VCT with Primary and Concurrent Partners to Prevent HIV Transmission

与主要和同时性伴侣进行 VCT，以预防 HIV 传播

• 批准号: 8602859
• 负责人: Susan A Allen
• 金额: $ 51.24万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-21 至 2016-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8602859
• 关键词: AIDS Vaccines; AIDS prevention; Adherence; Adult; Advocacy; Africa; African; Antibodies; Attitude; Behavior Therapy; Biological Assay; Cities; Clinic; Clinical Trials; Comprehension; Consensus; Counseling; Couples; DNA; Data; Data Collection; Detection; Development; Enzyme-Linked Immunosorbent Assay; Epidemic; Epidemiology; Ethics; Evaluation; Family; Female; Frequencies; Funding; Future; Goals; Government; HIV; HIV Infections; HIV risk; Immunogenetics; Immunologics; Immunology; Incidence; Infection; International; International AIDS; Intervention; Joints; Laboratories; Male Circumcision; Marriage; Measures; Nature; Nurses; Participant; Phase; Polygamy; Preparation; Prevention; Prevention Research; Prevention program; Prevention strategy; Procedures; Process; Professional counselor; Prostitution; Province; Publishing; RNA; Randomized; Reporting; Research; Rwanda; Sample Size; Sampling; Seasons; Services; Site; Southern Africa; Spouses; Testing; Vaccines; Viral Genome; Virus; Visit; Wife; Woman; Zambia; base; cohort; contagion; efficacy testing; experience; group intervention; high risk; loved ones; male; men; prevent; professor; service intervention; sex; tool; transmission process; urban area; virology

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.

描述（由申请人提供）：在为将来的生物医学和行为干预措施试验做准备时，至关重要的是，在高风险同伙中建立艾滋病毒发病率，这些艾滋病毒发病率从当地可用的最佳，最负担得起的预防计划中受益。非洲成年人的四分之三是同居工会，大多数新感染。 “一个爱”运动促进了一夫一妻制，但是除非性二元组中的两个伴侣（无论是已婚还是并发）具有相同的感染状态，否则忠实的忠实是没有保护的。在本申请中，夫妇的自愿艾滋病毒咨询和测试（CVCT）将扩展到赞比亚政府诊所的同居夫妇并发伴侣，并将测量联合测试对收到联盟内部和外部HIV发生率的影响。 不一致的夫妻对艾滋病毒的预防研究至关重要：他们允许研究男性到女性和女性传播中“传染”和“脆弱性”的病毒学，免疫和免疫遗传学相关性，以及在HIV+和HIV伴侣中测试生物医学和行为干预措施。供体和受体中传播病毒的比较阐明了疫苗必须克服的选择过程。 与（3.5/100 py）和没有（10.2/100 py）CVCT的几个东部非洲观察夫妇队列中HIV发病率的比较可导致估计减少三分之二。在赞比亚卢萨卡（Lusaka）的不和谐夫妇中，配偶之间的艾滋病毒发病率为6/100 PY，另外1.5/100 PY被并发伴侣感染。只有一项针对毫无疑问的赞比亚不和谐夫妇的小型研究，并报告了21/100 PY的发病率，因此在南部非洲的CVCT效果大小的共识较少。 AIM 1将使用病毒基因组测试在CVCT之前获得感染的发病率和起源，并将量化CVCT对不一致夫妻的预防影响。 UNAID和DHS数据表明，大多数婚外接触都是与长期稳定的伴侣。与并发伴侣（CPT）的联合测试对在不一致和一致的负面夫妇中获得的艾滋病毒感染的潜在影响尚未探讨。根据RO1 MH 66767开发的CVCT程序的CPT干预措施的开发（AIM 2）。仅在CVCT与CVCT+CPT诊所中，将比较获得外部婚姻的新感染的发生率。 尽管提供咨询和免费服务，但只有10％的与HIV男性伴侣的不和谐夫妇要求男性包皮环切术（MC）。像CVCT一样，MC是本地负担得起的预防策略，必须在以后的试验中提供给参与者。辅助目标4将研究男性包皮环切术（MC）的障碍，以优化以后的试验中的道德标准。