care, 32(10), 1290–1294. https://doi.org/10.1080/09540121.2020.1782328
   PubMed Web of Science ®Google Scholar
• Lanham, M., Ridgeway, K., Mireku, M., Nhamo, D., Pillay, D., Murire, M., Stankevitz, K., Kyongo, J., Mullick, S., & OPTIONS Consortium Research Team (2021). Health care providers’ attitudes toward and experiences delivering oral PrEP to adolescent girls and young women in Kenya, South Africa and Zimbabwe. BMC Health Services Research, 21(1), 1112. https://doi.org/10.1186/s12913-021-06978-0
   Google Scholar
• Miner, M. D., Bekker, L. G., Kredo, T., Bhagwandin, N., Corey, L., & Gray, G. E. (2021). Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle- Income Settings Summit, November 2017. Trials, 22(1), 778. https://doi.org/10.1186/s13063-021-05754-z
   PubMed Web of Science ®Google Scholar
• Ndase, P., Celum, C., Campbell, J., Bukusi, E., Kiarie, J., Katabira, E., Mugo, N., Tumwesigye, E., Wangisi, J., Were, E., Brantley, J., Donnell, D., & Baeten, J. M. (2014). Successful discontinuation of the placebo arm and provision of an effective HIV prevention product after a positive interim efficacy result: the partners PrEP study experience. Journal of Acquired Immune Deficiency Syndromes, 66(2), 206–212. https://doi.org/10.1097/QAI.0000000000000141
   PubMed Web of Science ®Google Scholar
• PrEP Watch. (2020). A snapshot of PrEP scale-up, registration and resources for South Africa. https://www.prepwatch.org/country/south-africa/
   Google Scholar
• Sidebottom, D., Ekström, A. M., & Strömdahl, S. (2018). A systematic review of adherence to oral pre-exposure prophylaxis for HIV - how can we improve uptake and adherence? BMC Infectious Diseases, 18(1), 581. https://doi.org/10.1186/s12879-018-3463-4
   PubMed Web of Science ®Google Scholar
• Singh, H., Rao, S. V., Kakkar, A. K., Singh, J., & Manohar, H. D. (2019). Post-trial access to medical interventions: intricacies, challenges, and solutions. International Journal of Applied & Basic Medical Research, 9(1), 3–8. https://doi.org/10.4103/ijabmr.IJABMR_218_18
   PubMedGoogle Scholar
• Sugarman, J., Donnell, D. J., Hanscom, B., McCauley, M., Grinsztejn, B., & Landovitz, R. J. (2021). Ethical issues in establishing the efficacy and safety of long-acting injectable pre-exposure prophylaxis for HIV prevention: the HPTN 083 trial. The Lancet HIV, 8(11), e723–e728. https://doi.org/10.1016/S2352-3018(21)00153-3
   PubMed Web of Science ®Google Scholar
• The South African Medical Research Council (SAMRC). (2017). Executive summary of the summit on the standard of care in clinical trials in low-middle income settings. https://www.samrc.ac.za/sites/default/files/publications/2019-01-17/ExecSumSummitStandardCare.pdf
   Google Scholar
• Treatment Action Group (TAG). (2017). HIV research in the era of PrEP: The implications of TDF/FTC for biomedical prevention trials. https://www.treatmentactiongroup.org/wp-content/uploads/2017/09/PrEP-Prevention-Trials-FINAL.pdf
   Google Scholar
• UNAIDS. (2021). Country fact sheets: South Africa. https://www.unaids.org/en/regionscountries/countries/southafrica
   Google Scholar
• UNAIDS. (2022). Core epidemiology slides. https://www.unaids.org/en/resources/documents/2022/core-epidemiology-slides
   Google Scholar
• World Health Organization . (2015). Policy brief: pre-exposure prophylaxis ( PrEP) : WHO expands recommendation on oral pre-exposure prophylaxis of HIV infection ( PrEP). https://apps.who.int/iris/handle/10665/197906
   Google Scholar
• World Health Organization. (2021). HIV/AIDS – Key Facts. https://www.who.int/news-room/fact-sheets/detail/hiv-aids
   Google Scholar
• Zimba, C., Maman, S., Rosenberg, N. E., Mutale, W., Mweemba, O., Dunda, W., Phanga, T., Chibwe, K. F., Matenga, T., Freeborn, K., Schrubbe, L., Vwalika, B., & Chi, B. H. (2019). The landscape for HIV pre-exposure prophylaxis during pregnancy and breastfeeding in Malawi and Zambia: A qualitative study. PloS One, 14(10), e0223487. https://doi.org/10.1371/journal.pone.0223487
   PubMed Web of Science ®Google Scholar