Kibuuka Hannah, Guwatudde David, Kimutai Robert, Maganga Lucas, Maboko Leonard, Watyema Cecilia, Sawe Fredrick, Shaffer Douglas, Matsiko Dickson, Millard Monica, Michael Nelson, Wabwire-Mangen Fred, Robb Merlin
Makerere University-Walter Reed Project, Kampala, Uganda.
PLoS One. 2009;4(4):e5164. doi: 10.1371/journal.pone.0005164. Epub 2009 Apr 10.
HIV vaccine trials generally require that pregnant women are excluded from participation, and contraceptive methods must be used to prevent pregnancy during the trial. However, access to quality services and misconceptions associated with contraceptive methods may impact on their effective use in developing countries. We describe the pattern of contraceptive use in a multi-site phase I/IIa HIV Vaccine trial in East Africa (Uganda, Kenya and Tanzania) and factors that may have influenced their use during the trial.
Pregnancy prevention counseling was provided to female participants during informed consent process and at each study visit. Participants' methods of contraception used were documented. Methods of contraceptives were provided on site. Pregnancy testing was done at designated visits during the trial. Obstacles to contraceptive use were identified and addressed at each visit.
Overall, 103 (31.8%) of a total of 324 enrolled volunteers were females. Female participants were generally young with a mean age of 29(+/-7.2), married (49.5%) and had less than high school education (62.1%). Hormonal contraceptives were the most common method of contraception (58.3%) followed by condom use (22.3%). The distribution of methods of contraception among the three sites was similar except for more condom use and less abstinence in Uganda. The majority of women (85.4%) reported to contraceptive use prior to screening. The reasons for not using contraception included access to quality services, insufficient knowledge of certain methods, and misconceptions.
Although hormonal contraceptives were frequently used by females participating in the vaccine trial, misconceptions and their incorrect use might have led to inconsistent use resulting in undesired pregnancies. The study underscores the need for an integrated approach to pregnancy prevention counseling during HIV vaccine trials.
ClinicalTrials.gov NCT00123968.
HIV疫苗试验通常要求将孕妇排除在参与范围之外，并且在试验期间必须采用避孕方法来防止怀孕。然而，在发展中国家，获得优质服务以及与避孕方法相关的误解可能会影响这些方法的有效使用。我们描述了东非（乌干达、肯尼亚和坦桑尼亚）一项多中心I/IIa期HIV疫苗试验中避孕方法的使用模式以及在试验期间可能影响其使用的因素。
在知情同意过程中以及每次研究访视时，向女性参与者提供预防怀孕咨询。记录参与者使用的避孕方法。在现场提供避孕方法。在试验期间的指定访视时进行妊娠检测。在每次访视时识别并解决避孕使用的障碍。
总体而言，在总共324名登记的志愿者中，有103名（31.8%）为女性。女性参与者一般较为年轻，平均年龄为29岁（±7.2岁），已婚（49.5%），且受教育程度低于高中（62.1%）。激素避孕是最常用的避孕方法（58.3%），其次是使用避孕套（22.3%）。除了乌干达使用避孕套的比例较高且禁欲比例较低外，三个地点的避孕方法分布相似。大多数女性（85.4%）报告在筛查前就已使用避孕方法。不使用避孕方法的原因包括难以获得优质服务、对某些方法了解不足以及存在误解。
尽管参与疫苗试验的女性经常使用激素避孕方法，但误解及其不正确的使用可能导致使用不规律，从而导致意外怀孕。该研究强调了在HIV疫苗试验期间需要采用综合方法进行预防怀孕咨询。
ClinicalTrials.gov NCT00123968
