Rosen Rochelle K, Morrow Kathleen M, Carballo-Diéguez Alex, Mantell Joanne E, Hoffman Susie, Gai Fang, Maslankowski Lisa, El-Sadr Wafaa M, Mayer Kenneth H
The Miriam Hospital, Providence, Rhode Island 02903, USA.
J Womens Health (Larchmt). 2008 Apr;17(3):383-92. doi: 10.1089/jwh.2006.0325.
In this phase I safety trial of tenofovir gel, a candidate vaginal microbicide for human immunodeficiency virus (HIV) prevention, a mixed-methods design was used to gather acceptability data among women participants. The impact of acceptability factors on use of the gel and the relationship between qualitative and quantitative acceptability data are explored.
Participants included low-risk, HIV-uninfected, and clinically stable HIV-infected women. Participants were enrolled into cohorts stratified by HIV serostatus, sexual activity, gel concentration, and frequency of use. Quantitative data were collected via interviewer-administered structured questionnaires. Qualitative data were collected via semistructured small group discussions.
Although 94% of participants stated they would "probably" or "definitely" use tenofovir gel, a range of responses emerged on multiple domains relevant to microbicide acceptability during the qualitative discussions. Lubrication, leakage, sexual pleasure, and the possibility of covert use were central to women's qualitative assessments of tenofovir gel.
Quantitative results indicate that tenofovir vaginal gel was acceptable to almost all users, while qualitative findings indicate that acceptability is complex, varies among users, and is likely shaped by a variety of contextual factors that manufacturers will need to consider to optimize use-effectiveness. Because of the differences in the qualitative and quantitative responses, the authors argue that future trials of candidate microbicides should include strategic collection of mixed-methods microbicide acceptability data.
在替诺福韦凝胶的I期安全性试验中，该凝胶是一种用于预防人类免疫缺陷病毒（HIV）的候选阴道杀菌剂，采用了混合方法设计来收集女性参与者的可接受性数据。探讨了可接受性因素对凝胶使用的影响以及定性和定量可接受性数据之间的关系。
参与者包括低风险、未感染HIV且临床稳定的HIV感染女性。参与者按HIV血清学状态、性活动、凝胶浓度和使用频率分层纳入队列。定量数据通过访员管理的结构化问卷收集。定性数据通过半结构化小组讨论收集。
尽管94%的参与者表示他们“可能”或“肯定”会使用替诺福韦凝胶，但在定性讨论中，在与杀菌剂可接受性相关的多个领域出现了一系列不同的反应。润滑、渗漏、性快感以及秘密使用的可能性是女性对替诺福韦凝胶定性评估的核心。
定量结果表明替诺福韦阴道凝胶几乎为所有使用者所接受，而定性结果表明可接受性很复杂，使用者之间存在差异，并且可能受到多种背景因素的影响，制造商需要考虑这些因素以优化使用效果。由于定性和定量反应存在差异，作者认为未来候选杀菌剂试验应包括策略性地收集混合方法的杀菌剂可接受性数据。
