University of Pennsylvania, 418 Curie Blvd, Room 222L, Philadelphia, PA, 19104, USA.
Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
AIDS Behav. 2022 May;26(5):1333-1346. doi: 10.1007/s10461-021-03490-8. Epub 2021 Oct 17.
This study describes the acceptability of a rectal microbicide gel formulation using dapivirine (DPV) among men and women from two countries (United States and Thailand) participating in the Microbicide Trials Network-026 trial. We evaluated participants' acceptability of a rectal DPV/placebo gel as part of a Phase I trial (N = 26; 18 male, 8 female). Participants reported favorable acceptability of the study gel, with most participants reporting that they liked the gel the same (n = 14; 53.8%) or more (n = 11; 42.4%) than when they started the trial. Over half of participants noted that they would prefer the gel over condoms (n = 13; 50%) or that they liked condoms and the gel equally (n = 8; 30.8%). Side effects across products included leakage (n = 8; 30.8%), diarrhea (n = 4; 15.4%), or soiling (n = 1; 3.8%). The high acceptability of a rectal gel underscores its promise as a short-acting biomedical prevention, warranting future research for HIV prevention.Trial Registration: NCT03239483.
本研究描述了来自两个国家(美国和泰国)参与 Microbicide Trials Network-026 试验的男性和女性对含有 dapivirine(DPV)的直肠杀微生物剂凝胶制剂的可接受性。我们评估了参与者对直肠 DPV/安慰剂凝胶的可接受性,这是一项 I 期试验的一部分(N=26;18 名男性,8 名女性)。参与者报告了对研究凝胶的良好可接受性,大多数参与者表示他们喜欢凝胶的程度相同(n=14;53.8%)或更喜欢(n=11;42.4%)凝胶,而不是在试验开始时。超过一半的参与者表示,他们更喜欢凝胶而不是避孕套(n=13;50%),或者他们喜欢避孕套和凝胶的程度相同(n=8;30.8%)。两种产品的副作用包括渗漏(n=8;30.8%)、腹泻(n=4;15.4%)或弄脏(n=1;3.8%)。直肠凝胶的高可接受性突出了其作为一种短期作用的生物医学预防方法的潜力,值得进一步研究以预防 HIV。
NCT03239483。