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WeExPAnd 方案:在美国南部增加艾滋病毒感染脆弱女性人群使用暴露前预防措施的前瞻性混合方法初步示范研究。

Protocol for WeExPAnd: a prospective, mixed-methods pilot demonstration study to increase access to pre-exposure prophylaxis among women vulnerable to HIV infection in the Southern USA.

机构信息

Department of Psychiatry, Massachusetts General Hospital / Harvard Medical School, Boston, Massachusetts, USA

Department of Psychiatry, Massachusetts General Hospital / Harvard Medical School, Boston, Massachusetts, USA.

出版信息

BMJ Open. 2023 Jun 7;13(6):e075250. doi: 10.1136/bmjopen-2023-075250.

DOI:10.1136/bmjopen-2023-075250
PMID:37286316
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10255226/
Abstract

INTRODUCTION

African American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may circumvent barriers to traditional HIV prevention tools, such as condom use; however, very little is known about how to improve PrEP access and uptake among AA women who may benefit from PrEP use. This project aims to understand how to increase PrEP access among AA women in the rural Southern USA, which may ultimately affect HIV incidence in this population.

METHODS AND ANALYSIS

The goal of the current study is to systematically adapt a patient-provider communication tool to increase PrEP uptake among AA women receiving care at a federally qualified health centre in Alabama. We will use an iterative implementation process, by assessing the feasibility, acceptability and preliminary impact of the tool on PrEP uptake, using a pilot preintervention/postintervention design (N=125). We will evaluate women's reasons for declining a referral to a PrEP provider, reasons for incomplete referrals, reasons for not initiating PrEP after a successful referral and ongoing PrEP use at 3 and 12 months after PrEP initiation among our sample. The proposed work will significantly contribute to our understanding of factors impacting PrEP uptake and use among AA women, particularly in underserved areas in the Deep South that are heavily impacted by the HIV epidemic and experience worse HIV-related health outcomes relative to other areas in the USA.

ETHICS AND DISSEMINATION

This protocol has been approved by the Institutional Review Board (IRB) at University of Alabama at Birmingham (Birmingham, AL; protocol 300004276). All participants will review a detailed informed consent form approved by the IRB and will provide written or verbal informed consent prior to enrolment. Results will be disseminated through peer-reviewed manuscripts, reports, and local, national and international presentations.

TRIAL REGISTRATION NUMBER

NCT04373551.

摘要

简介

非裔美国女性(AA),尤其是生活在美国东南部的非裔美国女性,感染艾滋病毒的比例过高。暴露前预防(PrEP)是一种非常有效的艾滋病毒预防工具,可以规避传统艾滋病毒预防工具(如使用避孕套)的障碍;然而,对于如何提高可能受益于 PrEP 使用的 AA 女性获得 PrEP 的机会和使用 PrEP 的机会,知之甚少。本项目旨在了解如何增加美国南部农村地区 AA 女性获得 PrEP 的机会,这最终可能会影响该人群的艾滋病毒发病率。

方法和分析

目前的研究目标是系统地改编医患沟通工具,以增加在阿拉巴马州一家符合联邦资格的健康中心接受护理的 AA 女性接受 PrEP 的机会。我们将使用迭代实施过程,通过使用试点预干预/后干预设计(N=125)评估工具对 PrEP 接受度的可行性、可接受性和初步影响来评估该工具。我们将评估女性拒绝转介给 PrEP 提供者的原因、转介不完整的原因、成功转介后未开始 PrEP 的原因以及在 PrEP 开始后 3 个月和 12 个月持续使用 PrEP 的原因。拟议的工作将大大有助于我们了解影响 AA 女性接受 PrEP 和使用 PrEP 的因素,特别是在深受艾滋病毒流行影响且与美国其他地区相比艾滋病毒相关健康结果更差的南部腹地服务不足地区。

伦理和传播

本方案已获得阿拉巴马大学伯明翰分校机构审查委员会(IRB)的批准(伯明翰,AL;方案 300004276)。所有参与者将审查 IRB 批准的详细知情同意书,并在入组前提供书面或口头知情同意。结果将通过同行评议的手稿、报告以及本地、国家和国际演讲传播。

试验注册号

NCT04373551。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ceae/10255226/295cdccd1d74/bmjopen-2023-075250f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ceae/10255226/debc43e989cb/bmjopen-2023-075250f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ceae/10255226/295cdccd1d74/bmjopen-2023-075250f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ceae/10255226/debc43e989cb/bmjopen-2023-075250f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ceae/10255226/295cdccd1d74/bmjopen-2023-075250f02.jpg

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