Dyadic-Based Diagnosis, Care, & Prevention for HIV Discordant Couples in Tanzania

 描述(由申请人提供)：尽管撒哈拉以南非洲20年来作出了相当大的艾滋病毒预防努力，但这一流行病继续产生破坏性影响。该区域艾滋病治疗和护理的扩大提供了重要的挽救生命的服务，但也增加了预防和护理工作中的协调和服务提供的复杂性。如何最好地结合干预策略(预防、治疗、护理、行为、生物医学)是该领域的一个紧迫问题。我们认为，结合干预措施的最佳方式是基于协同作用，干预措施的组成部分直接相互加强，而不仅仅是方案是否同时进行。此外，需求巨大，服务有限。为了最大限度地减少艾滋病毒发病率，最有可能传播和感染艾滋病毒的人必须得到更密集的干预措施。我们建议对坦桑尼亚基萨拉韦的1700对18-45岁的夫妇进行前瞻性观察研究，他们将获得以下干预措施：(1)家庭提供艾滋病毒自我检测试剂盒和检测前咨询；(2)为检测呈阳性的夫妇提供咨询和转诊中心；(3)促进登记，为确诊感染艾滋病毒的夫妇提供护理和治疗；以及(4)为艾滋病毒血清不一致夫妇的阴性伴侣提供暴露前预防措施。将对所有1700对夫妇(3400人)进行为期18个月的基线调查，并在18个月时进行艾滋病毒检测。作为双胞胎从事护理的阳性伴侣将在18个月时进行CD4和病毒负载测试。所有通过自我检测和进入护理的艾滋病毒血清不一致夫妇(估计为50对夫妇)也将接受额外的6个月和12个月的调查，我们将收集每一次诊所就诊的持续临床数据。将在注册时收集生物特征数据(指纹)，并收集与咨询和转诊中心以及艾滋病毒治疗中心的所有接触，以便将服务利用情况与调查数据联系起来。这个 研究将定位该项目，如果发现令人信服的疗效，并建立安全性和接受性，则将推进到适当功率的随机对照试验。

 DESCRIPTION (provided by applicant): Despite 20 years of considerable HIV prevention efforts in Sub Saharan Africa the epidemic continues to have devastating impacts. The advent of expansion of treatment and care for AIDS in the region has provided important and lifesaving services, but has also added complexity to coordination and service delivery across prevention and care efforts. How to best combine intervention strategies (prevention, treatment, care, behavioral, biomedical) is a pressing question in the field. We believe that the best way to combine interventions is based on synergy, with intervention components directly reinforcing one another, not just whether programs occur simultaneously. In addition, needs are great and services limited. To achieve the maximum population-level reduction in HIV incidence it is important that those at greatest risk of transmitting and acquiring HIV receive more intensive interventions. We propose to conduct a prospective observational study of 1700 couples aged 18-45 years in Kisarawe, Tanzania who will be provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling provided at the household, (2) linkage to a counseling and referral center for those who test positive, (3) facilitated enrollment to care and treatment for couples with confirmed HIV infection; and (4) access to pre-exposure prophylaxis for the negative partner in a HIV sero-discordant couple. A baseline and 18- month survey will be administered to all 1700 couples (3400 individuals), with a HIV and test conducted at 18-months. Positive partners who engaged in care as a dyad will have a CD4 and viral load test conducted at 18 months. All HIV sero-discordant couples identified through self-testing and entering care (estimated to be 50 couples) will also be administered an additional 6- and 12-month survey, and we will collect ongoing clinical data from each clinic visit. Biometric data (fingerprint) will be collected at enrollment, and all encounters with the counseling and referral center, and HIV treatment center, to allow linking of utilization of services with survey data. The study will position the project to advance to an appropriately powered randomized controlled trial should compelling efficacy be found, and safety and acceptance be established.