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阳伞协议:缅甸男同性恋者和跨性别女性艾滋病毒连续护理干预措施的实施科学研究。

The Parasol Protocol: An Implementation Science Study of HIV Continuum of Care Interventions for Gay Men and Transgender Women in Burma/Myanmar.

作者信息

Wirtz Andrea L, Naing Soe, Clouse Emily, Thu Kaung Htet, Mon Sandra Hsu Hnin, Tun Zin Min, Baral Stefan, Paing Aung Zayar, Beyrer Chris

机构信息

Center for Public Health and Human Rights, Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.

International HIV/AIDS Alliance in Myanmar, Yangon, Myanmar.

出版信息

JMIR Res Protoc. 2017 May 17;6(5):e90. doi: 10.2196/resprot.7642.

Abstract

BACKGROUND

Efforts to improve HIV diagnosis and antiretroviral therapy (ART) initiation among people living with HIV and reduce onward transmission of HIV rely on innovative interventions along multiple steps of the HIV care continuum. These innovative methods are particularly important for key populations, including men who have sex with men (MSM) and transgender women (TW). The HIV epidemic in Myanmar is concentrated among key populations, and national efforts now focus on reducing stigma and improving engagement of MSM and TW in HIV prevention and care.

OBJECTIVE

This study aims to test the use of several innovations to address losses in the HIV care continuum: (1) use of respondent-driven sampling (RDS) to reach and engage MSM and TW in HIV testing, (2) HIV self-testing (HIVST) to increase HIV testing uptake and aid early diagnosis of infection, (3) community-based CD4 point-of-care (POC) technology to rapidly stage HIV disease for those who are HIV infected, and (4) peer navigation support to increase successful health system navigation for HIV-infected MSM and TW in need of ART or HIV engagement in care.

METHODS

To assess the effect of HIVST, we will implement a randomized trial in which MSM and TW adults in the greater Yangon metropolitan area who are HIV uninfected will be recruited via RDS (N=366). Participants will complete a baseline socio-behavioral survey and will be randomized to standard, voluntary counseling and testing (VCT) or to HIVST. Biologic specimens will be collected during this baseline visit for confirmatory testing using dried blood spots. Participants will be asked to return to the study office to complete a second study visit in which they will report their HIV test result and answer questions on the acceptability of the assigned testing method. Aim 1 participants with confirmed HIV infection and who are not engaged in care (N=49) will be offered direct enrollment into Aims 2 and 3, which include immediate CD4 POC and the option for peer navigation, respectively. Aims 2 and 3 participants will be prospectively followed for 12 months with data collection including interviewer-administered sociobehavioral survey, CD4 POC, and viral load testing occurring biannually. Participants who accept peer navigation will be compared to those who decline peer navigation. Analyses will estimate the impact of CD4 POC on engagement in care and the impact of peer navigation on ART adherence and viral load.

RESULTS

Formative qualitative research was conducted in June and September 2015 and led to further refinement of recruitment methods, HIVST instructions and counseling, and peer navigation methods. Aim 1 recruitment began in November 2015 with subsequent enrollment into Aims 2 and 3 and is currently ongoing.

CONCLUSIONS

These innovative interventions may resolve gaps in the HIV care continuum among MSM and TW and future implementation may aid in curbing the HIV epidemic among MSM and TW in Myanmar.

摘要

背景

为改善艾滋病毒感染者的艾滋病毒诊断和抗逆转录病毒治疗(ART)启动情况,并减少艾滋病毒的进一步传播,需要在艾滋病毒护理连续过程的多个环节采取创新干预措施。这些创新方法对包括男男性行为者(MSM)和跨性别女性(TW)在内的关键人群尤为重要。缅甸的艾滋病毒疫情集中在关键人群中,目前国家的努力重点是减少耻辱感,并提高男男性行为者和跨性别女性对艾滋病毒预防和护理的参与度。

目的

本研究旨在测试几种创新方法,以解决艾滋病毒护理连续过程中的缺失环节:(1)使用应答驱动抽样(RDS)来接触男男性行为者和跨性别女性并促使其参与艾滋病毒检测;(2)艾滋病毒自我检测(HIVST)以提高艾滋病毒检测率并有助于早期感染诊断;(3)基于社区的CD4即时检测(POC)技术,为艾滋病毒感染者快速确定疾病阶段;(4)同伴导航支持,以增加需要抗逆转录病毒治疗或参与艾滋病毒护理的艾滋病毒感染男男性行为者和跨性别女性成功进入卫生系统的机会。

方法

为评估艾滋病毒自我检测的效果,我们将开展一项随机试验,通过应答驱动抽样招募仰光大都市区未感染艾滋病毒的成年男男性行为者和跨性别女性(N = 366)。参与者将完成基线社会行为调查,并被随机分为接受标准自愿咨询检测(VCT)或艾滋病毒自我检测。在此基线访视期间将采集生物样本,使用干血斑进行确证检测。参与者将被要求返回研究办公室完成第二次研究访视,报告其艾滋病毒检测结果,并回答有关指定检测方法可接受性的问题。目标1中确诊感染艾滋病毒且未接受护理的参与者(N = 49)将被直接纳入目标2和目标3,目标2包括即时CD4即时检测,目标3包括同伴导航选项。目标2和目标3的参与者将被前瞻性随访1年,数据收集包括访谈员实施的社会行为调查、CD4即时检测和每半年进行一次的病毒载量检测。接受同伴导航的参与者将与拒绝同伴导航的参与者进行比较。分析将估计CD4即时检测对护理参与度的影响以及同伴导航对ART依从性和病毒载量的影响。

结果

2015年6月和9月进行了形成性定性研究,进一步完善了招募方法、艾滋病毒自我检测说明和咨询以及同伴导航方法。目标1的招募于2015年11月开始,随后纳入目标2和目标3,目前仍在进行中。

结论

这些创新干预措施可能解决男男性行为者和跨性别女性在艾滋病毒护理连续过程中的差距,未来的实施可能有助于遏制缅甸男男性行为者和跨性别女性中的艾滋病毒疫情。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77da/5451637/d9b8209a8ec5/resprot_v6i5e90_fig1.jpg

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