Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission

抑制治疗对 HSV-2 传播行为决定因素的影响

• 批准号: 7617062
• 负责人: KAREN ELIZABETH MARK
• 金额: $ 12.64万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2010-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7617062
• 关键词: Acyclovir; Address; Adherence; Adult; Adverse effects; Antibodies; Antiviral Agents; Antiviral Therapy; Behavior; Behavioral; Chronic; Clinical; Clinical Trials; Computers; Conflict (Psychology); Couples; Data; Detection; Disclosure; Disinhibition; Distress; Dose; Epidemiology; Female; Frequencies; Gender; Genital system; HIV Infections; Health; Heterosexuals; Human Herpesvirus 2; Infection; Internet; Lead; Measures; Mediating; Modality; Modeling; Mothers; Outcome; Participant; Patient Self-Report; Persons; Population; Prevalence; Prevention; Prevention strategy; Preventive Intervention; Principal Investigator; Randomized; Randomized Clinical Trials; Recording of previous events; Recurrence; Refusal to Participate; Reporting; Research Personnel; Risk; Sampling; Sex Behavior; Sexual Partners; Sexually Transmitted Diseases; Simplexvirus; Social Desirability; Source; Upper arm; Vagina; Validity of Self Report; Viral; Virus; Woman; Y Chromosome; base; behavior change; career development; condoms; consistent condom use; diaries; effective therapy; experience; genital herpes; high risk sexual behavior; men; neonate; open label; pill; placebo controlled study; population based; programs; psychosocial; sex; sexual encounter; sexually active; transmission process; treatment adherence; valacyclovir

DESCRIPTION (provided by applicant): Twenty-two percent of the U.S. adult population has antibodies to herpes simplex virus type 2 (HSV-2), indicating chronic infection with the most common virus causing genital herpes. Strategies for the prevention of HSV-2 transmission among sexually active persons remain limited and appear only partially protective. Such strategies include both biomedical (antiviral therapy of the source partner) and behavioral, such as condom use, disclosure of HSV-2 serostatus, and limiting the frequency of sexual encounters or the number of partners. Daily treatment of source partners with valacyclovir in a placebo-controlled trial in HSV-2 discordant couples decreased transmission by 50%. However, a person taking daily antiviral suppressive therapy to reduce the risk of transmission might be less likely to disclose their HSV status to a partner or use condoms, and/or have more frequent sexual encounters or more sexual partners. Thus, on a population basis the beneficial effect of source partner suppressive therapy in reducing transmission could potentially be outweighed by a detrimental effect on sexual behavior. If no such detrimental effect were found, and if acceptability and adherence to daily suppressive therapy for transmission prevention were high, then this prevention modality could be promoted with increased confidence. We plan to conduct an open-label randomized clinical trial of daily suppressive acyclovir versus episodic acyclovir for treatment of genital herpes recurrences among HSV-2 seropositive heterosexual men and women. We hypothesize that HSV-2 seropositive single heterosexuals randomized to antiviral suppressive therapy will be no more likely to engage in risky sexual behavior than those randomized to episodic treatment, and that adherence to suppressive therapy will be high. Participants will be followed for 1 year to assess disclosure of HSV-2 status to sex partners, number of sex partners, frequency of sexual activity, condom use, and adherence to therapy. These outcomes will be measured by self-report in a confidential, computer-based assessment, supplemented by pill counts for adherence. We will then model the potentially conflicting effects of suppressive therapy and sexual behavior change on population-level prevalence of HSV-2. This project, combined with related career development activities, will enable the Principal Investigator to gain valuable clinical trial experience and achieve independence as a clinical researcher in the field of sexually transmitted diseases.

描述（由申请人提供）：22%的美国成年人有2型单纯疱疹病毒（HSV-2）抗体，表明慢性感染了最常见的导致生殖器疱疹的病毒。在性活跃人群中预防2型单纯疱疹病毒传播的战略仍然有限，而且似乎只有部分保护作用。这些策略包括生物医学（对源性伴侣进行抗病毒治疗）和行为，如使用安全套、披露2型单纯疱疹病毒血清状态，以及限制性接触的频率或性伴侣的数量。在一项安慰剂对照试验中，在HSV-2不一致的夫妇中，源性伴侣每日使用伐昔洛韦治疗可减少50%的传播。然而，每天接受抗病毒抑制治疗以降低传播风险的人可能不太可能向伴侣透露他们的HSV状况或使用避孕套，并且/或者有更频繁的性接触或更多的性伴侣。因此，在人群基础上，源性伴侣抑制疗法在减少传播方面的有益效果可能会被对性行为的有害影响所抵消。如果没有发现这种有害影响，如果每日抑制治疗预防传播的可接受性和依从性很高，那么这种预防方式可以更有信心地推广。我们计划开展一项开放标签随机临床试验，比较每日抑郁性阿昔洛韦与发作性阿昔洛韦治疗HSV-2血清阳性异性恋男性和女性生殖器疱疹复发。我们假设，随机接受抗病毒抑制治疗的HSV-2血清阳性的单身异性恋者不会比随机接受间歇性治疗的人更容易发生危险的性行为，并且对抑制治疗的依从性将很高。参与者将被随访1年，以评估向性伴侣披露HSV-2状况、性伴侣数量、性活动频率、避孕套使用情况和治疗依从性。这些结果将在保密的、基于计算机的评估中通过自我报告来衡量，并辅以服药计数来衡量依从性。然后，我们将模拟抑制治疗和性行为改变对人群水平HSV-2患病率的潜在冲突影响。这个项目，结合相关的职业发展活动，将使首席研究员获得宝贵的临床试验经验，并在性传播疾病领域实现独立的临床研究。