VCT with Primary and Concurrent Partners to Prevent HIV Transmission

描述(由申请人提供)：在为未来的生物医学和行为干预试验做准备时，关键是要确定受益于当地最好、最负担得起的预防计划的高危人群中艾滋病毒的发病率。四分之三的非洲成年人在同居联盟中，那里发生了大多数新的感染病例。“一份爱”活动提倡一夫一妻制，但除非性伴侣中的两个人--无论是已婚的还是兼职的--都有相同的感染状态，否则忠诚并不能起到保护作用。在这项申请中，向赞比亚政府诊所的同居伴侣提供的夫妇自愿艾滋病毒咨询和检测(CVCT)将扩展到同时伴侣，并将衡量联合检测对联盟内外感染艾滋病毒发病率的影响。不和谐的夫妇对艾滋病毒预防研究至关重要：他们可以研究病毒学、免疫学和免疫遗传学的相关性，研究在男性到女性和女性到男性传播中的“传染性”和“脆弱性”，并测试艾滋病毒阳性和艾滋病毒携带者的生物医学和行为干预措施。对捐赠者和接受者传播的病毒进行比较，阐明了疫苗必须克服的选择过程。在东非和中非几个观察不一致的夫妇队列中，使用(3.5/100 Py)和不使用(10.2/100 Py)CVCT的艾滋病毒发病率进行比较，估计减少了三分之二。在赞比亚卢萨卡接受咨询的不和谐夫妇中，配偶之间的艾滋病毒发病率为6/100PY，另外1.5/100PY是由同时伴侣感染的。只有一项针对未经咨询的赞比亚不和谐夫妇的小型研究发表，报告的发病率为21/100 PY，因此关于CVCT在南部非洲的影响大小存在较少共识。目的1将使用病毒基因组测试来检查CVCT前获得性感染的发生率和来源，并将量化CVCT对不和谐夫妇的预防效果。联合国艾滋病规划署和国土安全部的数据显示，大多数婚外接触都是与长期稳定的伴侣进行的。与同时伴侣的联合检测(CPT)对不和谐和和谐的阴性夫妇的婚外艾滋病毒感染的潜在影响尚未被探索。形成性评估阶段将在根据RO1 MH 66767开发的CVCT程序改编成CPT干预措施(目标2)之前进行。由研究小组管理的40家拥有CVCT服务的诊所将被随机分配提供CPT(目标3)。新婚外感染的发生率将在仅接受CVCT的诊所和接受CVCT+CPT的诊所进行比较。尽管有咨询和免费服务，但只有10%与HIV-男性伴侣不和的夫妇要求男性割礼(MC)。与CVCT一样，MC是当地负担得起且经过验证的预防策略，必须在未来的试验中提供给参与者。辅助目标4将在未来的试验中调查男性包皮环切术(MC)的障碍，以优化对伦理标准的遵守。

DESCRIPTION (provided by applicant): In preparation for future trials of biomedical and behavioral interventions, it is critical to establish HIV incidence in high risk cohorts who have benefited from the best, most affordable prevention programs available to them locally. Three-quarters of African adults are in cohabiting unions, where most new infections occur. "One Love" campaigns promote monogamy, but unless both partners in a sexual dyad - whether married or concurrent - have the same infection status, being faithful is not protective. In this application, Couples' Voluntary HIV Counseling and Testing (CVCT) provided to cohabiting couples in Zambian government clinics will be extended to concurrent partners, and the impact of joint testing on incidence of HIV acquired within and outside the union will be measured. Discordant couples are critical to HIV prevention research: They allow study of virologic, immunologic and immunogenetic correlates of 'contagion' and 'vulnerability' in male-to-female and female-to-male transmission, and testing of biomedical and behavioral interventions in both HIV+ and HIV- partners. Comparison of transmitted viruses in donor and recipient clarify the selection process that a vaccine must overcome. Comparison of HIV incidence in several East-Central African observational discordant couple cohorts with (3.5/100 PY) and without (10.2/100 PY) CVCT yields an estimated reduction of two-thirds. In counseled discordant couples in Lusaka, Zambia, HIV incidence between spouses is 6/100 PY, and an additional 1.5/100 PY are infected by concurrent partners. Only one small published study of uncounseled Zambian discordant couples is available and reported an incidence of 21/100 PY, thus there is less consensus about the effect size of CVCT in southern Africa. Aim 1 will examine the incidence and origin of infections acquired prior to CVCT using viral genome testing and will quantify the prevention impact of CVCT in discordant couples. UNAIDS and DHS data indicate that most extramarital contacts are with longstanding steady partners. The potential impact of joint testing with concurrent partners (CPT) on HIV infections acquired outside marriage in both discordant and concordant negative couples has not been explored. A formative evaluation phase will precede development (Aim 2) of a CPT intervention adapted from CVCT procedures developed under RO1 MH 66767. Forty clinics with CVCT services managed by the research team will be randomized to provide CPT (Aim 3). The incidence of new infections acquired outside marriage will be compared in the CVCT only vs. CVCT+CPT clinics. Despite counseling and free services, only 10% of discordant couples with HIV- male partners request male circumcision (MC). Like CVCT, MC is a locally affordable and proven prevention strategy which must be offered to participants in future trials. Ancillary Aim 4 will investigate obstacles to male circumcision (MC) to optimize adherence with ethical standards in future trials.