Africa Centre for Health and Population Studies, University of KwaZulu-Natal, South Africa.
PLoS One. 2011 Jan 21;6(1):e14577. doi: 10.1371/journal.pone.0014577.
The Microbicides Development Programme evaluated the safety and effectiveness of 0.5% and 2% PRO2000/5 microbicide gels in reducing the risk of vaginally acquired HIV. In February 2008 the Independent Data Monitoring Committee recommended that evaluation of 2% PRO2000/5 gel be discontinued due to futility. The Africa Centre site systematically collected participant responses to this discontinuation.
Clinic and field staff completed field reports using ethnographic participant observation techniques. In-depth-interviews and focus group discussions were conducted with participants discontinued from 2% gel. A total of 72 field reports, 12 in-depth-interviews and 3 focus groups with 250 women were completed for this analysis. Retention of discontinued participants was also analysed. Qualitative data was analysed using NVivo 2 and quantitative data using STATA 10.0.
Participants responded initially with fear that discontinuation was due to harm, followed by acceptance after effective messaging, and finally with disappointment. Participants reported that their initial fear was exacerbated by being contacted and advised to visit the clinic for information about the closure. Operational changes were subsequently made to the contact procedures. By incorporating feedback from participants, messages were continuously revised to ensure that information was comprehensible and misconceptions were addressed quickly thereby enabling participants to accept the discontinuation. Participants were disappointed that 2% PRO2000/5 was being excluded as a HIV prevention option, but also that they would no longer have access to gel that improved their sexual relationships with their partners and assisted condom negotiations. In total 238 women were discontinued from gel and 185 (78%) went on to complete their scheduled follow-up period.
The use of qualitative social science techniques allowed the site team to amend operational procedures and messaging throughout the discontinuation period. This proved instrumental in ensuring that the discontinuation was successfully completed in a manner that was both understandable and acceptable to participants.
Current Controlled Trials. ISRCTN64716212.
微物杀菌剂开发计划评估了 0.5%和 2% PRO2000/5 杀菌剂凝胶在降低阴道获得性 HIV 风险方面的安全性和有效性。2008 年 2 月，独立数据监测委员会建议因无效而停止对 2%PRO2000/5 凝胶的评估。非洲中心站点系统地收集了参与者对这一停药的反应。
诊所和现场工作人员使用人种学参与者观察技术完成现场报告。对从 2%凝胶中停药的参与者进行了深入访谈和焦点小组讨论。共完成了 72 份现场报告、12 次深入访谈和 3 次焦点小组，共有 250 名女性参与了这项分析。还分析了停药参与者的保留情况。使用 NVivo 2 对定性数据进行分析，使用 STATA 10.0 对定量数据进行分析。
参与者最初的反应是担心停药是因为有害，然后在有效信息传递后接受，最后是失望。参与者报告说，他们最初的恐惧因被联系并被建议到诊所了解关闭信息而加剧。随后对联系程序进行了操作更改。通过纳入参与者的反馈，信息不断进行修订，以确保信息易于理解，并且能够迅速解决误解，从而使参与者能够接受停药。参与者对 2%PRO2000/5 被排除作为 HIV 预防选择感到失望，但也对他们不再能够获得改善与伴侣性关系和协助避孕套谈判的凝胶感到失望。共有 238 名女性停止使用凝胶，其中 185 名（78%）继续完成了预定的随访期。
定性社会科学技术的使用使现场团队能够在整个停药期间修改操作程序和信息传递。这对于确保以参与者能够理解和接受的方式成功完成停药至关重要。
当前对照试验。ISRCTN64716212。
