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针对加拿大卡尔加里和多伦多的女同性恋、双性恋、酷儿及其他与女性发生性行为的女性群体开展的艾滋病毒和性传播感染预防干预措施:一项非随机队列试点研究的研究方案。

A group-based HIV and sexually transmitted infections prevention intervention for lesbian, bisexual, queer and other women who have sex with women in Calgary and Toronto, Canada: study protocol for a non-randomised cohort pilot study.

作者信息

Logie Carmen H, Navia Daniela, Rwigema Marie-Jolie, Tharao Wangari, Este David, Loutfy Mona R

机构信息

Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Canada.

出版信息

BMJ Open. 2014 Apr 23;4(4):e005190. doi: 10.1136/bmjopen-2014-005190.

DOI:10.1136/bmjopen-2014-005190
PMID:24760356
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4010811/
Abstract

INTRODUCTION

The limited research that exists suggests that lesbian, bisexual queer (LBQ) and other women who have sex with women are at similar risk for sexually transmitted infections (STI) as heterosexual women. However, scant research has evaluated HIV and STI prevention strategies for LBQ women. The authors present the rationale and study protocol for developing and pilot testing a psychoeducational group-based HIV and STI prevention intervention with LBQ women in Calgary and Toronto, Canada.

METHODS AND ANALYSIS

This is a multicentre non-randomised cohort pilot study. The target population is LBQ women in Calgary and Toronto, Canada. The authors aim to recruit 40 participants using purposive peer-driven recruitment methods. Participants will conduct a pretest followed by a 2-day group programme of six 2 h sessions addressing stigma, STI and HIV prevention, healthy relationships, safer sex self-efficacy, self-worth, social support and LBQ community engagement. Participants will conduct a post-test directly following the intervention and 6 weeks after the intervention. The primary outcome is safer sex practices; our prespecified index of clinically significant change is an effect size of 0.50. Secondary outcomes include: safer sex self-efficacy, STI testing frequency, STI knowledge, resilient coping, social support, sexual stigma, access to care, depression and self-esteem. We will conduct mixed-effects regression to calculate mean outcome pre-post test score change.

ETHICS AND DISSEMINATION

Research ethics approval was attained from the Office of Research Ethics (REB: 29291), University of Toronto, Toronto, Ontario, Canada. Trial results will be published according to the Transparent Reporting of Evaluations with Non-randomised Designs (TREND) statement, regardless of the outcomes.

TRIAL REGISTRATION NUMBER

This study is registered at http://clinicaltrials.gov, registration number NCT02067845.

摘要

引言

现有的有限研究表明,女同性恋、双性恋、酷儿(LBQ)及其他与女性发生性行为的女性感染性传播感染(STI)的风险与异性恋女性相似。然而,针对LBQ女性的艾滋病毒和性传播感染预防策略的研究却很少。作者介绍了在加拿大卡尔加里和多伦多为LBQ女性开发并试点测试基于心理教育小组的艾滋病毒和性传播感染预防干预措施的基本原理和研究方案。

方法与分析

这是一项多中心非随机队列试点研究。目标人群是加拿大卡尔加里和多伦多的LBQ女性。作者旨在采用有目的的同伴驱动招募方法招募40名参与者。参与者将进行预测试,然后参加为期2天的小组项目,该项目包括六个2小时的课程,内容涉及耻辱感、性传播感染和艾滋病毒预防、健康关系、安全性行为自我效能、自我价值、社会支持以及LBQ社区参与。参与者将在干预结束后立即进行后测试,并在干预后6周进行后测试。主要结果是安全性行为实践;我们预先设定的具有临床显著变化的指标是效应大小为0.50。次要结果包括:安全性行为自我效能、性传播感染检测频率、性传播感染知识、适应性应对、社会支持、性耻辱感、获得护理的机会、抑郁和自尊。我们将进行混合效应回归以计算前后测试平均结果得分的变化。

伦理与传播

已获得加拿大多伦多安大略省多伦多大学研究伦理办公室(研究伦理委员会:29291)的研究伦理批准。无论结果如何,试验结果都将根据非随机设计评估的透明报告(TREND)声明进行发表。

试验注册号

本研究已在http://clinicaltrials.gov上注册,注册号为NCT02067845。