HIV/HAART and Pregnancy/Contraception in Rakai, Uganda

描述（由申请人提供）：据估计，到2007年底，撒哈拉以南非洲有1 300多万妇女感染了艾滋病毒/艾滋病。本研究的目的是在乌干达Rakai的抗逆转录病毒治疗可及性和个人和夫妇使用情况下，评估艾滋病毒感染、生育结果和避孕药具使用之间的相互作用。根据建议的RO1，我们计划分析自1994年以来每年接受调查的约12,000名Rakai社区队列调查（RCCS）参与者样本收集的数据。我们的具体目标是评估：(i)避孕药具使用的决定因素以及生育意愿和意图对避孕药具使用和怀孕率的影响，（ii）激素避孕药具对艾滋病毒疾病进展的影响，以及抗逆转录病毒疗法对生育结果、避孕药具使用和高风险行为的影响，以及（iii）艾滋病毒一致和血清不一致夫妇的生育结果和避孕药具使用。避孕药具使用率、怀孕率和流产率将通过年度调查和使用泊松回归估计的比率进行评估。对数二项回归方法将用于评估避孕药具使用的决定因素。生存分析和Kaplan-Meier生存曲线将用于评估激素避孕药对HIV进展指标的影响（从感染到死亡的时间、到艾滋病的时间、到CD4 <250/mm3的时间、CD4下降、病毒设定点和临床症状）。比例比率模型将用于估计妇女在使用抗逆转录病毒治疗前后怀孕频率和妊娠损失的变化。为了解释个体内的重复测量，我们将对连续变量使用随机效应模型，对具有稳健方差的GEE估计的二元结果使用马尔可夫和随机效应逻辑回归。RCCS提供关于艾滋病毒状况、社会人口、行为和健康特征的独特的纵向、基于社区的数据。目前迫切需要关于感染艾滋病毒妇女的有效、长期避孕药具以及艾滋病毒治疗对生育结果、避孕药具使用和高风险行为的影响的数据。至关重要的是，在艾滋病毒感染和抗逆转录病毒治疗的提供和使用的背景下，更好地了解影响生殖健康结果和避孕药具使用的因素，以便为政策和方案提供信息，指导个人和夫妇在性健康和生育方面做出更安全的决定。公共卫生相关性：乌干达的总生育率非常高（6.7%），避孕药具使用率很低（15.6%），未满足的需求很高（35%），因此迫切需要了解影响艾滋病毒预防、避孕药具使用和妊娠结局决策的因素，以及这些因素在多大程度上受到抗逆转录病毒疗法的提供和使用的影响。RCCS有数据来回答这些紧迫的公共卫生问题，包括艾滋病毒感染者和艾滋病毒感染者和夫妇之间的避孕选择和生育结果。

DESCRIPTION (provided by applicant): Over 13 million women in sub-Saharan Africa were estimated to be infected with HIV/AIDS by end of 2007. The goal of this study is to assess the interactions between HIV infection, fertility outcomes and contraceptive use in the context ART availability and use among individuals and couples in Rakai, Uganda. Under the proposed RO1, we plan to analyze data collected annually on a sample of the approximately 12,000 Rakai Community Cohort Survey (RCCS) participants surveyed annually since 1994. Our specific aims are to assess: (i) determinants of contraceptive use and impact of fertility desires and intention on contraceptive use and pregnancy rates, (ii) impact of hormonal contraceptives on HIV disease progression as well as the impact of ARTs on fertility outcomes, contraceptive use and high risk behaviors, and (iii) fertility outcomes and contraceptive use among HIV-concordant and serodiscordant couples. Rates of contraceptive use, pregnancy, and pregnancy loss will be assessed through annual surveys and rate ratios estimated using Poisson regression. Log-binomial regression methods will be used to assess determinants of contraceptive use. Survival analyses and Kaplan-Meier survival curves will be used to assess the impact of hormonal contraceptives on HIV progression indicators (time from infection to death, time-to- AIDS, time to CD4 <250/mm3, and CD4 decline, viral set point and clinical symptoms). Proportional rate models will be used to estimate the within woman change in frequency of pregnancy and pregnancy loss before and after ART use. To account for repeat measurements within individuals we will use random-effects models for continuous variables and Markovian and random-effects logistic regression for binary outcomes with GEE estimation of robust variance. The RCCS provides unique longitudinal, community based data on HIV status, sociodemographic, behavioral and health characteristics. There is an urgent need for data on effective, long-term contraceptives for HIV-infected women and impact of HIV treatment on fertility outcomes, contraceptive use and high risk behaviors. It is critical that factors influencing reproductive health outcomes and contraceptive use in the backdrop of HIV infection and ART availability and use are better understood so as to inform policy and programs to guide individuals and couples make safer decisions regarding their sexual health and child bearing. PUBLIC HEALTH RELEVANCE: With a very high total fertility rate (6.7), low levels of contraceptive use (15.6%) and high levels of unmet need (35%) in Uganda, there is a pressing need to understand factors affecting decisions regarding HIV prevention, contraceptive use and pregnancy outcomes and the extent to which these factors are modified by ART availability and use. The RCCS has data to answer these pressing public health questions regarding contraceptive choices and fertility outcomes among HIV+ and HIV- individuals and couples.