Morris Sheldon R, Jain Sonia, Blumenthal Jill, Bolan Robert, Dubé Michael P, Henderson Philip, Corado Katya, Sun Shelly, He Feng, Chow Karen, Burke Leah, Anderson Peter L, Moore David J
University of California, San Diego, CA.
Los Angeles LGBT Center, Los Angeles, CA.
J Acquir Immune Defic Syndr. 2022 Dec 15;91(5):453-459. doi: 10.1097/QAI.0000000000003091.
Transgender and nonbinary individuals at risk for HIV may benefit from adherence support for pre-exposure prophylaxis.
Between June 2017 and September 2020, 255 transgender and nonbinary individuals received daily oral tenofovir disoproxil fumarate/emtricitabine for 48 weeks randomized 1:1 to receive individualized Texting for Adherence Building (iTAB) or iTAB plus motivational interviewing (iTAB + MI) through phone for nonadherence. The primary end point was dried blood spot tenofovir diphosphate concentrations at weeks 12 and 48 (or last on-drug study visit) ≥1246 fmol/punch consistent with ≥7 doses/week (ie, near-perfect adherence). Secondary outcomes included dried blood spot tenofovir diphosphate concentrations ≥719 fmol/punch consistent with ≥4 doses/week (ie, adequate adherence) and self-reported adherence by daily text messages.
Adherence for the outcome ≥1246 fmol/punch and ≥719 fmol/punch, respectively, was 49.1% and 57.9% for transgender men, 37.7% and 47.2% for nonbinary individuals, and 31.0% and 44.1% for transgender women. No difference was seen in iTAB + MI compared with iTAB alone by drug levels except where it approached significance in transgender women for the outcome of ≥719 fmol/punch in the iTAB + MI group compared with iTAB only (52% versus 35.7%, P = 0.065). There was a significant difference in self-reported daily dose adherence in the iTAB + MI group compared with iTAB alone (57.9% of days versus 46.4%, P = 0.009). In transgender women, the mean percentage of daily doses taken was 58.5% with iTAB + MI and 37.3% with iTAB alone ( P < 0.001).
In addition to automated approaches to adherence promotion, phone-based MI triggered by repeatedly missing doses may improve pre-exposure prophylaxis adherence among transgender women.
有感染艾滋病毒风险的跨性别者和非二元性别者可能会从暴露前预防的依从性支持中受益。
在2017年6月至2020年9月期间，255名跨性别者和非二元性别者每天口服替诺福韦酯富马酸盐/恩曲他滨，为期48周，按1:1随机分组，接受个性化的短信增强依从性（iTAB）或iTAB加动机性访谈（iTAB + MI），通过电话处理不依从情况。主要终点是第12周和第48周（或最后一次服药研究访视）时干血斑中替诺福韦二磷酸浓度≥1246 fmol/打孔，这与每周≥7剂（即近乎完美的依从性）一致。次要结局包括干血斑中替诺福韦二磷酸浓度≥719 fmol/打孔，这与每周≥4剂（即足够的依从性）一致，以及通过每日短信自我报告的依从性。
对于跨性别男性，达到≥1246 fmol/打孔和≥719 fmol/打孔结局的依从性分别为49.1%和57.9%；对于非二元性别者，分别为37.7%和47.2%；对于跨性别女性，分别为31.0%和44.1%。与单独使用iTAB相比，iTAB + MI在药物水平上未见差异，但在跨性别女性中，iTAB + MI组与仅使用iTAB组相比，在≥719 fmol/打孔结局方面接近显著差异（52%对35.7%，P = 0.065）。与单独使用iTAB相比，iTAB + MI组在自我报告的每日剂量依从性方面存在显著差异（分别为57.9%的天数对46.4%，P = 0.009）。在跨性别女性中，iTAB + MI组每日服用剂量的平均百分比为58.5%，而单独使用iTAB组为37.3%（P < 0.001）。
除了采用自动化方法促进依从性外，因多次漏服药物而触发的基于电话的动机性访谈可能会提高跨性别女性暴露前预防的依从性。
