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一项多国艾滋病预防试验中的预防误区与风险行为

Preventive Misconception and Risk Behaviors in a Multinational HIV Prevention Trial.

作者信息

Sugarman Jeremy, Lin Li, Baeten Jared M, Palanee-Phillips Thesla, Brown Elizabeth R, Matovu Kiweewa Flavia, Mgodi Nyaradzo M, Nair Gonasagrie, Siva Samantha, Seils Damon M, Weinfurt Kevin P

机构信息

a Berman Institute of Bioethics and Department of Medicine , Johns Hopkins University , Baltimore , Maryland , USA.

b Department of Population Health Sciences , Duke University School of Medicine , Durham , North Carolina , USA.

出版信息

AJOB Empir Bioeth. 2019 Apr-Jun;10(2):79-87. doi: 10.1080/23294515.2019.1593257. Epub 2019 Apr 19.

Abstract

BACKGROUND

Some HIV prevention research participants may hold a "preventive misconception" (PM), an overestimate of the probability or level of personal protection afforded by trial participation. However, these reports typically rely upon small, retrospective qualitative assessments that did not use a standardized approach.

METHODS

We administered a measure of PM called PREMIS, during Microbicide Trials Network 020-A Study to Prevent Infection with a Ring for Extended Use, a large, multicenter, placebo-controlled, phase III trial evaluating the safety and efficacy of a dapivirine vaginal ring among women at risk for HIV infection in Malawi, South Africa, Uganda, and Zimbabwe. The maximum follow-up period was 2.6 years.

RESULTS

One thousand two hundred sixty-one respondents completed PREMIS at their month 3 visit (M3); 2085 at their month 12 visit (M12); and 1010 at both visits. Most participants expressed high expectations of personal benefit (EPB) and that at least one of the rings used in the trial would reduce the risk of getting HIV (expectation of maximum aggregate benefit or EMAB). There was a moderate positive correlation between EPB and EMAB at M3 (r = .43, 95% CI: .37, .47) and M12 (r = .44, 95% CI: .40, .48). However, there was variability among sites in the strength of the relationship. There was no relationship between either expectation variable and condom use, adherence, or HIV infection.

CONCLUSIONS

A majority of trial participants expressed some belief that their risk of HIV infection would be reduced by using a vaginal ring, which may signal PM. However, such beliefs were not associated with adherence, condom use, or subsequent HIV infection, and there was variability across sites. Further work is needed to understand these findings.

摘要

背景

一些艾滋病预防研究参与者可能存在“预防误解”(PM),即高估了参与试验所能提供的个人保护概率或水平。然而,这些报告通常依赖于小型的回顾性定性评估,且未采用标准化方法。

方法

在杀微生物剂试验网络020-A研究(一项预防长期使用环状物感染的研究)中,我们采用了一种名为PREMIS的预防误解测量方法。该研究是一项大型、多中心、安慰剂对照的III期试验,在马拉维、南非、乌干达和津巴布韦评估感染艾滋病毒风险的女性中,评估达匹韦林阴道环的安全性和有效性。最长随访期为2.6年。

结果

1261名受访者在第3个月访视(M3)时完成了PREMIS;2085名在第12个月访视(M12)时完成;1010名在两次访视时均完成。大多数参与者对个人受益(EPB)表达了很高的期望,并且认为试验中使用的至少一种环状物会降低感染艾滋病毒的风险(最大总体受益期望或EMAB)。在M3时,EPB与EMAB之间存在中度正相关(r = 0.43,95% CI:0.37,0.47),在M12时也存在中度正相关(r = 0.44,95% CI:0.40,0.48)。然而,各研究地点之间这种关系的强度存在差异。两个期望变量与避孕套使用、依从性或艾滋病毒感染之间均无关联。

结论

大多数试验参与者表示,他们认为使用阴道环会降低感染艾滋病毒的风险,这可能表明存在预防误解。然而,这些信念与依从性、避孕套使用或随后的艾滋病毒感染无关,且各研究地点之间存在差异。需要进一步开展工作来理解这些发现。

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