在中国男男性行为者中开展HIV自我检测以促进血清学状态披露：阶梯楔形随机对照试验方案

HIV Self-Testing to Promote Serostatus Disclosure Among Men Who Have Sex With Men in China: Protocol for a Stepped Wedge Randomized Controlled Trial.

作者信息

Lu Tianyi, Li Hang, Mao Xiang, Peng Erlei, Gao Yangyang, Chu Zhenxing, Zhang Jing, Dong Willa, Jiang Yongjun, Xu Junjie

机构信息

NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.

Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.

出版信息

JMIR Res Protoc. 2020 Jul 9;9(7):e17788. doi: 10.2196/17788.

DOI:10.2196/17788

PMID:32673264

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7380896/

Abstract

BACKGROUND

Disclosure of HIV serostatus is important for the prevention of HIV infection among men who have sex with men (MSM). However, knowledge of sexual partners' HIV status among MSM in China is low. As a complement to HIV testing services, HIV self-testing (HIVST) has considerable potential to promote serostatus disclosure.

OBJECTIVE

The primary objective of our trial is to evaluate the effect of HIVST on improving serostatus disclosure to sexual partners. We hypothesize that MSM in an intervention condition will have a higher awareness of the HIV status of their sexual partners compared with MSM in the control condition. The secondary aims are to evaluate (i) changes in sexual behaviors after disclosure of HIV status by sexual partners, (ii) promotion of the frequency of HIV and syphilis testing on participants and their sexual partners, and (iii) factors that restrict the disclosure of HIV infection to sexual partners. We hypothesize that MSM in the intervention condition will exhibit safer sexual decision making and a higher rate of HIV testing uptake compared with MSM in the control condition.

METHODS

A stepped wedge randomized controlled trial will be conducted throughout China. Study recruitment of 800 MSM will be promoted through advertisements released on WeChat public accounts. Individuals who are born biologically male, aged ≥18 years, HIV negative, and who have not undergone HIV testing in the past 3 months will be recruited. Eligible men will be randomly divided (1:1:1:1) into four groups and randomized. The group cluster will initiate the intervention so that participants will be provided with 2-4 free finger prick-based HIVST kits until trial completion. The intervention period for participants in each of the four groups will be initiated at 3-month intervals. Men in both groups will be required to complete a baseline and four follow-up surveys every 3 months. The primary intervention outcome will evaluate the effect of the distribution of HIVST kits on improvement in the disclosure of sexual partners' HIV status. The secondary outcomes will be changes in sexual behaviors after disclosure of HIV status from sexual partners, the promotion of the frequency of HIVST on participants and their sexual partners, and the factors that restrict disclosure of HIV status to sexual partners.

RESULTS

Subject recruitment began in August 2018. The first round of follow-up surveys post intervention is complete, with three rounds remaining to be done. Data analysis was scheduled for April 2020 and the results will be disseminated through conferences and peer-reviewed publications.

CONCLUSIONS

Few studies have evaluated interventions to increase knowledge of sexual partners' HIV status among MSM. Our trial will provide information on the link between HIVST and HIV serostatus disclosure. The findings of this trial will facilitate the implementation of HIVST services to help control the spread of HIV among MSM in China.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR1800019453; http://www.chictr.org.cn/showproj.aspx?proj=30158.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17788.

摘要

背景

披露艾滋病毒血清学状态对于预防男男性行为者（MSM）中的艾滋病毒感染至关重要。然而，中国男男性行为者对性伴侣艾滋病毒感染状况的知晓率较低。作为艾滋病毒检测服务的补充，艾滋病毒自我检测（HIVST）在促进血清学状态披露方面具有相当大的潜力。

目的

我们试验的主要目的是评估艾滋病毒自我检测对提高向性伴侣披露血清学状态的效果。我们假设，与对照组的男男性行为者相比，处于干预组的男男性行为者对其性伴侣的艾滋病毒感染状况有更高的知晓率。次要目标是评估：（i）性伴侣披露艾滋病毒感染状况后性行为的变化；（ii）促进参与者及其性伴侣进行艾滋病毒和梅毒检测的频率；（iii）限制向性伴侣披露艾滋病毒感染状况的因素。我们假设，与对照组的男男性行为者相比，处于干预组的男男性行为者将表现出更安全的性决策，并具有更高的艾滋病毒检测接受率。

方法

将在中国各地开展一项阶梯式楔形随机对照试验。将通过微信公众号发布的广告来促进招募800名男男性行为者参与研究。招募对象为生物学上为男性、年龄≥18岁、艾滋病毒检测阴性且在过去3个月内未进行过艾滋病毒检测的个体。符合条件的男性将被随机分为（1:1:1:1）四组并进行随机分组。群组将启动干预措施，以便为参与者提供2 - 4个基于手指针刺的免费艾滋病毒自我检测试剂盒，直至试验完成。四组参与者的干预期将每隔3个月启动一次。两组男性都将被要求每3个月完成一次基线调查和四次随访调查。主要干预结果将评估艾滋病毒自我检测试剂盒的发放对改善性伴侣艾滋病毒感染状况披露的效果。次要结果将是性伴侣披露艾滋病毒感染状况后性行为的变化、促进参与者及其性伴侣进行艾滋病毒自我检测的频率，以及限制向性伴侣披露艾滋病毒感染状况的因素。