Adherence, acceptability, preference and safety of placebo Long-Acting Pre-exposure Prophylaxis (LA-PrEP) injections and implants for HIV-Prevention in South African Men

作者：Elizabeth T. Montgomery, Thesla Palanee-Phillips, Millicent Atujuna, Chayla Hart, Erica N. Browne, Krishaveni Reddy, Katherine Gill, Alyssa J. Michaels, Nkosiphile Ndlovu, Pippa MacDonald, C Chappell, Sihle Zulu, Nomvuyo T. Mangxilana, Miranda Diaz, Linda-Gail Bekker, Alexandra M. Minnis · 发表于：AIDS · 年份：2026 · DOI：10.1097/qad.0000000000004563 · 研究领域：HIV-related health complications and treatments、HIV/AIDS Research and Interventions、HIV, Drug Use, Sexual Risk

BACKGROUND: Globally and in South Africa, cisgender men underutilize available effective HIV-prevention strategies. Early-stage research on emerging HIV prevention methods provide an opportunity to assess factors influencing the initiation and persistent use of novel drug delivery platforms for long-acting preexposure prophylaxis (LA-PrEP) among male users. METHODS: We conducted the SAMURAI randomized crossover study, where MSM and men who have sex only with women (MSW) in Cape Town and Johannesburg, South Africa, were administered placebo versions of bimonthly gluteal injections for six months and a six-month implant inserted in the inner upper arm in a randomized sequential order. We measured acceptability and defined adherence as the initiation and continued use of each product. We further monitored adverse events, serious adverse events (SAEs), injection/implant site reactions (ISRs), and social harms throughout the study and assessed LA-PrEP preference at study exit. FINDINGS: From July 2022 to June 2024, 184 cisgender men (n = 84 MSM, n = 100 MSW) were enrolled and retained with an 86% retention rate. More participants initiated injections than implants (97.8 vs. 91.3%, P = 0.007). Of those, 80.6% persisted with injections. For implants, 91.1% persisted (median 6.0 months, range 2.3-14.6), with 9% requesting early removal. Persistent use was significantly higher for implants (aRR 1.17, 95% CI: 1.07-1.27, P < 0.001). User satisfaction was high (injectables: 8.6, implants...