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两种基于网络和理论的干预措施,以及在中国男男性行为者中推广 HPV 疫苗接种方面有和没有简短动机访谈的干预措施:随机对照试验。

Two Web-Based and Theory-Based Interventions With and Without Brief Motivational Interviewing in the Promotion of Human Papillomavirus Vaccination Among Chinese Men Who Have Sex With Men: Randomized Controlled Trial.

机构信息

JC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.

NeoHealth, Hong Kong, China.

出版信息

J Med Internet Res. 2021 Feb 2;23(2):e21465. doi: 10.2196/21465.

Abstract

BACKGROUND

Human papillomavirus (HPV) vaccination is effective in the prevention of vaccine-type genital warts and cancers among men who have sex with men (MSM).

OBJECTIVE

The primary objective of this randomized controlled trial (RCT) is to evaluate the efficacies of 2 web- and theory-based interventions with and without brief motivational interviewing (MI) over the phone to increase the completion of HPV vaccination among unvaccinated participants within a 24-month follow-up period compared with the control group.

METHODS

A 3-arm parallel-group RCT was conducted between July 2017 and December 2019. Five telephone surveys were conducted at baseline and at 3, 6, 9, and 24 months by blinded interviewers. Participants were Hong Kong Chinese-speaking MSM aged between 18 and 45 years with regular internet access who were recruited from outreaching at venues, web-based recruitment, and peer referral. Those who had ever received HPV vaccination were excluded. A total of 624 participants were randomized into either the online tutorial (OT) only group (n=208), the OT plus MI group (OT-MI; n=208), or the control group (n=208). In total, 459 (459/624, 73.6%) completed the follow-up evaluation at 24 months. Participants in the OT group received a fully automated OT developed based on the health belief model. On top of the same OT, the OT-MI group received brief MI over the phone. Reminders were sent to the participants of the OT and OT-MI groups after 1, 2, 4, 6, and 8 months. Participants in the control group received web-based health communication messages unrelated to HPV or HPV vaccination. The research team validated the self-reported HPV vaccination uptake. Intention-to-treat analysis was used for outcome analyses. Logistic regression models and multivariable linear regression models were used to test the between-group differences in primary and secondary outcomes. Baron and Kenny's methods were used to test the mediation hypothesis.

RESULTS

The participants in the OT-MI group reported a significantly higher validated completion of HPV vaccination at 24 months than the control group (36/208, 17.3% vs 15/208, 7.2%; P=.006). However, the difference in HPV vaccination completion between the OT and the control groups (24/208, 11.5% vs 15/208, 7.2%; P=.17), or between OT-MI and OT groups (P=.13), was not statistically significant. The association between randomization status (OT-MI group vs control group) and HPV vaccination completion became statistically nonsignificant after controlling for changes in the perceived susceptibility to HPV (24 months vs baseline), whereas perceived susceptibility remained strongly associated with HPV vaccination uptake in the model (P<.001). Changes in perceived susceptibility fully mediated the intervention effect.

CONCLUSIONS

Theory-based OT with brief MI over the phone was effective in increasing HPV vaccination completion among Chinese MSM. Perceived susceptibility is an active theoretical component that causes behavioral changes.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03286907; https://clinicaltrials.gov/ct2/show/NCT03286907.

摘要

背景

人乳头瘤病毒(HPV)疫苗接种在预防男男性行为者(MSM)中与 HPV 相关的生殖器疣和癌症方面非常有效。

目的

本随机对照试验(RCT)的主要目的是评估 2 种基于网络和理论的干预措施,以及是否结合电话中的简短动机性访谈(MI),在 24 个月的随访期间,与对照组相比,增加未接种疫苗的参与者完成 HPV 疫苗接种的效果。

方法

2017 年 7 月至 2019 年 12 月进行了 3 臂平行组 RCT。在基线和 3、6、9 和 24 个月,由盲法调查员进行了 5 次电话调查。参与者为年龄在 18 至 45 岁之间、有规律上网的香港华裔 MSM,通过外展、网络招募和同伴推荐招募。那些曾经接受过 HPV 疫苗接种的人被排除在外。共有 624 名参与者被随机分配到仅在线教程(OT)组(n=208)、OT 加 MI 组(OT-MI;n=208)或对照组(n=208)。共有 459 名(459/624,73.6%)参与者在 24 个月时完成了随访评估。OT 组的参与者接受了基于健康信念模型的完全自动化的 OT。在相同的 OT 基础上,OT-MI 组接受了电话中的简短 MI。在 1、2、4、6 和 8 个月后,向 OT 和 OT-MI 组的参与者发送提醒。对照组的参与者收到了与 HPV 或 HPV 疫苗接种无关的网络健康通讯信息。研究团队验证了自我报告的 HPV 疫苗接种情况。意向治疗分析用于结果分析。逻辑回归模型和多变量线性回归模型用于检验主要和次要结局的组间差异。使用 Baron 和 Kenny 的方法检验中介假设。

结果

OT-MI 组的参与者报告称,在 24 个月时,HPV 疫苗接种的完成情况经验证明显高于对照组(36/208,17.3%比 15/208,7.2%;P=.006)。然而,OT 组和对照组(24/208,11.5%比 15/208,7.2%;P=.17)或 OT-MI 组和对照组(P=.13)之间 HPV 疫苗接种完成率的差异没有统计学意义。随机分组状态(OT-MI 组与对照组)与 HPV 疫苗接种完成之间的关联在控制 HPV 易感性变化(24 个月与基线)后变得没有统计学意义,而在模型中,感知易感性仍然与 HPV 疫苗接种率密切相关(P<.001)。感知易感性的变化完全介导了干预效果。

结论

基于理论的带有电话中简短 MI 的 OT 可有效增加华裔 MSM 中 HPV 疫苗接种的完成率。感知易感性是引起行为变化的积极理论组成部分。

试验注册

ClinicalTrials.gov NCT03286907;https://clinicaltrials.gov/ct2/show/NCT03286907。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c550/7886619/c1ed543d949a/jmir_v23i2e21465_fig1.jpg

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