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在MTN-001研究中通过血浆药物水平测量的暴露前预防依从性：两个地理区域阴道凝胶与口服片剂的比较

Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions.

作者信息

Minnis Alexandra M, van der Straten Ariane, Salee Parichat, Hendrix Craig W

机构信息

Women's Global Health Imperative, RTI International, 351 California Street, Suite 500, San Francisco, CA, 94104, USA.

School of Public Health, University of California, Berkeley, USA.

出版信息

AIDS Behav. 2016 Jul;20(7):1541-8. doi: 10.1007/s10461-015-1081-3.

DOI:10.1007/s10461-015-1081-3
PMID:25969178
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4957649/
Abstract

Despite strong evidence that daily oral pre-exposure prophylaxis (PrEP) reduces HIV risk, effectiveness across studies has varied. Inconsistent adherence constitutes one explanation. Efforts to examine adherence are limited when they rely on self-reported measures. We examined recent adherence as measured by plasma tenofovir (TFV) concentration in participants of MTN-001, a phase 2 cross-over trial comparing oral tablet and vaginal gel formulations of TFV among 144 HIV-uninfected women at sites in the United States (U.S.) and sub-Saharan Africa (SSA). Adherence to daily product use was higher in the U.S. than in the SSA sites. Within region, however, adherence was similar between products. In the U.S., gel adherence was higher among married women, and lower among women using male condoms and injectable contraceptives. At the SSA sites, gel adherence was lower for younger women. Inconsistent adherence points to challenges in use of daily PrEP, even during a trial of short duration.

摘要

尽管有强有力的证据表明每日口服暴露前预防（PrEP）可降低感染艾滋病毒的风险，但不同研究的效果存在差异。依从性不一致是一种解释。当依赖自我报告的测量方法时，检查依从性的努力是有限的。我们通过血浆替诺福韦（TFV）浓度来检测MTN - 001参与者最近的依从性，MTN - 001是一项2期交叉试验，在美国（U.S.）和撒哈拉以南非洲（SSA）的多个地点，对144名未感染艾滋病毒的女性比较TFV的口服片剂和阴道凝胶制剂。美国每日产品使用的依从性高于撒哈拉以南非洲地区的地点。然而，在各地区内，不同产品之间的依从性相似。在美国，已婚女性使用凝胶的依从性较高，而使用男用避孕套和注射用避孕药的女性依从性较低。在撒哈拉以南非洲地区的地点，年轻女性使用凝胶的依从性较低。即使在短期试验期间，依从性不一致也表明每日使用PrEP存在挑战。

相似文献

[1]
Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions.

AIDS Behav. 2016-7

[2]
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AIDS Behav. 2013-2

[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[9]
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[10]
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引用本文的文献

[1]
Integration of HIV Prevention With Sexual and Reproductive Health Services: Evidence for Contraceptive Options and HIV Outcomes Study Experience of Integrating Oral Pre-exposure HIV Prophylaxis in Family Planning Services in Lusaka, Zambia.

Front Reprod Health. 2021-7-13

[2]
Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence.

BMC Womens Health. 2019-1-25

[3]
Associations between perceived barriers and benefits of using HIV pre-exposure prophylaxis and medication adherence among men who have sex with men in Western China.

BMC Infect Dis. 2018-11-15

[4]
Historical development of vaginal microbicides to prevent sexual transmission of HIV in women: from past failures to future hopes.

Drug Des Devel Ther. 2017-6-15

[5]
Superior Efficacy of a Human Immunodeficiency Virus Vaccine Combined with Antiretroviral Prevention in Simian-Human Immunodeficiency Virus-Challenged Nonhuman Primates.

J Virol. 2016-5-12

[6]
Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

AIDS Behav. 2016-11

[7]
Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study.

J Int AIDS Soc. 2016-2-4

[8]
Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States.

AIDS Behav. 2016-11

本文引用的文献

[1]
Engaging male partners in women's microbicide use: evidence from clinical trials and implications for future research and microbicide introduction.

J Int AIDS Soc. 2014-9-8

[2]
Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa.

PLoS One. 2014-2-21

[3]
Effects of partnership change on microbicide gel adherence in a clinical trial (HPTN 035).

AIDS Behav. 2014-5

[4]
Adherence challenges with drugs for pre-exposure prophylaxis to prevent HIV infection.

Int J Clin Pharm. 2014-2

[5]
Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa.

PLoS Med. 2013-9-10

[6]
Preparing for the unexpected: the pivotal role of social and behavioral sciences in trials of biomedical HIV prevention interventions.

J Acquir Immune Defic Syndr. 2013-7

[7]
Update to Interim Guidance for Preexposure Prophylaxis (PrEP) for the Prevention of HIV Infection: PrEP for injecting drug users.

MMWR Morb Mortal Wkly Rep. 2013-6-14

[8]
MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments.

PLoS One. 2013-1-30

[9]
Adherence to antiretroviral medications for HIV pre-exposure prophylaxis: lessons learned from trials and treatment studies.

Am J Prev Med. 2013-1

[10]
Methodological lessons from clinical trials and the future of microbicide research.

Curr HIV/AIDS Rep. 2013-3

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