High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women.
High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women.
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DOI：
10.1371/journal.pone.0181607
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发表时间：
2017
期刊：
影响因子：
3.7
通讯作者：
Cranston RD
中科院分区：
文献类型：
--
作者：
Carballo-Diéguez A;Balán IC;Brown W 3rd;Giguere R;Dolezal C;Leu CS;Marzinke MA;Hendrix CW;Piper JM;Richardson BA;Grossman C;Johnson S;Gomez K;Horn S;Kunjara Na Ayudhya RP;Patterson K;Jacobson C;Bekker LG;Chariyalertsak S;Chitwarakorn A;Gonzales P;Holtz TH;Liu A;Mayer KH;Zorrilla C;Lama J;McGowan I;Cranston RD
评估杀微生物剂安全性的试验要求严格遵守规定的方案。如果依从性不够理想，则不能充分评估安全性。MTN-017是一项2期、随机序列、开放标签、扩大安全性和可接受性的交叉研究，比较了1)每日口服恩曲他滨/富马酸替诺福韦二氧吡酯（FTC/TDF）， 2)每日直肠使用1%替诺福韦（RG-TFV）凝胶，3)接受性肛交（RAI）前后使用RG-TFV凝胶，如果参与者在一周内没有发生RAI，他们被要求在24小时内使用两剂凝胶。通过混合方法评估产品使用情况，包括未使用产品退货计数、短信报告和定性血浆TFV药代动力学（PK）结果。汇聚性访谈让参与者根据产品数量和短信报告确定最准确的剂量。还使用了以客户为中心的依从性咨询。参与者（N = 187）是在美国（42%）、泰国（29%）、秘鲁（19%）和南非（10%）登记的男男性行为者和变性女性。平均年龄31.4岁（18-64岁）。基于收敛访谈，在8周的时间内，94%的参与者每日服药依从性≥80%，41%完全依从；83%的患者每日凝胶依从性≥80%，29%的患者完全依从；在RAI相关凝胶方案中，93%的患者每周使用两次的依从性≥80%，75%的患者完全依从，77%的患者在RAI前后使用凝胶的依从性≥80%。只有4.4%的每日产品PK结果是不可检测的和意外的（TFV浓度<0.31 ng/mL），因为自我报告的产品使用接近采样日期。混合方法的依从性测量表明，在所有三种方案中，产品使用的依从性很高。使用与rai相关的直肠凝胶的依从性与每日口服PrEP的依从性一样高。直肠杀微生物剂凝胶如果有效，可能是对每日口服PrEP不感兴趣的个体的替代选择。
Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)—if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18–64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ≥80% adherence to daily tablet, 41% having perfect adherence; 83% had ≥80% adherence to daily gel, 29% having perfect adherence; and 93% had ≥80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ≥80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP.
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影响因子：
11.8
作者：
Cranston, Ross D.;Lama, Javier R.;McGowan, Ian
通讯作者：
McGowan, Ian
影响因子：
4.4
作者：
Carballo-Dieguez, Alex;Giguere, Rebecca;Dolezal, Curtis;Bauermeister, Jose;Leu, Cheng-Shiun;Valladares, Juan;Frasca, Timothy;Labbett, Rita;Cranston, Ross D.;Febo, Irma;Mayer, Kenneth;McGowan, Ian
通讯作者：
McGowan, Ian
DOI：
10.1097/qai.0000000000000172
发表时间：
2014-07-01
期刊：
Journal of acquired immune deficiency syndromes (1999)
影响因子：
--
作者：
Donnell D;Baeten JM;Bumpus NN;Brantley J;Bangsberg DR;Haberer JE;Mujugira A;Mugo N;Ndase P;Hendrix C;Celum C
通讯作者：
Celum C
影响因子：
4.6
作者：
Stirratt, Michael J;Gordon, Christopher M
通讯作者：
Gordon, Christopher M
影响因子：
4.4
作者：
Leu, Cheng-Shiun;Mabragana, Marina;Giguere, Rebecca;Dolezal, Curtis;Carballo-Dieguez, Alex;McGowan, Ian
通讯作者：
McGowan, Ian