GH13-006: RESEARCH AND TECHNICAL ASSISTANCE FO REPUBLIC HEALTH INT

描述（由申请人提供）： 该项目旨在通过实施四个具体研究项目，建设海地卫生部进行、解释、传播和应对评估、调查和其他评价的能力： 第一项研究将重点关注海地各种特定儿科感染的血清阳性率，并将通过招募1200名5-10岁的儿童并收集血清和DBS（干血斑）样本在国家公共卫生实验室（LNSP）进行测试，重点关注疫苗可预防的疾病，包括B肝炎（ELISA）和风疹和麻疹的IFA。分析将侧重于疾病患病率和与各种感染相关的患者特征的描述性测量。 第二项研究将重点评估肺炎球菌结合疫苗的影响， 招募大约500名0至5岁的儿童， 在太子港的国家公共卫生参考实验室，通过分离和常规血清分型方法对鼻咽标本进行检测。 第三项研究将通过两轮回顾性研究评估艾滋病毒死亡率的决定因素 和前瞻性。目标人群将是2005-2009年在15个卫生机构就诊的18岁男女艾滋病毒阳性成年人，该研究将比较接受抗逆转录病毒治疗的艾滋病毒感染者与未接受治疗的艾滋病毒感染者的生存率。 第四项研究将侧重于与标准治疗（在CD 4测定后）相比的PLHIV早期治疗。试验和治疗组的患者将在诊断后一周内接受治疗，同时接受“治疗前准备”咨询。标准治疗组将按照当前实践接受治疗（当CD 4 <350时及之后，治疗前咨询）。所有参与者将定期检测VL和未达到抑制时的耐药性（VL > 1000）。本研究的主要结局将是开始治疗后12个月的病毒载量（VL）抑制。 结果将在5年内进行衡量。

DESCRIPTION (provided by the applicant): The project aims to build the capacity of the Ministry of Health in Haiti to conduct, interpret, disseminate, and respond to assessments, surveys and other evaluations through the implementation of four specific research projects: The first study will focus on the seroprevalence of various specific pediatric infections in Haiti and will be carried out by enrolling 1200 children ages 5-10 and collecting Serum and DBS (dry blood spot) samples to be tested at the National Public Health Laboratory (LNSP) with a focus on vaccine preventable diseases including hepatitis B (ELISA) and IFA for rubella and measles. Analysis will focus on descriptive measures of disease prevalence and patient characteristics associated with various infections. The second study will focus on evaluation of the impact of pneumococcal conjugate vaccine by enrolling approximately 500 children evenly distributed from 0 to 5 years of age and collecting nasopharyngeal specimens to be tested via isolation and conventional serotyping methods at the National Public Health Reference lab in Port-au-Prince. The third study will assess the determinants of HIV mortality through two rounds, retrospective and prospective. The target population will be HIV positive adults of both sexes aged 18 years seen at 15 health institutions from 2005-2009 and the study will compare the survival of ARV-treated versus PLHIV that did not receive treatment. The fourth study will focus on early treatment of PLHIV compared to the standard of care (after CD4 determination. Patients in the test and treat arm will receive treatment within a week of diagnosis concurrent with the "pretreatment preparation" counseling. The standard of care arm will receive treatment as per current practice (when CD4 <350 and after, pretreatment counseling). All participants will be tested periodically for VL and drug resistance when suppression is not reached (VL > 1000). The primary outcome of the study will be viral load (VL) suppression at 12 months after initiation of therapy. Outcomes will be measured for a period of 5 years.