RTI International, Women's Global Health Imperative (WGHI), San Francisco, CA.
Department of Medicine, University of California San Francisco, San Francisco, CA.
J Acquir Immune Defic Syndr. 2019 Jul 1;81(3):304-310. doi: 10.1097/QAI.0000000000002028.
In MTN-020/ASPIRE, a dapivirine vaginal ring effectiveness trial in sub-Saharan Africa, we assessed whether worries about ring use changed over time and were associated with adherence.
Participants (N = 2585) were surveyed at baseline and follow-up about worries regarding daily ring use. First, they answered a question about general worries and then responded to 15 items covering specific worries. From a nested qualitative component (N = 214), we extracted themes related to ring worries and adherence. Seven months into the trial, aggregate adherence data were shared with study sites as part of an intervention that included counseling and social support. Nonadherence was defined as dapivirine plasma levels of ≤95 pg/mL. Mixed-effect logistic regression models were used to assess changes in ring worries and nonadherence from baseline to month 3 and later.
Worry about wearing the ring decreased from 29% at baseline to 4% at month 3 (P < 0.001), while having a specific worry decreased from 47% to 16% (P < 0.001). Among those enrolled before intervention, 29% with baseline worries were nonadherent at month 3 (95% confidence interval: 19% to 39%) compared to 14% without worries (95% confidence interval: 9% to 19%; P = 0.005); the difference persisted through month 6. There was no difference in nonadherence by baseline worry for those enrolled after intervention (P = 0.40). In the qualitative subset, initial ring anxieties reportedly subsided with self-experimentation and practice and the beneficial influence of the intervention.
Although worries may be an initial deterrent to correct ring use, intervening early by leveraging social influences from peers and clinicians should facilitate successful adoption and correct ring use.
在 MTN-020/ASPIRE 中,一项在撒哈拉以南非洲进行的 dapivirine 阴道环有效性试验中,我们评估了对环使用的担忧是否会随时间而变化,以及它们是否与依从性相关。
在基线和随访时,参与者(N=2585)接受了关于每日环使用担忧的调查。首先,他们回答了一个关于一般担忧的问题,然后回答了 15 个涵盖特定担忧的问题。从嵌套的定性部分(N=214)中,我们提取了与环担忧和依从性相关的主题。在试验进行到七个月时,将聚合的依从性数据作为包括咨询和社会支持在内的干预措施的一部分分发给研究地点。不依从被定义为 dapivirine 血浆水平≤95 pg/mL。使用混合效应逻辑回归模型评估从基线到第 3 个月以及之后的环担忧和不依从的变化。
从基线时的 29%到第 3 个月时的 4%(P <0.001),对佩戴环的担忧减少,而特定的担忧从 47%下降到 16%(P <0.001)。在干预前入组的人中,29%有基线担忧的人在第 3 个月时不依从(95%置信区间:19%至 39%),而没有担忧的人占 14%(95%置信区间:9%至 19%;P=0.005);这种差异一直持续到第 6 个月。对于干预后入组的人,基线担忧与不依从之间没有差异(P=0.40)。在定性部分中,据报道,通过自我试验和实践以及干预的有益影响,最初的环焦虑感逐渐减轻。
尽管担忧可能是正确使用环的最初障碍,但通过利用来自同伴和临床医生的社会影响及早干预,应该有助于成功采用和正确使用环。