Facilitators of adherence to the study pill in the FEM-PrEP clinical trial.

Facilitators of adherence to the study pill in the FEM-PrEP clinical trial.
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在FEM-PREP临床试验中坚持研究丸的促进者。

DOI:
10.1371/journal.pone.0125458
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发表时间:
2015
期刊:
影响因子:
3.7
通讯作者:
Van Damme L
Van Damme L
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Corneli A;Perry B;Agot K;Ahmed K;Malamatsho F;Van Damme L

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由于研究药物依从性较低,FEM-PrEP 并未显示出 HIV 感染率的减少。然而,血浆和细胞内药物浓度表明,一些参与者有最近服用药物的证据。我们进行了一项后续研究,以确定参与者服用研究药物的原因等。对 88 名 FEM-PrEP 参与者进行了定性半结构化访谈 (SSI)。根据 FEM-PrEP 期间收集的依从性药物浓度,有目的地选择参与者,并将其分为三个依从性访谈组:“高”、“中”和“无/稀缺”。高和中等组的参与者描述了他们大部分或部分时间坚持的原因,包括促进他们坚持的因素。所有小组的参与者都描述了他们认为其他 FEM-PrEP 参与者能够坚持的原因。此外,224 名 FEM-PrEP 参与者通过定量音频计算机辅助自我访谈 (ACASI) 报告了服用研究药物的原因。主题分析和描述性统计分别用于分析定性和定量数据。从 SSI 中确定了五个主题作为促进依从性的因素:1)参与者对研究的支持,2)降低艾滋病毒风险,3)常规工具的形成和使用,4)依从性咨询,以及 5)合作伙伴的意识和支持。当参与者谈到其他参与者的依从性时,他们描述了类似的促进者。在 ACASI 报告他们服用了研究药物的 172 名参与者中,想要帮助回答研究问题是服用药物最常见的原因 (94%,n = 161)。我们还发现了预防性误解的证据。个人动机(例如降低风险和对研究结果的兴趣)以及由外部提示、提醒和支持组成的坚持策略促进了坚持。这些发现可以为未来的艾滋病毒预防临床试验以及针对女性推出有效的基于抗逆转录病毒的艾滋病毒预防技术提供信息。
FEM-PrEP did not demonstrate a reduction in HIV acquisition because of low study pill adherence. Yet, plasma and intracellular drug concentrations indicated that some participants had evidence of recent pill use. We conducted a follow-up study to identify, among other topics, participants’ reasons for taking the study pill. Qualitative, semi-structured interviews (SSIs) were conducted with 88 FEM-PrEP participants. Participants were purposefully selected based on their adherence drug concentrations collected during FEM-PrEP and placed into three adherence interview groups: “high,” “moderate,” and “none/scarce.” Participants in the high and moderate groups described reasons why they adhered most or some of the time, including factors that facilitated their adherence. Participants in all groups described what they believed made it possible for other FEM-PrEP participants to adhere. In addition, 224 FEM-PrEP participants reported on their reasons for taking the study pills through a quantitative, audio computer-assisted self-interview (ACASI). Thematic analysis and descriptive statistics were used to analyze the qualitative and quantitative data, respectively. Five themes were identified from the SSIs as facilitating factors of adherence: 1) participants’ support for the research, 2) HIV risk reduction, 3) routine formation and use of tools, 4) adherence counseling, and 5) partner awareness and support. Participants described similar facilitators when they spoke about other participants’ adherence. Among the 172 participants who reported in ACASI that they had taken a study pill, wanting to help answer the research question was the most frequently stated reason for taking the pills (94%, n = 161). We also found evidence of preventive misconception. Adherence was facilitated by personal motivations, such as risk reduction and interest in the research outcome, and by adherence strategies consisting of external cues, reminders, and support. These findings can inform future HIV prevention clinical trials and the rollout of effective antiretroviral-based HIV prevention technologies for women.
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