CVCTPlus: A Couples-Based Approach to Linkage to Care and ARV Adherence

描述（由申请人提供）：男男性行为者（MSM）仍然是美国艾滋病毒流行中受影响最严重的风险群体。研究表明，男男性行为者中的大多数艾滋病毒感染事件可归因于与主要男性性伴侣的性行为;然而，缺乏针对男男性伴侣的艾滋病毒预防干预措施。正因为如此，夫妇艾滋病毒自愿咨询和检测（CVCT），一个干预措施，已被多次证明，以减少艾滋病毒传播的异性恋夫妇，已被改编为美国男男性行为者夫妇。此外，新的证据表明，抗逆转录病毒疗法（ART）不仅降低了艾滋病毒阳性者的发病率和死亡率，而且还将艾滋病毒传播给阴性伴侣的风险降低了96%。由于对ART的依从性是可以改变的，并且同伴支持的水平已经显示出增加ART依从性，因此本研究提出使用CVCT结合二元依从性咨询（“CVTCPlus”）来改善HIV-血清不一致的男性-男性夫妇之间与护理的联系、护理中的保留、ART依从性和病毒抑制，使用亚特兰大、波士顿和芝加哥的250对血清不一致夫妇的队列。血清不一致的夫妇（每组125人）将被随访两年，每六个月进行一次研究访视。在每次访视时，HIV阴性伴侣将接受HIV检测，双方将完成一项研究调查，测量可能影响依从性的社会和行为因素，例如夫妇的应对能力及其对外部性伴侣的一致性，EMR提取将用于确定护理和病毒抑制的联系和保留。此外，干预组的夫妇将接受针对实时监测ART依从性（通过Wisepill）提供的数据的依从性咨询。研究人员假设这种基于夫妇的二元依从性干预将有助于增加ART依从性，护理中的联系和保留，以及病毒抑制的实现。了解血清不一致的男性夫妇中与病毒抑制进展相关的因素，以及旨在增加联系、保留和抗逆转录病毒药物依从性的干预措施的有效性，对于制定和推出以夫妇为重点的艾滋病毒预防工作至关重要。

DESCRIPTION (provided by applicant): Men who have sex with men (MSM) continue to be the most heavily-impacted risk group in the US HIV epidemic. Studies suggest that the majority of incident HIV infections among MSM are attributable to sex with a main male sex partner; however, HIV prevention interventions that target male-male couples are lacking. Because of this, Couples HIV Voluntary Counseling and Testing (CVCT), an intervention that has been repeatedly shown to reduce HIV transmission within heterosexual couples, has been adapted to US MSM couples. Additionally, novel evidence demonstrates that antiretroviral therapy (ART) not only reduces morbidity and mortality among HIV-positive persons, but also serves to reduce the risk of HIV transmission to a negative partner by 96%. As adherence to ART is modifiable, and levels of peer support have been shown to increase ART adherence, this current study proposes to use CVCT combined with dyadic adherence counseling ("CVTCPlus") to improve linkage to care, retention in care, ART adherence and viral suppression among HIV- sero-discordant male-male couples using a cohort of 250 serodiscordant couples in Atlanta, Boston, and Chicago. Sero-discordant couples (125 in each arm) will be followed for two years, with study visits every six months. At each visit, the HIV-negative partner will be tested for HIV and both partners will complete a study survey measuring social and behavioral factors that may influence adherence, such as a couple's coping ability and their concordance of agreements regarding outside sex partners, and EMR extraction will be used to identify linkage and retention in care and viral suppression. Additionally, couples in the intervention arm will receive adherence counseling specific to data provided by real-time monitoring of ART adherence (via Wisepill). The researchers hypothesize such a couples-based, dyadic adherence intervention will serve to increase ART adherence, linkage and retention in care, and achievement of viral suppression. Understanding of the factors associated with progression towards viral suppression among sero-discordant male couples, and the effectiveness of an intervention aimed at increasing linkage, retention and ARV adherence is vital to inform the development and roll-out of couples'-focused HIV prevention efforts.