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了解广泛中和抗体在高危人群中用于预防HIV的可接受性以及在印度引入产品的可行性考量:一项定性研究方案

Understanding the Acceptability of Broadly Neutralizing Antibodies for HIV Prevention Among At-Risk Populations and Feasibility Considerations for Product Introduction in India: Protocol for a Qualitative Study.

作者信息

Mukherjee Joyeeta, Rawat Shruta, Ul Hadi Saif, Aggarwal Pritha, Chakrapani Venkatesan, Rath Pratyasha, Manchi Pallavi, Aylur Srikrishnan, Malhotra Shelly, Keane Margaret, Gangaramany Alok

机构信息

International AIDS Vaccine Initiative, Gurugram, India.

The Humsafar Trust, Mumbai, India.

出版信息

JMIR Res Protoc. 2024 Feb 7;13:e47700. doi: 10.2196/47700.

Abstract

BACKGROUND

Acceptability and preference research play a crucial role in the design, evaluation, and implementation of any new prevention product in any geographical setting. They also play a critical role in the development of clinical guidelines and policies. A wide range of acceptability studies have been conducted in diverse general and key populations for various new HIV prevention products worldwide. As clinical development strategies are being developed for clinical studies of broadly neutralizing antibodies (bNAbs) as potential HIV prevention products, appropriately tailoring them to address the type of HIV epidemic at hand would be critical for efficient uptake within in-country public health systems and decrease adoption and adherence challenges. Accomplishing this will require comprehensive acceptability and feasibility studies to inform multisectoral efforts that increase access to these products and national policies supportive of access to health care for those in most need. Thus, it is both opportune and important to undertake focused efforts toward informing product development strategies.

OBJECTIVE

This study aims to understand preferences for product attributes and key behavioral factors influencing adoption and uptake of bNAb prevention products among end-users including female sex workers, men who have sex with men, transgender women, people who inject drugs, and adolescent girls and young women in India and understand the key health system and programmatic perspectives toward the introduction of bNAb prevention products from health service providers and policy makers in India.

METHODS

A multisite study will be conducted in Delhi, Mumbai, and Chennai to capture the differences in perspectives among diverse end-users and key informants across the country. The study will use a multimethods design using focus group discussions, in-depth interviews, simulated behavioral experiments, and key informant interviews. A total of 30 focus group discussions, 45 in-depth interviews, 15 simulated behavioral experiments sessions, and 15 key informant interviews will be conducted across 3 sites.

RESULTS

The data collected and analyzed will enable insights on which specific product attributes matter the most to the populations and why some attributes are less preferred; contextual drivers of preferences and choices at individual, interpersonal, social, and structural levels; and relative positioning of bNAb products among other potential HIV prevention products. Insights from the health service providers and policy makers will provide a critical understanding of the need perception of the potential product in the existing product landscape and what additional efforts and resources are required for potential introduction, delivery, and uptake of the bNAb products in the Indian context.

CONCLUSIONS

Insights generated from the abovementioned objectives will represent perspectives of populations of interest across geographies in India, will provide an overview of the acceptability of bNAb products and the feasibility of their introduction in this region, and will inform product development strategies.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47700.

摘要

背景

可接受性和偏好研究在任何地理环境中任何新预防产品的设计、评估和实施中都起着至关重要的作用。它们在临床指南和政策的制定中也发挥着关键作用。全球针对各种新的艾滋病毒预防产品,在不同的普通人群和关键人群中开展了广泛的可接受性研究。随着正在制定将广泛中和抗体(bNAb)作为潜在艾滋病毒预防产品进行临床研究的临床开发策略,根据当前艾滋病毒流行类型进行适当调整对于在国内公共卫生系统中有效采用以及减少采用和依从性方面的挑战至关重要。要实现这一点,将需要全面的可接受性和可行性研究,以为多部门努力提供信息,这些努力旨在增加获得这些产品的机会以及制定支持最需要者获得医疗保健的国家政策。因此,集中精力为产品开发策略提供信息既适时又重要。

目的

本研究旨在了解印度女性性工作者、男男性行为者、变性女性、注射吸毒者以及少女和年轻女性等终端用户对bNAb预防产品属性的偏好以及影响其采用和使用的关键行为因素,并了解印度卫生服务提供者和政策制定者对引入bNAb预防产品的关键卫生系统和规划观点。

方法

将在德里、孟买和金奈开展一项多地点研究,以捕捉全国各地不同终端用户和关键信息提供者观点的差异。该研究将采用多方法设计,包括焦点小组讨论、深入访谈、模拟行为实验和关键信息提供者访谈。将在3个地点共进行30次焦点小组讨论、45次深入访谈、15次模拟行为实验环节以及15次关键信息提供者访谈。

结果

收集和分析的数据将有助于深入了解哪些特定产品属性对人群最为重要以及为何某些属性不太受欢迎;个人、人际、社会和结构层面偏好和选择的背景驱动因素;以及bNAb产品在其他潜在艾滋病毒预防产品中的相对定位。卫生服务提供者和政策制定者的见解将提供对现有产品格局中潜在产品的需求认知的关键理解,以及在印度背景下潜在引入、交付和使用bNAb产品需要哪些额外努力和资源。

结论

从上述目标中得出的见解将代表印度不同地区相关人群的观点,将概述bNAb产品的可接受性及其在该地区引入的可行性,并将为产品开发策略提供信息。

国际注册报告识别号(IRRID):DERR1-10.2196/47700。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8571/10882480/76fda89536da/resprot_v13i1e47700_fig1.jpg

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