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: 8982040
• 负责人: Susan A Allen
• 金额: $ 51.18万
• 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/8982040
• 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; 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; formative assessment; 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）：在为未来的生物医学和行为干预试验做准备时，确定高危人群中的艾滋病毒发病率至关重要，这些人群已从当地提供的最佳、最实惠的预防计划中受益。四分之三的非洲成年人处于同居状态，这是大多数新感染病例发生的地方。 “同爱”运动提倡一夫一妻制，但除非性二元组中的双方——无论是已婚还是同居——都具有相同的感染状况，否则忠诚并不能起到保护作用。在该应用中，赞比亚政府诊所向同居夫妇提供的夫妇自愿艾滋病毒咨询和检测（CVCT）将扩展到同时存在的伴侣，并将衡量联合检测对同居内外感染艾滋病毒发病率的影响。 不和谐的夫妻对于艾滋病毒预防研究至关重要：它们可以研究男对女和女对男传播中“传染”和“脆弱性”的病毒学、免疫学和免疫遗传学相关性，并测试 HIV+ 和 HIV- 伴侣的生物医学和行为干预措施。比较捐赠者和接受者体内传播的病毒，阐明了疫苗必须克服的选择过程。 对中东部非洲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 HIV 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 6/100 PY，另外 1.5/100 PY 是由同时性伴侣感染的。只有一项针对未经咨询的赞比亚不和谐夫妇的小型已发表研究，报告的发生率为 21/100 PY，因此对于 CVCT 在南部非洲的影响大小尚无共识。目标 1 将使用病毒基因组测试来检查 CVCT 之前获得的感染的发生率和起源，并将量化 CVCT 对不和谐夫妇的预防影响。 联合国艾滋病规划署和国土安全部的数据表明，大多数婚外接触都是与长期稳定的伴侣发生的。尚未探讨在不一致和一致阴性夫妇中，与同时伴侣联合检测 (CPT) 对婚外艾滋病毒感染的潜在影响。在根据 RO1 MH 66767 开发的 CVCT 程序改编的 CPT 干预措施的开发（目标 2）之前，将进行形成性评估阶段。由研究团队管理的 40 个提供 CVCT 服务的诊所将被随机提供 CPT（目标 3）。将比较仅 CVCT 与 CVCT+CPT 诊所中婚外新感染的发生率。 尽管有咨询和免费服务，但只有 10% 的与艾滋病毒男性伴侣关系不睦的夫妇要求进行男性包皮环切术 (MC)。与 CVCT 一样，MC 是一种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向参与者提供。辅助目标 4 将调查男性包皮环切术 (MC) 的障碍，以在未来的试验中优化对道德标准的遵守。