Abstract
Many early phase HIV prevention studies define HIV risk-related eligibility criteria. We conducted a retrospective review of HIV Vaccine Trials Network (HVTN) Phase 1 and 2 HIV vaccine clinical trials completed in South Africa from 2003 to 2020, evaluating HIV incidence by protocol-defined risk criteria. Comparisons between groups controlled for age, gender and year of trial initiation. Across 12 trials, 1 did not specify risk criteria, and 11 specified various low risk criteria thematically categorized under sexual behaviors, clinical characteristics, and/or drug use behavior. Of the 11 trials, 6 used low sexual risk eligibility criteria standardized by the HVTN in 2009. Of the 1249 participants, median age 23.0 years, 66% were enrolled with the HVTN 2009 standardized low risk criteria, 15% using other sets of low risk criteria, and 19% using no risk criteria. Compared with the standardized low risk criteria group [2.3], HIV incidence per 100 person-years was significantly higher in the non-standardized low risk criteria group [5.0] and in the no risk criteria group [4.8]. In South Africa, cohorts with low HIV incidence can be identified primarily through sexual behavior and clinical characteristics.
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Data Availability
Data will be made publicly available at the public-facing HVTN website (https://atlas.scharp.org/).
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Acknowledgements
The authors wish to thank the trial participants, community members, the HVTN Core staff, the Statistical Center for HIV/AIDS Research & Prevention, the BARC and HVTN laboratories, the product developers and the HVTN Scientific Review Committee. We gratefully recognize the protocol chairs as representatives of vast teams of committed interdisciplinary researchers who led the protocols and/or implemented them at the research sites: Donald S Burke and Salim Abdool Karim (HVTN 040, HVTN 059); Scott Hammer (in memoriam) and James Kublin (HVTN 050/MRK018); Michael Keefer and Gavin Churchyard (HVTN 204); Glenda Gray and Kenneth Mayer (HVTN 073); Gavin Churchyard and Koleka Mlisana (HVTN 086); the HVTN 091/IAVI B003 team and Dagna Laufer; Glenda Gray and Surita Roux (HVTN 097); Linda-Gail Bekker and Fatima Laher (HVTN 100); Mina Hosseinipour, Sarita Naidoo and Craig Innes (HVTN 111); Paul Goepfert and Kathryn Mngadi (HVTN 107); Surita Roux, Nigel Garrett and Cynthia Monaco (HVTN 108). We thank Jessica Andriesen for facilitating access to the databases. In loving memory of the Soweto-Bara site Team Leader, Tshepiso Mbambisa, who had cared for the HVTN 107 and HVTN 108 participants. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), or the Gates Foundation.
Funding
The time of F.L. was funded by the National Institute of Allergy and Infectious Diseases (NIAID, https://www.niaid.nih.gov/) U.S. Public Health Service Grants UM1 AI069453 [Soweto-Bara Clinical Research Site].
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FL conceived the idea. FL and KO contributed to study design. FL and KO wrote the first draft of the manuscript. FL and KO analyzed the data. VOM collated risk data. MA performed data validation. All authors edited the manuscript with important intellectual content, and approved it.
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This study was approved by the University of the Witwatersrand Human Research Ethics Committee. Participants provided informed consent voluntarily and in writing for their respective clinical trials.
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Laher, F., Otwombe, K., Mokwena, O. et al. Use of Varied Screening Risk Criteria and HIV Incidence in Phase 1 and 2 HIV Vaccine Trials in South Africa. AIDS Behav 27, 1314–1320 (2023). https://doi.org/10.1007/s10461-022-03867-3
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DOI: https://doi.org/10.1007/s10461-022-03867-3