A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial.
A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial.
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DOI：
10.1007/s10461-010-9853-2
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发表时间：
2011-07
影响因子：
4.4
通讯作者：
Celum, Connie
中科院分区：
文献类型：
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作者：
Jacob, Shevin T.;Baeten, Jared M.;Hughes, James P.;Peinado, Jesus;Wang, Jing;Sanchez, Jorge;Reid, Stewart E.;Delany-Moretlwe, Sinead;Cowan, Frances;Fuchs, Jonathan D.;Koblin, Beryl;Griffith, Sam;Wald, Anna;Celum, Connie
高依从性和保持盲法对于HIV-1生物医学预防策略的安慰剂对照有效性试验至关重要。我们评估了对研究药物的依从性和影响依从性的因素，包括感知的随机分组，在完成HPTN 039的参与者的试验后问卷调查中，HPTN 039是一项随机、安慰剂对照试验，旨在通过每日两次阿昔洛韦抑制HSV-2以减少HIV-1感染。在3172名试验参与者中，2003人（63%）完成了试验后问卷调查。在这2003例患者中，72%的患者报告缺失一剂研究药物，少于每周两次。在研究期间，研究药物依从性未受到感知的随机化或生殖器溃疡症状的影响。酒精使用被认为是一些人群的依从性障碍。在试验期间和试验结束时评估研究药物依从性可以评价随机化组对随机化和依从性的看法，有助于更好地了解依从性的障碍和动机，并制定干预措施以增加未来试验的依从性。
High adherence and maintenance of blinding are critical for placebo-controlled efficacy trials of HIV-1 biomedical prevention strategies. We assessed adherence to study drug and factors affecting adherence, including perceived randomization group, in a post-trial questionnaire of participants who completed HPTN 039, a randomized, placebo-controlled trial of HSV-2 suppression with twice-daily acyclovir to reduce HIV-1 acquisition. Of the 3172 trial participants, 2003 (63%) completed the post-trial questionnaire. Of these 2003, 72% reported missing a dose of study drug less than twice a week. Study drug adherence was not compromised by perceived randomization or genital ulcer symptoms during the study. Alcohol use was cited as an adherence barrier in some populations. Assessment of study drug adherence during and at the end of trials can evaluate perceptions of randomization and adherence by randomization arm, help to better understand barriers to and motivations for adherence, and develop interventions to increase adherence for future trials.
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DOI：
10.1056/nejmoa0800260
发表时间：
2008-04-10
期刊：
The New England journal of medicine
影响因子：
--
作者：
Watson-Jones D;Weiss HA;Rusizoka M;Changalucha J;Baisley K;Mugeye K;Tanton C;Ross D;Everett D;Clayton T;Balira R;Knight L;Hambleton I;Le Goff J;Belec L;Hayes R;HSV trial team;Steering and Data Monitoring Committees
通讯作者：
Steering and Data Monitoring Committees
影响因子：
168.9
作者：
Padian, Nancy S.;van der Straten, Ariane;McIntyre, James
通讯作者：
McIntyre, James
影响因子：
168.9
作者：
Celum, Connie;Wald, Anna;Corey, Lawrence
通讯作者：
Corey, Lawrence
影响因子：
2.3
作者：
Weiss, Helen A;Wasserheit, Judith N;Barnabas, Ruanne V;Hayes, Richard J;Abu-Raddad, Laith J
通讯作者：
Abu-Raddad, Laith J
影响因子：
168.9
作者：
Skoler-Karpoff, Stephanie;Ramjee, Gita;Lahteenmaki, Pekka
通讯作者：
Lahteenmaki, Pekka